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What Is an FDA “Black Box” Warning?

blackBoxWarningsIf you take prescription drugs, the chances are that you have seen a “black box” warning on the prescribing information. These warnings, officially known as boxed warnings and generally placed because the FDA orders them, are used to highlight the most serious potential risks and side effects associated with a prescription drug. These warnings are placed at the top of the prescribing information and are intended to limit potential serious injury from the use of a particular prescription drug. Ablack box warning is not the same as an FDA recall of drugs.

The black box warnings highlight the most serious risks associated with particular prescription drugs. If you suffered one of these dangerous side effects, you may wonder what your legal options are. To discuss your injury with an experienced drug recall lawyer, please call or email Schlichter, Bogard & Denton today.

Black Box vs. Boxed Warning

Although the two terms are used interchangeably by the FDA and by media in describing the warning, “boxed warning” is the official name of the warnings. Some doctors, scientists, and other professionals in the drug industry have objected to the use of the term “black box” because of its morbid associations.

Why the Black Box?

The boxed warnings were created in 1979 by the FDA to highlight “special problems, particularly those that may lead to death or serious injury.” Initially, the placement of the boxed warning was discretionary, but recently the rules have been amended to say that the boxed warning should always follow immediately after the drug’s basic information, including its names (trade and chemical), its dosage form and route of administration, and its initial date of US approval.

When a Black Box Is Used

According the FDA’s revised guidelines for drug manufacturers, a boxed warning should be used to highlight information that is especially important to prescribers:

  • There is a serious adverse reaction that might outweigh the potential benefit of a drug, like LevaquinReglan, or TNF blockers
  • There is a serious adverse reaction that can be prevented or reduced with appropriate patient selection, monitoring, avoiding or adding another drug, or other methods. Drugs with this type of black box warning include oral sodium phosphate, gadolinium-based contrast agents, Paxil and Prozac, or TNF blockers
  • FDA approval was conditional to certain limitations, such as being restricted for certain ages

Most often, the FDA will only put a boxed warning on a drug after certain adverse reactions have been observed. Sometimes, though, a warning might be put on a drug because certain adverse reactions have been associated with other similar drugs.

Black Box Warning vs. FDA Recall

Some people may be confused about the difference between a black box warning and an FDA recall of a dangerous or defective drug. A black box warning is primarily directed at doctors and other health care providers. It provides information that doctors should take into account when prescribing drugs to people. It is not intended to tell people that they should immediately stop taking a drug. Instead, if you learn that a drug you are taking has been given a new black box warning, you should talk to your doctor.

An FDA recall of a drug on the other hand, is directed not only at doctors, pharmacists, and other health care professionals, but at you as a person taking the drug. It often includes specific instructions about how to stop taking the drug, how to return or destroy unused product, and how to talk to your doctor about future alternative treatments.

If you would like to learn more about FDA recalls and what legal options you may have after your drug-related injury, please contact the drug recall lawyers at Schlichter, Bogard & Denton today.

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