Drug Side Effects Explained
Drug Side Effects: The FDA's Role continued...
The FDA also wants input from consumers when it comes to side effects. All prescription drugs, and many OTC products, must be labeled with a toll-free number maintained by the agency for the purpose of reporting side effects with drugs, called "adverse events." You can report possible new but severe side-effects through calling MedWatch at 1-800-FDA-1088 or through the FDA web site: www.fda.gov/Safety/MedWatch/HowToReport/default.htm.
Sometimes, the post-marketing information coming in to the FDA is so disturbing that it results in a drug coming off the market. Baycol, which lowers cholesterol, was strongly linked to a potentially fatal breakdown of muscle tissue. Approved in 1997, it was voluntarily withdrawn four years later. The anti-inflammatory drug Duract spent just one year on the market. Approved as a strictly short-term use product, the FDA found serious liver problems with people taking the drug for longer than what was recommended.
Drug companies are also required to report adverse events to the FDA, and failure to do so can lead to prosecution. In 1985, employees of two drug companies were fined and/or sentenced to community service for not reporting adverse events involving the blood pressure drug Selacryn and arthritis drug Oraflex. Both products were pulled from the market.
Drug Side Effects: Surprising Results
But not every side effect is a bad one. Some are downright welcome. Take finasteride. Introduced in 1992 to treat noncancerous enlargement of the prostate gland, it was found to regrow hair (and is marketed for that purpose under the name Propecia). Today, millions of men use a low dose of finasteride to treat male pattern baldness. Similarly, minoxidil, originally marketed as an oral tablet for high blood pressure, was found to grow hair in those using it. Today, as a topical lotion or foam, it is a popular over-the-counter remedy for baldness.