In an analysis piece for Forbes, journalist Ed Silverman writes that the U.S. Food and Drug Administration may have used a flawed statistical model in its evaluation of the bleeding risks for the drug Pradaxa.
Pradaxa is a blood thinner, used to prevent blood clots and strokes in patients with atrial fibrillation. The Institute for Safe Medicine Practices has linked the drug to more than 500 deaths and ...
continue reading...Patients who go on low-dose daily aspirin appear to be at lower risk of developing potentially deadly blood clots, according to a story in U.S. News and World Report.
The story concerns a study in which researchers combined the results of a small study with those of a similar trial, so that the combined data was large enough to test for trends. The combined study indicated that daily aspirin could ...
continue reading...A story in The Scientist magazine says some medical professionals are concerned about health risks attendant with the U.S. Food and Drug Administration’s heavy reliance on the fast-track review process for new medications.
The Scientist cites an article in the Journal of the American Medical Association, which states that the FDA fast-tracked nearly half of all the 35 drugs it reviewed in 2011.
Among them was the blood thinner dabigatran, sold ...
continue reading...According to Reuters, the U.S. Food and Drug Administration has set March 17 as the deadline for deciding whether to approve blood thinner Eliquis for patients with atrial fibrillation.
The agency declined to approve the drug in June, requesting that manufacturers Bristol-Myers Squibb Co and Pfizer Inc. provide more information on a pivotal clinical trial of the medicine, which is designed to reduce the risk of stroke caused by blood ...
continue reading...New research indicates that people who stop taking the blood thinner warfarin over concerns about gastrointestinal bleeding raise their risk of blood clots and death if they remain off the drug, according to U.S. News and World Report.
Warfarin makes it harder for clots to form and block the blood stream, and is prescribed to ward off conditions such as stroke that are caused by blood clots. It also raises ...
continue reading...An article in the Journal of the American Medical Association alleges that an effort by the U.S. Food and Drug Administration to speed approval of new medicines has led to drugs making it onto the market without proper safety analysis.
The article specifically mentions the blood thinner Pradaxa, the Wall Street Journal reports.
The JAMA article is by Thomas J. Moore, who has written two books on drug safety and is ...
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