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The FDA Black Box

Have you heard about the other kind of black box? Not the kind in an airplane, but the kind on your prescription medications. A black box on the label or printed materials with your prescription medications can indicate the potential life threatening side effects.

Let’s keep things in perspective here — if transportation was labeled like medication, lots of methods of travel would earn black boxes. And NOT taking a black box medication may be even more deadly than taking it. Avandia (a diabetes medication) received a black box warning in May 2007 for slightly raising a person’s chances of developing heart disease. However, would NOT taking your Avandia make your diabetes go out of control and seriously endanger your health?

If your doctor has prescribed a black box medication — or a medication has received a black box warning since you were told to take it — you should talk to your doctor.

  • Ask your doctor if the benefits of the medication outweigh the risks of side effects.
  • Ask why your doctor chose that specific medication as opposed to another one.
  • Ask if there are any similar medications with different or less severe or less dangerous side effects.
  • Bring a list of all your other prescription medications and vitamins and supplements you may take. This will help your doctor be aware of any potentially dangerous side effects or drug combinations.

How do you know if you are taking a black box drug? The warning doesn’t usually appear right on the bottle. Look for the printed materials that came with your prescription — the warning will appear in a black box (a thick black border around the text). The black box may only warn doctors and patients about certain situations when the drug can be potentially dangerous. A black box warning may not mean a drug is unsafe across the board.

Don’t panic. Don’t stop your medications if you do have a black box warning. Talk to your doctor about your other medication options and the benefits and risks of a particular prescription medication.