Understanding the Black Box Label on Your Meds

Whether by need or by choice, many Americans look for health in a bottle.  According to the Centers for Disease Prevention and Control (CDC), in any given month during the three-year period from 2005 to 2008, almost 50 percent of the population took at least one prescription drug. With the steady increase in prescription drug use since that time, the percentage has risen alarmingly.

The U.S. Food and Drug Administration (FDA) is a federal agency charged with safeguarding public health through the regulation of food, drugs, medical devices and other products affecting the physical well-being of Americans.

As part of regulating pharmaceuticals, the FDA oversees the labels affixed to prescription drug containers.  A boxed warning or black box is the strongest alert or warning used by the FDA. It indicates that a drug meets one of the following criteria:

  • Given the possibility of a serious, potentially fatal adverse reaction, the benefit of the drug must be weighed against the risk
  • The risk of a serious drug reaction can be reduced or prevented by proper use
  • The FDA concluded that the drug is safe only in restricted use

In 2007, the FDA announced a boxed warning on the thiazolidinedione category of drugs, including Avandia, Actos, and Duetact. While the 2007 warning addressed the risk of heart failure, the FDA added additional warnings about bladder cancer from Actos in 2011.

Physicians and patients should discuss side effects of newly prescribed medications, although that does not always happen. If the best health outcome for you comes from a bottle, make sure you read the label and understand your risks. If you are seriously injured as a result of prescription drug side effects, you may wish to contact a personal injury attorney at our office for more information about your right to compensation.