Sep 16 2009
Does FDA Approval Mean a Drug is Safe?
I’ve been noticing a commercial on the TV lately that I find a bit disturbing. A woman, supposedly a pharmacist, is talking about using Alli (the non-prescription version of Xenical) for weight loss and makes the statement that, “it’s FDA approved, so I know it’s safe.”
Every time I hear that line, I remember the Fen-Phen debacle of the 1990’s, and the even more recent Vioxx scandal. Both drugs were approved by the FDA, and both drugs caused untold damage to the health of the American public, killing patients and causing permanent heart and lung damage.
Fen-Phen (Redux) was approved in April 1996; even though, according to a Frontline report, the FDA knew that a soon to be released study had linked it to primary pulmonary hypertension. In spite of testimony by Dr. Stuart Rich, co-author of the International Primary Pulmonary Hypertension Study (IPPHS), and the opinions of experts on neurotoxicity, the FDA approved the use of a drug reported to have caused a fatal, incurable disease in Europe. Seventeen months later Fen-Phen was withdrawn from the market, after an article in The New England Journal of Medicine reported primary pulmonary hypertension and heart valve abnormalities in patients taking the drug.
In 1999, the FDA approved the drug Vioxx, mostly on the evidence provided by the manufacturer that the drug was safe. After 5 years, and an estimated 60,000 deaths , Merck withdrew Vioxx from the market when a 3 year study showed that patients taking the drug had an increased risk of cardiovascular complications. Later developments indicated that Merck had known about this risk since 2000, 4 years before the recall, and had purposefully hidden the information.
So - back to my question, “Does FDA approval mean a drug is safe?” The answer HAS to be, “obviously not,” considering how many patients have died from the side effects of FDA approved prescription drugs. As far as I can tell, FDA approval means only that a drug has not yet killed enough people to be considered too dangerous for human use.
