Please note: This information was current at the time of publication but now may be out of date. This handout provides a general overview and may not apply to everyone. 

brand logo

Am Fam Physician. 2010;81(3):304

See related article on FDA boxed warnings.

Reports about potentially dangerous medicines seem to always be in the news. All of this information can be confusing and overwhelming. How can you be sure that your medicines are safe to take? The U.S. Food and Drug Administration (or FDA) is the government agency that approves over-the-counter and prescription medicines. A medicine has to be tested for many years before it can be sold. Even after a medicine has been approved, the FDA continues to make sure that it is safe. If the FDA is concerned about a medicine, it will issue a warning. In some cases the FDA will decide that the medicine can no longer be sold.

What is a black box warning?

A black box warning (also called a boxed warning) is the most serious warning issued by the FDA. It is used to warn patients and doctors about serious side effects of a certain medicine.

Can I still take a medicine if it has a black box warning?

Yes. A black box warning is only to alert you and your doctor that the FDA is looking into a possible side effect. This side effect may be rare, or it may not apply to you. Talk to your doctor if you are worried about your medicine. The benefit you are getting from the medicine may be more important than the side effect.

What is a medication guide?

A medication guide is a handout that your pharmacist will give you if your medicine might cause serious side effects. Most medicines with black box warnings have a medication guide. Talk to your doctor or pharmacist if you have any questions about what you read in a medication guide.

What should I do if I hear about one of my medicines on the news?

Write down as much information about the report as you can remember. Talk to your doctor as soon as possible. Don't stop taking your medicine unless your doctor tells you to.

Where can I get accurate information about my medicines?

Your doctor or pharmacist

U.S. Food and Drug Administration

Consumer Reports

Continue Reading

More in AFP

More in PubMed

Copyright © 2010 by the American Academy of Family Physicians.

This content is owned by the AAFP. A person viewing it online may make one printout of the material and may use that printout only for his or her personal, non-commercial reference. This material may not otherwise be downloaded, copied, printed, stored, transmitted or reproduced in any medium, whether now known or later invented, except as authorized in writing by the AAFP.  See permissions for copyright questions and/or permission requests.