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What does a black box warning on my medication mean?

On Behalf of | Apr 1, 2020 | Medical Malpractice, Medication Errors |

All medications come with a little bit of risk to the patient — but some drugs are inherently harder on the human system than others and vastly more dangerous to take because of their potential for serious or deadly side-effects.

The Food and Drug Administration (FDA) labels these kinds of drugs with a warning inside a literal black box. It’s the strongest warning that a drug can carry regarding its dangers and still be legal to use in the United States.

What’s the point of a black box warning? They accomplish several goals:

  • There are thousands of drugs out there on the market. A black box warning alerts you and your physician that this particular drug is among the most dangerous so that neither of you remain unaware of the risks associated with taking it.
  • It makes it easier to weigh those potential risks against the potential benefits of taking the drug. An informed decision about what drugs you will take isn’t possible unless you’re aware of both the pluses and minuses of a drug.
  • It clearly explains how the drug can be used more safely. For example, some drugs can never safely be used by pregnant women. Other drugs, including some antidepressants, pose a bigger danger to children and teens than they do adults.

Unfortunately, the process of getting a black box label on a drug is laborious and time-intensive. Drug companies sometimes deliberately “bury” negative information about a drug so that the FDA won’t put a black box warning on a certain medication that’s profitable. Doctors also sometimes overlook them and prescribe them when they’re unnecessary.

If you are injured by a prescription medication, find out how an experienced attorney can help you obtain the financial resources you need moving forward.