FDA proposes labeling changes

September 1, 2000

Pharmaceutical Representative

The Food and Drug Administration has issued a draft guidance for changes to the adverse reactions section of prescription drugs. The document, which is available through the agency's Web site, suggests that the adverse events section be limited to information that can be helpful in treating, monitoring and advising patients.

The Food and Drug Administration has issued a draft guidance for changes to the adverse reactions section of prescription drugs. The document, which is available through the agency's Web site, suggests that the adverse events section be limited to information that can be helpful in treating, monitoring and advising patients.

According to the FDA, adverse event labeling should be presented in tables with accompanying text and should contain listings of:


•Â Serious and important adverse reactions described in other labeling sections.


•Â Most commonly occurring adverse reactions.


•Â Adverse reactions most frequently resulting in clinical intervention, for example, discontinuation of the drug, dosage adjustment or need for additional medication to treat adverse reaction.

The guidance also suggests that, "Long and exhaustive lists of every reported adverse event, including those that are infrequent or minor, should be avoided." Instead, the agency suggests that selection or exclusion of adverse events for presentation in the adverse reactions section should be "based on factors such as frequency of reporting, whether the adverse reaction rate for the drug exceeds the placebo rate, extent of dose response, extent to which the reaction is consistent with the pharmacology of the drug, timing of the reaction relative to time of drug exposure and whether the adverse reaction is known to be caused by related drugs."

The agency also plans to limit the use of nonspecific terms like "well-tolerated" to characterize overall adverse reactions experience. "Use of the terms 'rare,' 'infrequent' and 'frequent' should generally be avoided," the agency said. PR

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