What Is An FDA Black Box Warning?
A black box warning is the strongest warning that a medication can carry and still remain on the market. Certain medications are safe for some patients and severely dangerous for others. When a given drug has been shown to cause harmful side effects, the Food and Drug Administration (FDA) will issue a “black box warning” for the product.
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The Black Box
This warning is named after the bold black border drawn around the text. The border is created to draw attention to the warning, and to differentiate it from other labeling information. A black box warning must be printed on all materials, both inside the packaging and on the documents received by doctors who will prescribe the medication.
A black box warning must include any important information about:
- Safety concerns
- Serious side effects
- Life-threatening risks
How a Drug Receives This Warning
A drug is issued a black box warning when studies performed on the drug suggest that it may cause dangerous side effects. Unfortunately, many of these warnings are issued after the drug has been on the market and used by countless consumers.
If your medication has received a black box warning, you should discuss with your doctor the potential side effects and any alternatives. Then decide whether the benefit of the drug is worth the potentially harmful consequences.
If you or someone you love has suffered adverse side effects from a defective drug, or your medication has been recalled, please contact the knowledgeable defective drug attorneys at Schlichter, Bogard & Denton. We serve clients nationwide.