Print this page    •   Back to Web version of article

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 www.fda.gov and fill out form 3500. It is confidential and may also be printed and either mailed or faxed (1-800-FDA-0178).


Back to the Project Inform Perspective April 2007 contents page.




This article was provided by Project Inform. It is a part of the publication Project Inform Perspective. You can find this article online by typing this address into your Web browser:
http://www.thebody.com/content/art43066.html

General Disclaimer: TheBody.com is designed for educational purposes only and is not engaged in rendering medical advice or professional services. The information provided through TheBody.com should not be used for diagnosing or treating a health problem or a disease. It is not a substitute for professional care. If you have or suspect you may have a health problem, consult your health care provider.