An FDA advisory panel today recommended that recently controversial drugs Celebrex, Vioxx, and Bextra remain on the market, albeit with some restrictions. The panel acknowledged that the drugs can cause heart attacks and strokes, but said the benefits the painkillers provide outweighs the risks. The suggested limitations on the drugs include no direct to consumer marketing and narrowing the class of patients who are eligible to receive the drugs.
The FDA doesn't have to accept the advisory panel's recommendations. If you're them, what do you do? If you're the pharmaceutical companies, how do you restore faith in this tarnished class of drugs?
Related Stories: | Topics:Work/Life, healthcare + medicine, Food and Drug Administration, Bextra, Celebrex, Vioxx, Heart Attacks |
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Recent Comments | 4 Total
February 18, 2005 at 6:17pm by Aleah
Pfizer is threatening to let go of a percentage of their sales/marketing department. They were hit pretty hard and I believe the industry is finally facing a shake-down, now that the magnifying glass is over pharmaceuticals.
February 18, 2005 at 6:18pm by Aleah
Pfizer is threatening to let go of a percentage of their sales/marketing department. They were hit pretty hard and I believe the industry is finally facing a shake-down, now that the magnifying glass is over pharmaceutical monoliths.
February 19, 2005 at 7:10pm by Andrew Shepard
From Wikipedia http://en.wikipedia.org/wiki/Celebrex:
On December 17, 2004, Pfizer announced that in a National Cancer Institute study, those taking between 400 and 800 milligrams of celecoxib per day had respectively 2.5 and 3.4 times increased risk of a heart attack or stroke than those taking placebo. However, in another trial, there was no increased risk. Furthermore, these dosages of celecoxib are higher than the FDA-approved dose range of 100-400mg.
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Strategy for companies? Tell them the above fact.
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