Raxibacumab- Approved for the treatment of inhalational Anthrax

         
         The U.S FDA today approved raxibacumab a monoclonal antibody in the prophylaxis and treatment of inhalational anthrax. Anthrax is a disease caused by Bacillus anthracis bacteria.Inhalational form is also known as wool sorter’s disease as workers in wool industry inhale the spores of bacillus anthracis while sorting out the wool.Anthrax has also been tried to use as a weapon of bioterrorism.
         Raxibacumab is a chimeric monoclonal antibody targeting the protective antigen (PA) component of the lethal toxin of Bacillus anthracis. In case of bioterrorism by the use of anthrax spores, raxibacumab is available along with the antibiotics.
                   More animals treated with raxibacumab lived compared to animals treated with placebo. Sixty-four percent of animals in the monkey study and 44 percent of animals in one rabbit study receiving the 40 milligrams per kilogram dose of raxibacumab survived exposure to anthrax, compared with none in the placebo groups. All surviving animals developed toxin-neutralizing antibodies. Another study in rabbits showed that 82 percent of animals treated with antibiotics and raxibacumab survived exposure to anthrax compared with 65 percent of animals receiving antibiotic treatment alone.
             The safety of raxibacumab was evaluated in 326 healthy human volunteers. Common side effects included rash, extremity pain, itching and drowsiness.
        Raxibacumab was developed by Rockville, Md.-based Human Genome Sciences, in conjunction with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority. Human Genome Sciences has since been acquired by GlaxoSmithKline.
Source:http://http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm332341.htm
 

FDA approves Signifor® for the treatment of Cushing’s Disease

                                                        Signifor (pasireotide diaspartate) ,an orphan drug ,an analogue of somatostatin has been approved by the FDA for the treatment of Cushing’s disease on 14th Dec 2012. Signifor has been developed by Novartis.

                Cushing’s disease is a condition caused by pituitary adenoma ,which leads to overstimulation of adrenal glands and overproduction of cortisol. Leading to spectrum of signs symptoms including central obesity, buffalo hump,purple striae, altered diurnal variation, hyperglycemia,hypertension hirsutism and many more. There is one more entity called Cushing’s syndrome which has same range of signs and symptoms but caused due to other peripheral causes most commonly being iatrogenic i.e steroid administration.

           Usually Cushing's disease is due to pituitary adenoma or a small tumour which is removed surgically. In patients in whom it cannot removed surgically, Signifor can be given. It is a somatostatin analogue which acts mainly on somatostatin receptor 5. 

               ^{FDA approved Signifor based on the results of PASPORT-CUSHINGS (PASireotide clinical trial PORTfolio - CUSHING'S disease).Results from the PASPORT-CUSHINGS study found that a decrease in mean urinary-free cortisol (UFC), the key measure of biochemical control of the disease, was sustained during the treatment period in most patients with a subset of patients reaching normal levels. The study also showed that certain clinical manifestations of Cushing's disease tended to improve.}

           ^{Signifor is given subcutaneously. The important side effects being hyperglycemia, diarrhea, nausea, abdominal pain, and gallstones.}

 

^{Source:http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm332351.htm} 

Cometriq - Approved for Medullary thyroid cancer

          

           The U.S  FDA on 29th nov 2012 approved Cometriq (cabozantinib) , inhibitor of the tyrosine kinases c-Met and VEGFR2 effective in the treatment of progressive, metastatic Medullary Thyroid Carcinoma (MTC).
              It is the second drug approved by the US FDA for the treatment of MTC , fist being  Caprelsa (vandetanib). MTC is a cancer arising from parafollicular C cells in the thyroid gland ,which normally secrete calcitonin - calcium lowering hormone. MTC is a cancer difficult to treat especially if it has metastasized. MTC diagnosed early are treated with total thyroidectomy.MTC is associated with familial cancer syndromes MEN(Multiple endocrine neoplasia) 2A and 2B. It is a rare type of thyroid cance with amounting to only 4% of all thyroid cancers.
            With the approval of Cometriq patients with advanced MTC will have a new ray of hope.

Source : http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm330143.htm

Collodion Baby

             Lamellar ichthyosis (LI) is an autosomal recessive disorder that is apparent at birth and is present throughout life. The newborn is born encased in a collodion membrane that sheds within 10-14 days. The shedding of the membrane reveals generalized scaling with variable redness of the skin. The scaling may be fine or platelike, resembling fish skin. Although the disorder is not life threatening, it is quite disfiguring and causes considerable psychological stress to affected patients. Ectropion will be present. There will be macroglossia.

       Patients with lamellar ichthyosis have accelerated epidermal turnover with proliferative hyperkeratosis, in contrast to retention hyperkeratosis. This involves a mutation in the gene for transglutaminase 1 (TGM1). The transglutaminase 1 enzyme is involved in the formation of the cornified cell envelope. The formation of the cornified cell envelope is an essential scaffold upon which normal intercellular lipid layer formation in the stratum corneum occurs. Thus, mutations in the TGM1 secondarily cause defects in the intercellular lipid layers in the stratum corneum, leading to defective barrier function of the stratum corneum and to the ichthyotic phenotype seen in lamellar ichthyosis patients and in transglutaminase 1 knockout mice. How much a defective cornified cell envelope alone contributes to the barrier abnormality in ichthyoses remains unclear.^[1]

To date, 6 genes for lamellar ichthyosis have been localized and 5 of them identified, as follows^[2] :

• TGM1 (14q11)

• ABCA12 (2q34)

• 19p12-q12

• 19p13

• ALOXE3-ALOX12B (17p13)

• ichthyin (5q33) 

In the neonatal period, following the shedding of the collodion membrane, the newborn is at risk for secondary sepsis and hypernatremic dehydration.

As the child ages, the hyperkeratosis can interfere with normal sweat gland function, which can predispose to heat intolerance and possible heat shock. Ectropion may result in the inability to fully close the eyelids and can cause exposure keratitis.

  Recently , a case was reported in ESI Post Graduate Institute of Medical Sciences and Research,  Rajajinagar,Bangalore.

Picture Courtesy : Dr.Tejaswini Hiremath  MS OBG(std) ESIPGIMSR,Bangalore, India

Ref: 1. http://emedicine.medscape.com/article/1111300-overview

      2. http://indianpediatrics.net/dec2001/dec-1428.htm

The Amazing Spider Surgery!

             As the Amazing Spiderman hits the theatres all over the world, the amazing ‘spider surgery technology’ is all set to create buzz in the Asia Pacific minimal access surgical field. Dr Pradeep Chowbey, who heads the Max Institute of Minimal Access, Metabolic and Bariatric Surgery, be at the helm of spider surgery in Asia pacific region for the first time on 10th July 2012.

           In the conventional laparoscopic surgery there are at least 4 to 5 ports/small incisions around the umbilicus for the insertion of various instruments including a camera.

       But in Spider surgical system,the surgeon inserts the SPIDER Surgical System through a single incision usually located near the patient's belly button. The system opens up umbrella-like within the abdomen, providing the surgeon with two flexible channels for right- and left-hand instruments with 360-degree range of motion, and two rigid channels for small cameras and other instruments. Once the procedure is completed, the SPIDER Surgical System closes up and is removed through the same incision.

    The spider surgical system is presently used for appendectomy, gall bladder surgeries and mainly bariatric surgeries. With the periodic transition in the field of abdominal surgeries this Spider tech is said to be a giant leap..

Source: http://www.transenterix.com/spider-surgical-system.php 

Electronic Resources in Medicine (ERMED) Consortium

               ERMED-India Consortium , is an effort in India by Director General of Heath Services (DGHS) of Govt. of India to develop nation wide electronic information resources in the field of medicine in India. The authorities provide financial support for the Govt. Medical colleges to purchase electronic journals. The ERMED is coordinated through National Medical Library situated in New Delhi.The Govt. Medical colleges can join this initiative free of charge. The leading E journals provided by ERMED are

1. American Academy of Pediatrics
2. BMJ Publishing
3. Cambridge University Press
4. Cengage Learning
5. IOS Press
6. Lippincott William Wilkins
7. Oxford University Press
8. Royal Society of Medicine Press

  To join ERMED the following application is to be filled

http://nmlermed.in/Application.pdf

The applications should be sent to the address below

National Medical Library
Ansari Nagar,
Ring Road,
New Delhi-110029.
Ph: 011-26589085,26589128,26589489
e-mail: nationalmedicallibrary66@yahoo.in

http://nmlermed.in/howToJoin.htm

            Most of  the Govt. Medical colleges in India are lagging behind in Research and recent advances in the world of medicine because of various reasons. ERMED is an effort to help the medical colleges and students to update themselves with newer things.

For more details visit

http://nmlermed.in/main.htm

Steve Jobs’ speech @ Stanford Versity

Stay Hungry, Stay Foolish.

iPhone apps for Doctors

           Since ages it’s a general perception that doctors are considered to be weak in technical things and poor in gadget using. Now the time has changed with , whole of the medical profession is being dependent on gadgets.The days of bedside teaching , learning and being proud of ones clinical skills will become like test cricket in years to come. Change is the principle of nature and in the struggle for existence the most adaptable will survive. Its becoming mandatory to use medical applications in our smart phones for quick response during emergencies.. Here are few medical applications for iPhone. The first one in the review series of the medical apps.

1. Heart pro

3D4Medical in collaboration with Stanford University School of Medicine present the Heart Pro III. As featured in the WWDC 2012 Keynote Speech. This app was developed in partnership with Dr. Lacy E Harville III, MD, FACS.
In this upgrade 3D4Medical have added in several new features and several new animations all for free.
Built in Animations:
-Anterior Beating Heart - Aortic Stenosis - Conduction Heart Beat - Heart Catheterization-Ischemic Stroke - Myocardial Heart Attack - Patent Ductus Arteriosus (PDA) - Ventricular Fibrillation - Ventricular Septal Defect - Blood Flow (slow speed) - Blood Flow in Beating Heart - Coronal Cut (Ant.) Beating Heart - Lateral Beating Heart - Posterior Beating Heart - Right Lateral Beating Heart - Sagittal Cut (Lat) Beating Heart - Transverse Cut (Ant) Beating Heart - Aortic Valve - Left Atrium - Left Ventricle - Mitral Valve - Pulmonary Valve - Right Atrium - RightVentricle Tricuspid Valve.

 

To buy the app visit 

http://itunes.apple.com/us/app/heart-pro-iii/id393231526?mt=8

Stay Hungry, Stay Foolish….

As my mind wanders through the uncertainties of life, i found this inspiring speech by Steve Jobs.

Steve Jobs' 2005 commencement address at Stanford University.

      I am honoured to be with you today at your commencement from one of the finest universities in the world. I never graduated from college. Truth be told, this is the closest I've ever gotten into a college graduation. Today I want to tell you three stories from my life. That's it. No big deal. Just three stories.The first story is about connecting the dots.I dropped out of Reed College after the first 6 months, but then stayed around as a drop-in for another 18 months or so before I really quit. So why did I drop out?It started before I was born. My biological mother was a young, unwed college graduate student, and she decided to put me up for adoption. She felt very strongly that I should be adopted by college graduates, so everything was all set for me to be adopted at birth by a   lawyer and his wife. Except that when I popped out they decided at the last minute that they  really wanted a girl. So my parents, who were on a waiting list, got a call in the middle of the  night asking: "We have an unexpected baby boy; do you want him?" They said: "Of course."My biological mother later found out that my mother had never graduated from college and that my father had never graduated from high school. She refused to sign the final adoption papers. She only relented a few months later when my parents promised that I would someday go to college.And 17 years later I did go to college. But I naively chose a college that was almost as expensive as Stanford, and all of my working-class parents' savings were being spent on my college tuition. After six months, I couldn't see the value in it. I had no idea what I wanted to  do with my life and no idea how college was going to help me figure it out. And here I was spending all of the money my parents had saved their entire life. So I decided to drop out and trust that it would all work out OK. It was pretty scary at the time, but looking back it was one  of the best decisions I ever made. The minute I dropped out I could stop taking the required classes that didn't interest me, and begin dropping in on the ones that looked interesting.It wasn't all romantic. I didn't have a dorm room, so I slept on the floor in friends' rooms,  I returned coke bottles for the 5¢ deposits to buy food with, and I would walk the 7 miles across town every Sunday night to get one good meal a week at the Hare Krishna temple. I loved it.And much of what I stumbled into by following my curiosity and intuition turned out to be priceless later on. Let me give you one example:Reed College at that time offered perhaps the best calligraphy instruction in the country.Throughout the campus every poster, every label on every drawer, was beautifully hand calligraphed. Because I had dropped out and didn't have to take the normal classes, I decided to take a calligraphy class to learn how to do this. I learned about serif and san serif typefaces, about varying the amount of space between different letter combinations, about what makes great typography great. It was beautiful, historical, artistically subtle in a way that science can't capture, and I found it fascinating.None of this had even a hope of any practical application in my life. But ten years later, when we were designing the first Macintosh computer, it all came back to me. And we designed it all into the Mac. It was the first computer with beautiful typography. If I had never dropped in on  that single course in college, the Mac would have never had multiple typefaces or proportionally spaced fonts. And since Windows just copied the Mac, it's likely that no personal computer would have them. If I had never dropped out, I would have never dropped in on this calligraphy class, and personal computers might not have the wonderful typography that they do. Of course it was impossible to connect the dots looking forward when I was in college. But it was very, very clear looking backwards ten years later.Again, you can't connect the dots looking forward; you can only connect them looking backwards. So you have to trust that the dots will somehow connect in your future. You have to trust in something — your gut, destiny, life, karma, whatever. This approach has never let me down, and it has made all the difference in my life.

            My second story is about love and loss.I was lucky — I found what I loved to do early in life. Woz and I started Apple in my parents garage when I was 20. We worked hard, and in 10 years Apple had grown from just the two of us in a garage into a $2 billion company with over 4000 employees. We had just released our finest creation — the Macintosh — a year earlier, and I had just turned 30. And then I got  fired. How can you get fired from a company you started? Well, as Apple grew we hired someone who I thought was very talented to run the company with me, and for the first year or so things went well. But then our visions of the future began to diverge and eventually we had a falling out. When we did, our Board of Directors sided with him. So at 30 I was out. And very publicly out. What had been the focus of my entire adult life was gone, and it was devastating.I really didn't know what to do for a few months. I felt that I had let the previous generation of entrepreneurs down - that I had dropped the baton as it was being passed to me. I met with David Packard and Bob Noyce and tried to apologize for screwing up so badly. I was a very public failure, and I even thought about running away from the valley. But something slowly began to dawn on me — I still loved what I did. The turn of events at Apple had not changed that one bit. I had been rejected, but I was still in love. And so I decided to start over.I didn't see it then, but it turned out that getting fired from Apple was the best thing that could have ever happened to me. The heaviness of being successful was replaced by the lightness of being a beginner again, less sure about everything. It freed me to enter one of the most creative periods of my life.

     During the next five years, I started a company named NeXT, another company named Pixar,and fell in love with an amazing woman who would become my wife. Pixar went on to create the worlds first computer animated feature film, Toy Story  , and is now the most successful animation studio in the world. In a remarkable turn of events, Apple bought NeXT, I returned to Apple, and the technology we developed at NeXT is at the heart of Apple's current renaissance. And Laurene and I have a wonderful family together.I'm pretty sure none of this would have happened if I hadn't been fired from Apple. It was awful tasting medicine, but I guess the patient needed it. Sometimes life hits you in the head with a brick. Don't lose faith. I'm convinced that the only thing that kept me going was that I loved what I did. You've got to find what you love. And that is as true for your work as it is for your lovers. Your work is going to fill a large part of your life, and the only way to be truly satisfied is to do what you believe is great work. And the only way to do great work is to love  what you do. If you haven't found it yet, keep looking. Don't settle. As with all matters of the heart, you'll know when you find it. And, like any great relationship, it just gets better and better as the years roll on. So keep looking until you find it. Don't settle.

    My third story is about death.When I was 17, I read a quote that went something like: "If you live each day as if it was your  last, someday you'll most certainly be right." It made an impression on me, and since then,for the past 33 years, I have looked in the mirror every morning and asked myself: "If today were the last day of my life, would I want to do what I am about to do today?" And whenever the answer has been "No" for too many days in a row, I know I need to change something.Remembering that I'll be dead soon is the most important tool I've ever encountered to help me make the big choices in life. Because almost everything — all external expectations, all pride, all fear of embarrassment or failure - these things just fall away in the face of death,leaving only what is truly important. Remembering that you are going to die is the best way I know to avoid the trap of thinking you have something to lose. You are already naked. There is no reason not to follow your heart.About a year ago I was diagnosed with cancer. I had a scan at 7:30 in the morning, and it clearly showed a tumour on my pancreas. I didn't even know what a pancreas was. The doctors told me this was almost certainly a type of cancer that is incurable, and that I should expect to live no longer than three to six months. My doctor advised me to go home and get my affairs in order, which is doctor's code for prepare to die. It means to try to tell your kids everything you thought you'd have the next 10 years to tell them in just a few months. It means to make sure everything is buttoned up so that it will be as easy as possible for your family. It means to say your goodbyes.I lived with that diagnosis all day. Later that evening I had a biopsy, where they stuck an endoscope down my throat, through my stomach and into my intestines, put a needle into my  pancreas and got a few cells from the tumor. I was sedated, but my wife, who was there, told me that when they viewed the cells under a microscope the doctors started crying because it turned out to be a very rare form of pancreatic cancer that is curable with surgery. I had the surgery and I'm fine now.This was the closest I've been to facing death, and I hope it's the closest I get for a few more decades. Having lived through it, I can now say this to you with a bit more certainty than when death was a useful but purely intellectual concept:No one wants to die. Even people who want to go to heaven don't want to die to get there.And yet death is the destination we   all share. No one has ever escaped it. And that is as it should be, because Death is very likely the single best invention of Life. It is Life's change  agent. It clears out the old to make way for the new. Right now the new is you, but someday not too long from now, you will gradually become the old and be cleared away. Sorry to be so dramatic, but it is quite true.Your time is limited, so don't waste it living someone else's life. Don't be trapped by dogma —which is living with the results of other people's thinking. Don't let the noise of others' opinions drown out your own inner voice. And most important, have the courage to follow your heart and intuition. They somehow already know what you truly want to become. Everything else is secondary.When I was young, there was an amazing publication called The Whole Earth Catalogue, which was one of the bibles of my generation. It was created by a fellow named Stewart Brand not far from here in Menlo Park, and he brought it to life with his poetic touch. This was in the late1960's, before personal computers and desktop publishing, so it was all made with typewriters, scissors, and polaroid cameras. It was sort of like Google in paperback form, 35years before Google came along: it was idealistic, and overflowing with neat tools and great notions.Stewart and his team put out several issues of The Whole Earth Catalog, and then when it had run its course, they put out a final issue. It was the mid-1970s, and I was your age. On the back cover of their final issue was a photograph of an early morning country road, the kind you might find yourself hitchhiking on if you were so adventurous. Beneath it were the words:"Stay Hungry. Stay Foolish." It was their farewell message as they signed off. Stay Hungry.Stay Foolish. And I have always wished that for myself. And now, as you graduate to begin a new, I wish that for you.

Stay Hungry. Stay Foolish.

Thank you all very much

FDA approves Myrbetriq for overactive bladder

The U.S. Food and Drug Administration   28th June approved Myrbetriq (mirabegron) to treat adults with overactive bladder, a condition in which the urinary bladder muscle cannot be controlled, squeezes too often or squeezes without warning.

An extended-release tablet taken once daily, Myrbetriq improves the storage capacity of the bladder by relaxing the bladder muscle during filling. Symptoms of overactive bladder include the need to urinate too often (urinary frequency), the need to urinate immediately (urinary urgency), and the involuntary leakage of urine as a result of the need to urinate immediately (urge urinary incontinence).

“An estimated 33 million Americans suffer from overactive bladder, which is uncomfortable, disrupting and potentially serious,” said Victoria Kusiak, M.D., deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “Today’s approval provides a new treatment option for patients with this debilitating condition.”

Myrbetriq’s safety and efficacy were demonstrated in three double-blind, placebo-controlled, multicenter clinical trials. A total of 4,116 patients with overactive bladder were randomly assigned to take Myrbetriq at doses of 25 milligrams, 50 mg, 100 mg, or a placebo once daily for 12 weeks.

Results showed that Myrbetriq 25 mg and 50 mg effectively reduced the number of times a patient urinated and the number of times a patient had wetting accidents during a 24-hour period. Patients taking Myrbetriq 50 mg also expelled a greater amount of urine, demonstrating the drug’s effectiveness in improving the storage capacity of the bladder.

The most common side effects observed in the trials were increased blood pressure, common cold-like symptoms (nasopharyngitis), urinary tract infection, constipation, fatigue, elevated heart rate (tachycardia), and abdominal pain. Myrbetriq is not recommended for use in those with severe uncontrolled high blood pressure, end stage kidney disease or severe liver impairment.

Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310096.htm

Photodynamic therapy increases survival in Malignant Pleural Mesothelioma

       Mesothelioma is a malignant cancer usually associated with asbestos exposure. The development of mesothelioma may take longer than 10 to 15 years after the persistent exposure of asbestos.It usually affects pleura,lungs and it is extremely aggressive.The treatment is not satisfactory for mesothelioma.Only 3-4 out of 10 patients survive for more than an year after treatment.The treatment usually involves lung sparing surgery.

  Recently a group of researchers from the Perelman School of Medicine, University of Pennsylvania reported in Annals of Thoracic Surgery that Photodynamic therapy besides lung sparing surgery in cases of malignant mesothelioma increases the survival up to 2years.

The researchers proposed that mesothelioma is bound to recur in treated patients, but if they can have functional lungs they can sustain treatment in case of recurrence. So photodynamic therapy helps in having functional lungs in spite of treatment and thus increasing the survival rates in mesothelioma patients.

Source: http://ats.ctsnetjournals.org/cgi/gca?allch=&SEARCHID=1&AUTHOR1=Joseph%2BFriedberg&FIRSTINDEX=0&hits=10&RESULTFORMAT=&gca=annts%3B93%2F5%2F1658&allchb=

PCSOA 2011 - Raising age of consent for sex to 18

        Protection of Children from Sexual Abuses act 2011. The parliament of India passed this bill recently and raised the age for consent for sex from 16yrs to 18yrs. Recently a trial court has termed this law which raises the age for consent for sex from16 to 18yrs as ‘undemocratic’ and regressive’. It also stated that this act can be used as a tool by law enforcing authorities to harass minors especially boys.

       The court clarified that it was against teenage sex but raising the age is not the solution. "Good virtues cannot be inculcated and good conscience cannot be imbibed in a child by legal provisions. It would be better and wiser to leave this job to parents and school teachers...Children need to be imparted sex education in the schools," said the court. These observations made by the court in the case of Sandeep Paswan ,facing trial for kidnapping and raping a minor girl who had eloped with him.

    As already the bill has been passed in the parliament, the Govt. should think on these lines and reconsider the raising of age for consent for sex.

You can get the full text of PCSOA 2011 here

http://164.100.24.219/BillsTexts/RSBillTexts/asintroduced/protection%20children.pdf

Abacavir and Autoimmunity

        Recently FDA led team has discovered Autoimmunity caused by Abacavir in at-risk patients on ART.Abacavir acts on HLA B*5701 which helps the immune system to distinguish between the 'self' and the 'foreign' antigens. By acting on HLA B*5701 the body starts recognizing its own tissues as foreign and thus autoimmunity comes into picture. This discovery is a break through discovery  in the knowing, why certain drugs cause allergic reactions in certain patients.

Source: http://journals.lww.com/aidsonline/pages/default.aspx
          
            http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm305067.htm

Life se panga mat le yaar...

Life is so precious.... Shaan being brand ambassador for anti tobacco campaign sings 'Life se panga mat le yaar'

Tobacco industry interference

     31st May is world No Tobacco Day. People consume Tobacco under status mania, peer pressure or depending on the environment where the person lives. Govt agencies have taken initiative to discourage people from using tobacco products. But in the age of marketing and commercialization , the efforts by lawmaking authorities and few NGOs is being negated by the aggressive interference of tobacco industry by means of ads and marketing.So theme of this year's World No Tobacco day is 'Tobacco industry interference'.
       According to a recent research smoking could cause 40 million excess deaths among smokers, who also suffer from tuberculosis (TB) by 2050. The study, led by Sanjay Basu from the University of California, San Francisco, used a maths model to determine the effect of smoking on future TB rates, the BMJ (British Medical Journal) reports. Tt shows that from 2010 to 2050 smoking could lead to 40 million excess TB deaths worldwide – from 61 to 101 million.
They also conclude that if current smoking trends continue, the number of excess TB cases could rise from 256 to 274 million – 18 million new cases in total. “Aggressively lowering the prevalence of tobacco smoking could reduce smoking attributable deaths from tuberculosis by 27 million by 2050,” Basu said, according to a California statement.
    Nearly one-fifth of the world’s population smokes and that most cigarettes are smoked in countries with high TB prevalence. Given this, the authors wanted to predict how much impact smoking will have on future TB rates. Researchers found that smoking may have a substantial impact on future TB rates because a moderate increase in individual risk translates into a large population-level risk.

FDA approves new silicone gel-filled breast implant

Approval conditioned on post-approval safety studies

    On 9th March 2012, the U.S. Food and Drug Administration approved a silicone gel-filled breast implant manufactured by Sientra Inc. to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age.

As a condition of approval, Sientra is required to conduct post-approval studies that will assess long-term safety and effectiveness outcomes as well as the risks of rare disease outcomes.

Silicone gel-filled breast implants are medical devices implanted under the breast tissue or under the chest muscle for breast augmentation or reconstruction. These implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells.

Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.

Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.

With today’s approval, there are now three FDA-approved silicone gel-filled breast implants in the U.S. manufactured by Allergan, Mentor and Sientra.

“Data on these and other approved silicone gel-filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness,” said William Maisel, M.D., M.P.H., deputy director for science in the FDA’s Center for Devices and Radiological Health.

“It’s important to remember that breast implants are not lifetime devices. Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential.” said Maisel.

The FDA based its Sientra approval on three years of clinical data from 1,788 participants. Complications and outcomes reflected those found in previous studies of other breast implants and included tightening of the area around the implant (capsular contracture), re-operation, implant removal, an uneven appearance (asymmetry), and infection.

In June 2011, the FDA released a report that included preliminary safety data from post-approval studies from earlier breast implant approvals. The experience collecting and analyzing data from these studies informed the design and structure of post-approval studies for Sientra breast implants.

In addition to other post-approval conditions, Sientra will:

• continue to follow the 1,788 clinical trial participants in their pre-market study for an additional 7 years;
• conduct a 10-year study of 4,782 women receiving Sientra silicone gel-filled breast implants to collect information on long-term local complications such as capsular contracture, as well as less common disease outcomes, such as rheumatoid arthritis and breast and lung cancer; and
• conduct five case-control studies that will evaluate the association between Sientra’s silicone gel-filled breast implants and five rare diseases: rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer, and lymphoma.

“The design of these post-approval studies will require Sientra to collect valuable safety information with adequate enrollment and follow-up,” said Maisel. “The FDA is committed to working with breast implant manufacturers to collect useful post-market data on long-term safety and effectiveness.”

Sientra Inc. is based in Santa Barbara, Calif.

Source:http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm295429.htm

Indian Academy of Pediatrics Immunization Schedule

     Immunization has become an essential component of primary health in India since long time.There is Universal Immunization program which has been adopted to Indian situation and with slight modifications National immunization program has been implemented by the Govt of India. But Indian Academy of Pediatrics recommends few extra vaccines and protocols for immunization.The IAP Immunization schedule as follows….

  

Source: http://www.iapindia.org/immunisation/immunisation-schedule

Weight loss prevents urinary incontinence in obese women with type 2 Diabetes

       The Look AHEAD (Action for Health in Diabetes) trial recently came out with conclusion that moderate weight loss in obese/overweight type 2 diabetic women. The study determined the effect of weight loss on the prevalence, incidence and resolution of weekly or more frequent urinary incontinence in overweight/obese women with type 2 diabetes after 1 year of intervention.

     The urinary incontinence is one of the prominent problems in obese women with DM Type 2 though incontinence doesn’t depend on the weight. Women in this substudy (2,739, mean ± SD age 57.9 ± 6.8 years, body mass index 36.5 ± 6.1 kg/m²) were randomized into an intensive lifestyle weight loss intervention or a diabetes support and education control condition.

      Moderate weight loss reduced the incidence but did not improve the resolution rates of urinary incontinence at 1 year among overweight/obese women with type 2 diabetes. Weight loss interventions should be considered for the prevention of urinary incontinence in overweight/obese women with diabetes.

Source:http://www.sciencedirect.com/science/article/pii/S0022534711054620

FDA approves two new pancreatic enzyme products to aid food digestion

          Two new pancreatic enzyme products used to help aid food digestion, Ultresa (pancrelipase) and Viokace (pancrelipase), were approved today by the U.S. Food and Drug Administration.

         Ultresa is a delayed-release capsule used to treat children and adults with cystic fibrosis, a serious genetic disorder affecting the lungs and other organs, or other conditions who cannot digest food normally because their pancreas does not make enough pancreatic enzymes.

        Viokace, in combination with a proton pump inhibitor, is used to treat adults who cannot digest food normally. Adults with chronic pancreatitis, a continuing, chronic inflammatory process of the pancreas, or those who have had some or all of their pancreases removed (pancreatectomy) may not digest food normally because they lack needed enzymes or because their enzymes are not released into the bowel (intestine). Viokace’s safety and efficacy in children has not been established.

         “The approvals of Ultresa and Viokace, along with the other approved pancreatic enzyme products, allow health care providers to prescribe the product that is most appropriate for the estimated 200,000 patients in the United States who have pancreatic insufficiency,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research.

     Ultresa and Viokace are the fourth and fifth pancreatic enzyme products approved by FDA. Other FDA-approved pancreatic enzyme products include Creon (2009), Zenpep (2009) and Pancreaze (2010). Approved pancreatic enzyme products meet FDA standards for safety, efficacy and product quality.

     Unapproved pancreatic enzyme products had been available for many years. FDA established a date of April 28, 2010 for the makers of pancreatic enzyme products to stop manufacturing and distributing unapproved products.

   Ultresa and Viokace are marketed by Bridgewater, N.J.-based Aptalis Pharma U.S. Inc.

Source:http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm294143.htm

FDA approves first quadrivalent vaccine to prevent seasonal influenza

      USA FDA has approved FluMist Quadrivalent vaccine to prevent seasonal influenza in people of age group of 2yrs to 49 yrs.It contains  strains of Influenza A and 2 strains of Influenza B.

      “Illness caused by Influenza B virus affects children, particularly young and school-aged, more than any other population,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “A vaccine containing the four virus strains most likely to spread and cause illness during the influenza season offers an additional option to aid in influenza prevention efforts.”

        Vaccination is the best method to prevent influenza. Influenza seasons are unpredictable and can be severe, even deadly. Between 1976 and 2007, estimates of seasonal influenza-associated deaths in the United States ranged from a low of about 3,000 to a high of about 49,000 people.

       The safety and effectiveness of FluMist Quadrivalent is supported by studies conducted previously for the FluMist trivalent formulation and three new clinical studies conducted in the United States involving about 4,000 children and adults. The studies demonstrated that the immune responses were similar between FluMist Quadrivalent and FluMist.

           Adverse reactions reported were similar among those receiving FluMist Quadrivalent and FluMist. The most commonly reported adverse reactions were runny or stuffy nose in both children and adults, and headache and sore throat in adults.

         FluMist Quadrivalent is manufactured by MedImmune LLC of Gaithersburg, Md.

      The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products

Source:http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm294057.htm

Citrus Fruits May Lower Women's Stroke Risk

          Researchers have identified a compound found in oranges, grapefruits, and other citrus fruits that may lower a woman’s stroke risk.

           Previous studies suggest that eating fruits and vegetables helps protect against strokes, and many believe that antioxidant compounds known as flavonoids may explain why, because they have been shown to improve blood vessel function and they have anti-inflammatory effects.

       Among other things, flavonoids give fruits and veggies their vibrant colors. They are also found in chocolate and red wine. By some estimates there are more than 5,000 of them.

      In the newly published study, flavonoids abundant in citrus fruits known as flavanones appeared to give the most protection against stroke.

       Women whose diets included the highest amount of flavanones had a 19% lower risk of suffering a blood-clot-related stroke than women with the lowest intake of the compound.

      “Our study supports the conclusion that flavanones are associated with a modest reduction in stroke risk,” says researcher Kathryn M. Rexrode, MD, MPH, of Boston’s Harvard Medical School and Brigham and Women’s Hospital.

Source:http://www.webmd.com/stroke/news/20120223/citrus-fruits-may-lower-womens-stroke-risk

FDA approves first Helicobacter pylori breath test for children

 

           The first breath test for use in children ages 3 to 17 years to detect Helicobacter pylori (H. pylori) bacterial infections, responsible for chronic stomach inflammation (gastritis) and ulcers, was approved by the U.S. Food and Drug Administration (FDA) on Feb. 22, 2012.

              The FDA first cleared the BreathTek UBT test for adults in 1996. The U.S. Centers for Disease Control and Prevention (CDC) estimates that approximately two-thirds of the world’s population is infected with H. pylori. Most people with this infection never have any symptoms but have a two- to six-fold increased risk of developing gastric cancer and mucosal-associated-lymphoid-type lymphoma compared with uninfected people.

       “Results from this test, when considered with a physician’s assessment of the patient’s history, other risk factors, and professional guidelines, can quickly indicate infection, which allows a physician to initiate appropriate health measures in a timely manner,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in FDA’s Center for Devices and Radiological Health.

      The FDA based its approval of the BreathTek UBT test for children on a multi-center study of 176 patients, comparing its performance to a composite reference method and demonstrating 95.8 percent sensitivity and 99.2 percent specificity. An additional study was done at 1 to 6 months after therapy to support use for post-treatment monitoring of patients.  The sensitivity was 83.3 percent and the specificity was 100 percent. 

BreathTek UBT is manufactured by Otsuka America Pharmaceutical based in Rockville, Md.

Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm293278.htm

WHO takes India's name off polio endemic countries list

          WHO has taken India’s name off the list of polio endemic countries in view of the remarkable progress that India achieved by being polio free for the past one full year. The Union Minister for Health and Family Welfare Shri Ghulam Nabi Azad shared this important development today in the presence of Prime Minister of India Dr Manmohan Singh at the inaugural of the two day Polio Summit 2012 in New Delhi. The Polio Summit organised jointly by the Union Ministry of Health and Family Welfare and Rotary International also saw participation of Federal Minister for Interprovincial Coordination, Government of Pakistan, Mir Hazar Khan Bijrani; Minister of Health and Population, Government of Nepal Rajendra Mahato; Deputy Minister of Health, Government of Sri Lanka, Lalith Dissanayaka; Ministers of State for Health and Family Welfare, Shri Sudip Bandyopadhyay and Shri S Gandhiselvan, Secretary Health and Family Welfare Shri P K Pradhan, Rotary International President Mr. Kalyan Banerjee and The Rotary Foundation Chairman Mr. William Boyd as also subject experts from developing partners who have gathered at the Summit to renew and reinforce their commitment to eradicate polio in India.
        Reaffirming the commitment of India to achieve full immunization, Dr Manmohan Singh said “We must ensure that every Indian child, rich or poor, whether living in Ladakh or in Delhi has equal access to the best immunization. To this ambitious task I commit our government”. He noted that the coordinated efforts of the Government of India with close partnership of States Governments, international organizations and groups including the Rotary International, the World Health Organization and UNICEF and the 23 lakh volunteers as also supervisors, has helped to rid our country of the terrible scourge of Polio. The Prime Minister said “it is a matter of satisfaction that we have completed one year without any single new case of polio being reported from anywhere in the country. This gives us hope that we can finally eradicate polio not only from India but from the face of the entire mother earth. The success of our efforts shows that teamwork pays”.
        Dr Manmohan Singh also emphasized the need for nutritious food, safe drinking water, proper sanitation and education in addition to Universal access to safe vaccines. He said that we need to accelerate our efforts to achieve goal of providing universal access to health care at affordable cost for all our citizens. “The rising cost of health care is another key challenge. We are, therefore focusing our attention towards social security of the poor with regard to their health care. Public expenditure on health has increased from less than 1% of our GDP in 2006-07 to an estimated 1.4% of GDP by the end of the Eleventh Five year Plan. But we will need to work harder and do more if we have to reach our goal of increasing public expenditure on health to at least 2.5% of the GDP. Education and health will be the key priorities of the Twelfth Five Year Plan” he emphasized.
      Recalling India’s journey of combating Polio, the Union Minister for Health and Family Welfare Shri Ghulam Nabi Azad noted that the achievement of one full year without even a single polio case, which is being acclaimed worldwide, is the result of a strong political will at the highest levels making sure that there was never any shortage of resources or funds for the polio eradication initiative. He informed that 27 % of the global expenditure on polio eradication has come from India’s domestic resources. More than 99 percent coverage of children in the two remaining endemic states of Bihar and Uttar Pradesh is unprecedented, not witnessed anywhere else in the world on such a large scale, Shri Azad said. The aggressive mop up response against the polio virus has enabled us to stop further transmission of polio virus. He however added that we are highly mindful of the risks that persist not only on account of indigenous transmission but also importations from other endemic countries. “There is going to be zero tolerance for any new polio case and such a case will be declared as a public health emergency” he reiterated. All the states bordering the neighbouring countries have been alerted to strengthen surveillance for early detection of any imported polio virus. Special booths have been established in the bordering areas like Wagah border and Attari train station in Punjab and Munabo train station in Rajasthan, to ensure that all children under 5 years of age coming from across the border are given polio drops, the Minister added. The Polio Programme in India is the most shining example of strong and effective partnerships, Shri Azad noted. Shri Azad urged that we should re-dedicate ourselves and resolve that we will continue our efforts with the same vigour, so that India can be declared Polio Free by the year 2014
    

Source:http://pib.nic.in/newsite/erelease.aspx?relid=80530

Sequencing Human DNA in 15 mins- Revolution

      

          Oxford Nanopore, leading firm  in the field of mapping DNA, just announced two products that could dramatically change the field of DNA sequencing: a new DNA sequencer that may be able to handle a human genome in 15 minutes, and a USB thumb drive DNA sequencer that can read DNA directly from blood with no prep work.

     A nanopore is a ring of proteins, made by a bacterium, through which DNA can be threaded, like a string through a bead. In the method of DNA sequencing just debuted by Oxford Nanopore Technologies, long, intact strands of DNA are shunted through nanopores on a chip, and the electrical conductivity of each nucleic acid as it comes through the pore lets scientists tell which DNA “letter” it is—A, T, G, or C. A long strand of DNA analyzed this way, importantly, isn’t destroyed, so it can be reanalyzed, and errors introduced in processes that use chopping are also avoided. Using such basic physical laws to deduce a DNA sequence is a simple, elegant solution to a tough problem. That’s perhaps why nanopore sequencing methods have attracted some significant investment in recent years: the UN National Human Genome Research Institute had, by 2008, given $40 million to groups pursuing nanopore sequencing.

  Scientists are genuinely, if cautiously, excited by what they’ve seen of Oxford Nanopore’s work. “I think it is all credible,” Chad Nusbaum, co-director of the Genome Sequencing and Analysis Program at the Broad Institute in Cambridge, Massachusetts, told Nature News. “I would bet they are even underplaying it because they don’t want to risk overpromising.” For scientists talking about biotech, that’s pretty hopeful phrasing.

Source:http://blogs.discovermagazine.com/80beats/2012/02/22/new-mini-dna-sequencer-size-of-a-usb-stick-is-fast-and-cheap/

          http://www.forbes.com/sites/matthewherper/2012/02/17/the-next-dna-disruptor/

FDA approves anorectic Qnexa

 

         Qnexa was the first anti obesity drug approved by FDA in a decade. Last week expert advisory committee voted 20-2 in favour of Qnexa by Vivus as an antiobesity drug.This same drug was rejected by FDA in 2010 quoting the cardiac side effects and its teratogenic potential. But in a reversal it was accepted by majority of experts in the advisory committee.

    As the epidemic of obesity grows further the demand for approval of anti obesity drug was growing from all corners.In the last decade many antiobesity drugs were withdrawn from the market for their myriad no. of side effects. Even Qnexa had many issues.

      Qnexa is a combination of the anticonvulsant drug topiramate and the appetite suppressant phentermine.

    In a clinical trial involving 4,323 people, Qnexa  led to an average loss of about 10% of total body weight in the first year of use. Many users also saw improvements in blood pressure.
But the trials also found that that the drug caused a slight increase in heart rate, which can boost the odds of a heart attack or stroke. In addition, researchers detected an increased risk of birth defects — typically cleft lip — in women who became pregnant while taking the drug.

      Vivus Inc., the drug's manufacturer, addressed those concerns by proposing a tightly controlled system for prescribing Qnexa. To prevent birth defects, patients who take the drug will have to undergo monthly pregnancy testing and healthcare providers will get special training on the medication's risks and benefits. Vivus will also restrict distribution of the drug to registered pharmacies, among other measures.

Source:www.fda.gov/downloads/advisorycommittees/.../ucm218821.pdf

Morbid obesity affects cognitive function?

        Obesity is one of the important risk factors for Diabetes Mellitus , Cardiovascular diseases , microvasculopathy and many more diseases. But recently it has been found out that obesity also affects cognitive functions especially Memory.

      A research group  performed a prospective study total of 150 subjects (109 bariatric surgery patients enrolled in the Longitudinal Assessment of Bariatric Surgery project and 41 obese control subjects who had not undergone bariatric surgery). These 150 subjects completed a cognitive evaluation at baseline and at 12 weeks of follow-up. The demographic, medical, and psychosocial information was also collected to elucidate the possible mechanisms of change.

       The patients before bariatric surgery exhibited impaired performance at baseline.Same patients after 12 wks of bariatric surgery showed improved cognitive functions.The present results suggest that cognitive impairment is common in bariatric surgery patients, although these deficits might be at least partly reversible. Future studies are needed to clarify the underlying mechanisms, in particular, longitudinal studies using neuroimaging and blood markers.But this study adds one more dimension to the ill effects of obesity.

Gunstad, J., Strain, G., Devlin, M., Wing, R., Cohen, R., Paul, R., Crosby, R., & Mitchell, J. (2010). Improved memory function 12 weeks after bariatric surgery Surgery for Obesity and Related Diseases DOI: 10.1016/j.soard.2010.09.015

Source:http://www.sciencedirect.com/science/article/pii/S155072891000688X

Nilotinib as first-line therapy for chronic myeloid leukemia

        The history of treatment of chronic myeloid leukemia (CML) is divided into pre Tyrosine kinase inhibitor era and post Tyrosine kinase inhibitor era. The discovery of Imatinib revolutionized the treatment of CML and the mortality and morbidity associated with CML and chemotherapy have considerably decreased. There has been search for more tyrosine kinase (TKI)inhibitor for the treatment of CML as first line drugs. Dasatinib and Nilotinib have come up.

    It is considered that Nilotinib and Dasatinib can be used in Imatinib resistant CML. Nilotinib has been considered as 2nd line drug in the treatment till recent times. But latest trials have shown that Nilotinib is better than the legendary TKI Imatinib and Dasatinib in many aspects. It is safer,better tolerated and more efficacious drug than Imatinib and Dasatinib and clearly drug of choice in most patients with chronic phase CML.Recent article published in Indian Journal Of Cancer by Vaid A, Department of Medical Oncology,Cancer Institute,Medanta Hospital,Medicity,Gurgaon concludes that Nilotinib can be used as the first line therapy for chronic myeloid leukemia.

Source:http://www.indianjcancer.com/downloadpdf.asp?issn=0019-509X;year=2011;volume=48;issue=4;spage=438;epage=445;aulast=Vaid;type=2

Glucarpidase Approved to Lower Toxic Chemotherapy Levels in the Blood

 

          Last week, the Food and Drug Administration (FDA) approved glucarpidase (Voraxaze) to treat patients with toxic levels of the chemotherapy methotrexate (Abitrexate) in their blood.

       The kidneys usually eliminate methotrexate from the body, but patients receiving high doses of methotrexate can develop kidney failure. Glucarpidase is an enzyme that rapidly breaks down methotrexate into a nontoxic form that can be eliminated from the body more rapidly.

       “Prolonged exposure to high levels of methotrexate can result in kidney and liver damage, severe mouth sores, damage to the lining of the intestine, skin rashes, and death due to low blood counts,” explained Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a news release.
Glucarpidase is designated an orphan drug, a designation given to therapies for diseases or conditions that affect fewer than 200,000 people in the United States.

        In a clinical study of 22 patients, treatment with intravenous glucarpidase was effective in 10 patients—that is, patients’ methotrexate levels fell below a critical level within 15 minutes and stayed below that level for 8 days. (Methotrexate levels were analyzed at NCI using a sensitive and specific test.) Although not all patients experienced this result, glucarpidase eliminated 95 percent of the methotrexate in all patients.

           A separate clinical study evaluated the safety of glucarpidase in 290 patients experiencing problems clearing methotrexate from their blood. The most common side effects observed in the study were low blood pressure, headache, nausea, vomiting, flushing, and abnormal skin sensation (paresthesia).

              Most of these patients were enrolled in a compassionate-use trial run by NCI’s Cancer Therapy Evaluation Program. The trial showed that glucarpidase was well tolerated and resulted in a rapid and profound decrease in methotrexate concentrations in the blood.

Source:http://www.cancer.gov/ncicancerbulletin/012412/page9

FDA approves Korlym for patients with endogenous Cushing’s syndrome

 

    On 17th Feb 2012, Korlym (mifepristone) was approved by the U.S. Food and Drug Administration to control high blood sugar levels (hyperglycemia) in adults with endogenous Cushing’s syndrome. This drug was approved for use in patients with endogenous Cushing’s syndrome who have type 2 diabetes or glucose intolerance and are not candidates for surgery or who have not responded to prior surgery. Korlym should never be used (contraindicated) by pregnant women.

   Prior to FDA’s approval of Korlym, there were no approved medical therapies for the treatment of endogenous Cushing’s syndrome.

  Endogenous Cushing’s syndrome is a serious, debilitating and rare multisystem disorder. It is caused by the overproduction of cortisol (a steroid hormone that increases blood sugar levels) by the adrenal glands. This syndrome most commonly affects adults between the ages of 25 and 40. About 5,000 patients will be eligible for Korlym treatment, which received an orphan drug designation by the FDA in 2007.

   Korlym blocks the binding of cortisol to its receptor. It does not decrease cortisol production but reduces the effects of excess cortisol, such as high blood sugar levels.

The safety and efficacy of Korlym in patients with endogenous Cushing’s syndrome was evaluated in a clinical trial with 50 patients. A separate open-label extension of this trial is ongoing. Additional evidence supporting the agency’s approval included several safety pharmacology studies, drug-drug interaction studies and published scientific literature. Patients experienced significant improvement in blood sugar control during Korlym treatment, including some patients who had marked reductions in their insulin requirements. Improvements in clinical signs and symptoms were reported by some patients.

   The most common side effects experienced by endogenous Cushing’s syndrome patients treated with Korlym in clinical trials were nausea, fatigue, headache, arthralgia, vomiting, swelling of the extremities, dizziness and decreased appetite. Other side effects of Korlym include adrenal insufficiency, low potassium levels, vaginal bleeding and a potential for heart conduction abnormalities. Certain drugs used in combination with Korlym may increase its drug level. Health care professionals must be aware of the potential for drug-drug interactions and adjust dosing or avoid using certain drugs with Korlym. 

    Korlym should never be used by pregnant women. Although pregnancy is an extremely rare occurrence in Cushing’s syndrome patients because of the suppressive effect of excess cortisol on female reproductive function, Korlym will carry a Boxed Warning advising health care professionals and patients that the therapy will terminate a pregnancy.

    The FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is not necessary for Korlym to ensure that the benefits outweigh the risks for patients with endogenous Cushing’s syndrome. Several factors were considered in this determination including the following:

• There are no other approved medical therapies for this debilitating form of Cushing’s syndrome and very sick patients would suffer if impediments to access were imposed.
• The number of Cushing’s syndrome patients who will require treatment with Korlym is small, with an estimated 5,000 patients being eligible for treatment.
• The number of health care professionals in the United States who would potentially prescribe Korlym is very small and highly specialized. They are familiar with the risks of Korlym treatment in the endogenous Cushing’s syndrome population and frequently monitor patient status.
• The risks of Korlym treatment in the intended population can be managed through physician and patient labeling. The risks associated with Korlym will be outlined in a medication guide for patients.

The company has voluntarily proposed distributing Korlym through a central pharmacy to ensure the timely, convenient and appropriate delivery of the drug to Cushing’s patients or to the health care institutions where this therapy may be initiated. Most retail pharmacies are unlikely to keep adequate supplies of the drug for this rare condition and central distribution will give patients with Cushing’s syndrome better access to Korlym. 

Korlym is manufactured by Corcept Therapeutics of Menlo Park, Calif.

Source:http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm292462.htm