Why are the warnings given to both consumers and physicians? When you pick up a prescription from the pharmacy, you receive an insert that gives you information about the drug—instructions for use, proper doses, side effects, and risks. By giving patients and doctors more information on which to base judgments about good health, drug companies accept an ethical responsibility to protect their consumers. Warnings appear on the inserts in order of risk severity:

• Contraindications

• Warnings

• Precautions

• Adverse reactions In addition to these four risk categories, the FDA requires another category for selected drugs to indicate special problems that may lead to serious injury or death. These problems are displayed prominently in a box as a warning to consumers and physicians.

Based on clinical data, the black box warning alerts physicians to carefully monitor the health of patients taking these drugs.