FDA Nixes Ibuprofen Products From Proposed Rule on OTC Monograph

The US Food and Drug Administration (FDA) announced Friday a partial withdrawal of a 2002 proposed rule on internal analgesic, antipyretic and antirheumatic (IAAA) over-the-counter (OTC) drugs over changes in the agency’s understanding of risks linked to ibuprofen.

The rule, as initially proposed, would have amended FDA’s tentative final monograph (TFM) for IAAA drug products to include ibuprofen “as a generally recognized as safe and effective (GRASE) analgesic/antipyretic active ingredient for OTC use,” FDA said in a notice.

However, safety issues associated with ibuprofen use were raised during 2014 FDA advisory committee meetings, including “increased risk of heart attack and stroke that may be worsened with using too much” of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, or “using NSAIDs for longer than recommended,” the agency added.

These issues caused FDA to withdraw the 2002 proposed amendments to 21 CFR part 343.

The partial withdrawal, however, will not affect the marketing of ibuprofen products covered under FDA-approved new drug applications or abbreviated new drug applications.

Most other IAAA drug products are marketed under the TFM, according to the 2017 FDA labeling guidance documents on OTC products containing aspirin and acetaminophen.