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Reporting Adverse Medication Events to the FDA

April 2007

One of the most important details when taking a new medication is how safe it is. The US Food & Drug Administration (FDA) collects this information in many different ways, including from individuals who use the medicines or medical products. By doing so, the FDA can identify possible problems, especially when medicines enter expanded access programs (EAPs) and reach more people.

As three new anti-HIV drugs enter EAPs -- etravirine (TMC-125), raltegravir (MK-0518) and maraviroc -- it's important for readers to know that they can report problems to the FDA. This voluntary program is known as MedWatch and can be used by anyone. It covers medicines, medical devices, special nutritional and tissue-based products and cosmetics.

Any adverse events can be reported, especially serious ones. These include ones that are life-threatening, require a hospital visit, require intervention to prevent permanent impairment or damage, birth defects and, of course, death. Issues such as quality, safety, performance, product use errors, and packaging problems can be reported, even if you're not certain the product caused the adverse event or if you don't have all the details.

To report by phone, call 1-800-FDA-1088. For adverse events with a vaccine, call 1-800-822-7967. To report online, go to and fill out form 3500. It is confidential and may also be printed and either mailed or faxed (1-800-FDA-0178).

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