FDA-Required Black Box Warnings
The FDA requires that pharmaceutical drugs carrying risks to patients must be accompanied by warnings. The strongest warning issued by the FDA is the black box warning. It signifies that use of the drug carries serious, even life-threatening, side effects.
Black box warnings typically include information on:
- Potential side effects
- Patients who should not take the drug (those with heart conditions, for instance)
- Recommended courses of action should side effects appear
Examples Of Black Box Warning Drugs
Notable examples of black box warnings in past years include:
- Avandia – diabetes medication linked to increased risk of heart attack for patients with underlying heart conditions
- Antidepressants – linked to increased suicidal tendencies in children and adolescents
- Antibiotics – including Cipro, Levaquin, Avelox, Noroxin and Floxin, linked to tendon ruptures
- Celebrex – warning of cardiovascular and gastrointestinal risks
- Depo-Provera – linked to dangerous loss of bone density
Black box warnings do not prohibit use and do not prevent physicians from prescribing medications. If you or a loved one has suffered due to the use of a dangerous drug, whether it came with a black box warning or not, it is important to protect your rights. You may be able to obtain compensation for your losses, including medical bills, wage loss, pain and suffering, and other hardships.
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