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What is a 'black box' warning?

Every drug -- whether it's something as simple as an aspirin for a headache or something as complicated as one of the new biologic medications for certain chronic conditions -- comes with its own risks.

Some of those risks, however, are certainly greater than others. Drugs that carry the greatest risks are given a "black box" warning.

Black box warnings are the strictest label that the Food and Drug Administration (FDA) can impose on a prescription drug. Physically, it looks very much like it sounds: a black box surrounds the list of severe or deadly adverse reactions that patients can experience while taking the drug. Black box warnings can be imposed at any point after a drug hits the market -- which means that patients may already be taking the drug when a serious adverse reaction is discovered.

Black box warnings can be used to alert patients that the drug has possibly deadly interactions with another drug and warn them about dangerous dosages. However, most commonly, it's there to warn users that the drug can cause life-threatening complications.

For example, some black box warnings include:

  • Anti-seizure medications like Lamictal and Topamax, which are also used to control chronic daily migraines, can cause a life-threatening skin reaction known as Stevens-Johnson Syndrome (SJS), particularly among children.
  • A drug called Linzess, designed to treat constipation in adults, can be fatal if given to children under six years of age.
  • Tygacil, a type of antibiotic in the tetracycline class, increases the risk of death to the patient and is, therefore, considered a "last resort" antibiotic that is to be used only when other options have failed.

It's important to understand that just because a drug has a black box warning doesn't mean that every patient will develop those complications. However, patients and caregivers have a right to know the risk they are taking when they take a certain drug.

When black box warnings are not communicated to patients by their doctors or pharmacists -- patients can end up taking a drug without knowing the potential danger. In other cases, drug companies have hidden the dangers of a drug for longer than they should have because they don't want doctors to stop prescribing it. In both those cases, injured patients or their families may have a right to recover for their damages.

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