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List of Black Box Warnings

The Food and Drug Administration, (FDA), continually updates it list of "black box warnings" (BBW), in which doctors report adverse side effects or serious problems patients have with a medication. If several people have the same problem with the same medication, it triggers a review. The FDA does not consider these medications unsafe, but rather wants to inform the public about potential serious side effects.

  1. The Black Box

    • Look for warnings on your medication.

      On the box or package of a drug. there may be an outline of a black box that warns about serious side effects. By law, the FDA by law must inform consumers if there have been side effects or complications from a particular drug. The FDA considers the black box a strong warning.

      If you are taking a medication with a black box on the label, discuss with your health care provider whether you are at risk by taking this medication. Hospitals and pharmacies have programs that continually update the BBW list to ensure patient safety. The BBW is considered enough of a safety precaution that it protects the manufacturer from liability.

    FDA Actions to Ensure Public Safety

    • The FDA can require labeling changes such as having the manufacturer add new information to the package insert. Boxed warnings are for the most serious adverse reactions. This warning is required to be on the box in a very visible place to ensure safe use. The FDA can require that a manufacturer conduct product recalls and withdrawals. This might also result in permanent removal of the medication from the market. The other action that the FDA can take is to provide medical and safety alerts to health care professionals and media and trade organizations.

    Cautionary Tips

    • Know what you are taking and the proper way to take it.

      "The Annals of Pharmacotherapy" concluded on their site, www.theannals.com, that all "clinicians should consult multiple drug resources to maximize the potential for detecting a potentially severe drug interaction". For your own safety and information, research your medications on sites such as formularyproductions.com.

      If a medication on the list is in bold type, it could contain a BBW. Discuss each new medication with your health-care provider to ensure your own safety and ask about Black Box Warnings.

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