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Types of Side Effects and FDA Regulations (cont.)

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Drug Side Effects: The FDA's Role

Before a drug can come on the market it must be approved by the FDA. The New Drug Applications (NDAs) submitted by pharmaceutical companies contain, first and foremost, clinical evidence that the drug has the therapeutic effect it's supposed to have and is safe. This proof comes from testing of the drug, first in animals and then in humans. Once the basic questions of safety and efficacy are settled, the FDA will approve the drug if it deems that its benefits outweigh its risks.

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 FDA also wants input from consumers when it comes to side effects. Beginning in July 2009, all dispensed prescriptions, 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."

Sometimes, the postmarketing 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 Approved in 1997, it was voluntarily withdrawn four years later.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.

The FDA gathers adverse event information from drug companies, as well. Drug companies are 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.



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