The most serious side-effects warning that the FDA requires will stay on Chantix for now. After a full day of listening to new evidence about the drug, 2 advisory committees to the FDA voted overwhelmingly to keep the Black Box warning about the neuropsychiatric side effects of Pfizer’s smoking-cessation pill. In a joint meeting on October 16 of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, 11 out of 18 members voted to keep the boxed warning for Chantix (varenicline tartrate tablets), pending results of a clinical trial expected to be completed in the fall…

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The FDA wants to know what you think about a disease before they start approving drugs. Bravo – it’s about time! The Patient-Focused Drug Development Initiative is meant to enhance the FDA’s assessment of benefit-risk in their regulatory decision-making and help them better understand how patients view the severity of a disease, its impact on daily life, the types of treatment benefit that matter most and the adequacy of available therapies. (The full set of performance commitments is available on the FDA Web site.) The Search for ‘Female Viagra’ Female Sexual Interest/Arousal Disorder (FSI/AD) is the new name for “Not tonight,…

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Thalidomide is one of the horror stories of pregnancy. A drug given to women in pregnancy and purported to be completely safe. In fact, the scientific studies that approval was based on were sketchy. The company was, at best, cavalier in it’s concern for safety. It was banned world wide in 1962. But as early as 1964 doctors were finding new uses for it. Every drug has side effects, but this story shows that thalidomide is still out there and still creating birth defects. via New York Times.

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The latest question before the FDA concerns the use of ARBs (angiotensin receptor blockers), when used primarily to manage hypertension. Dr. Thomas Marciniak, FDA official, says the use of ARB-drugs seem to be linked somehow to an increase in the risk of lung cancer. Other FDA officials disagree and don’t want to promote/demand any further clinical or epidemiological studies. What makes this issue interesting? Marciniak works for the FDA and has brought his concerns to the public, whose internal discussions are usually kept tight to the vest within the Agency. Literally millions of hypertensive patients are currently take ARBs. Sales of ARBs were $7.6 billion in the US last year. The FDA seems…

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