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The Food and Drug Administration (FDA) takes a comprehensive approach to making information on potential drug risks available to the public, says Paul Seligman, M.D., M.P.H., Associate Director of Safety Policy and Communication in FDA's Center for Drug Evaluation and Research.
When FDA receives information about the safety of a drug or other problems such as medication errors, the agency evaluates how best to communicate this information—depending on how serious and frequent the problem is, and whether evidence shows that the reported problem is actually related to the drug.
"Providing timely information can help health care professionals and patients make better treatment choices," Seligman says. "We encourage consumers to talk with their health care professionals and ask questions about the benefits and risks of the drugs they are taking."
There are many different types of communications that inform the public about the safe use of medicines. So how can you find information about a drug you are taking, whether it's a new warning, an early communication about an ongoing safety review, or other FDA actions?
Here are some of the resources that can help you stay informed.
This index features an alphabetical listing of drugs that have been the subject of a Public Health Advisory, a Healthcare Professional Information sheet, an Early Communication About an Ongoing Safety Issue, or other important information. www.fda.gov/cder/drug/drugsafety/DrugIndex.htm
These advisories contain important drug safety information and recommendations of actions that can be taken to avoid or minimize harm from a drug. You can access a listing of FDA Public Health Advisories by date at www.fda.gov/cder/news/pubpress.htm
MedWatch provides timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts contain information that may affect choices and treatment using these products. MedWatch is also a venue for reporting any unexpected side effects (adverse events) of these products. You can sign up to receive MedWatch safety alerts by e-mail. www.fda.gov/medwatch/
Developed with the National Library of Medicine, DailyMed is a Web site that gives physicians and patients electronic access to FDA-approved drug labels. http://dailymed.nlm.nih.gov
This resource allows you to search for information about FDA approved brand name and generic drugs and therapeutic biological products. These are proteins derived from living material (such as cells or tissues) used to treat or cure disease. You can search in many ways, including by drug name and active ingredient. www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Podcasting is a method of publishing and syndicating audio broadcasts through the Internet. These podcasts provide emerging safety information about drugs in conjunction with the release of Public Health Advisories. www.fda.gov/cder/drug/podcast/default.htm
Aimed at health care professionals, this quarterly publication is designed to enhance communication of safety information after a drug is marketed. The newsletter raises awareness of adverse events and stimulates reporting of adverse events. www.fda.gov/cder/dsn/default.htm
FDA offers timely and easy-to-read articles on product approvals, safety warnings, and other health information. Articles cover all FDA-regulated products, including human drugs, drugs and feed for animals, medical devices, vaccines, blood, food, dietary supplements, and cosmetics. To find these articles, visit the Web page at www.fda.gov/consumer/default.htm
You can also sign up to receive notices of new consumer articles at www.fda.gov/consumer/consumerenews.html
FDA provides information on drug products that have been recalled due to manufacturing problems and/or safety concerns. In addition to information released to the public by a manufacturer using the normal media channels, FDA posts information about these recalled drug products at www.fda.gov/opacom/7alerts.html
You can also sign up to receive e-mail notices of product recalls.
This is a televised series for health care professionals, carried on satellite broadcast networks aimed at hospitals and other medical facilities across the country. It features safety information on new drugs, biologics, and medical devices.
Protect Your Health
Joint FDA/WebMD resource
Consumer Education: What You Need to Know to Use Medicine Safely
Medicines in My Home
A Guide to Drug Safety Terms at FDA
FDA 101: Medication Errors
Managing Drug Safety Issues
Q and A with Paul Seligman, M.D., M.P.H.
FDA Launches Drug Safety Newsletter
Strengthening Drug Safety
Updated: February 18, 2009