Drug Side Effects Explained
Drug Side Effects: The FDA's Role continued...
Still, sometimes not everything is known about a drug’s side effects until after it enters the marketplace and more people start using it. That’s where MedWatch comes in. The FDA’s post-marketing surveillance program seeks voluntary input, mainly from health care professionals, on adverse effects they may be seeing in ''the real world.'' Sometimes these reports are numerous and/or serious enough for the FDA to take regulatory action, such as adding warnings to a drug’s label. One example of that involves the psoriasis drug Raptiva. The FDA required that the drug carry the agency's strongest warning, known as a black box warning, after it received reports of brain infections and meningitis in patients taking the drug. The drug was later withdrawn from the market.
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 Approved in 1997, it was voluntarily withdrawn four years later.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.