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What Is A Black Box Warning? | Dangerous Prescription Drug Attorney

A black box warning is the strongest warning that the FDA can require on the packaging of a prescription drug. Named for the thin black line that surrounds the text of the warning, a black label warning outlines a drug’s possible side effects and issues as determined through medical studies. In many cases, a boxed warning could contain information about very serious or even life-threatening adverse drug effects. Some black box warnings appear in the packaging of a prescription drug as soon as the drug is released, while in other cases, a black label warning may be added to a drug after adverse effects are reported and more research is conducted regarding the side effects.

In recent years, the FDA has required a number of pharmaceutical companies to add new black box warnings to their drug packaging – often times after a number of reports that certain drugs were dangerous. For example, in 2009, the FDA issued a mandatory black box warning on 24 different antidepressant drugs stating that the medication could increase the chances of suicide in people aged 18-24, especially in the first few months of use. In 2007, the FDA issued a black box warning for the diabetes drugs Avandia and Actos after the drugs were linked with congestive heart failure in a number of patients.

Patients should read black box labels thoroughly and ask their doctors any questions they may have regarding what they read. However, patients should also know that black box label warnings do not necessarily cover all of the side effects and adverse effects of the drug you are taking. If you suffer from an adverse effect connected with your medication, report it to your doctor immediately.

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