New Initiatives on OTC Internal Analgesics

Despite widespread use of products such as aspirin, acetaminophen, and ibuprofen in the general population, the tentative final monograph for OTC Internal Analgesic, Antipyretic and Antirheumatic Drug Products, issued in 1988, still has not been finalized.   The FDA has instead addressed specific concerns through separate rulemaking procedures, such as mandating the addition of an alcohol warning to the labels in 1998 followed by organ-specific warnings in 2009.

Since that time, to better educate consumers and encourage safer use of these products, the FDA has also issued several guidance documents for industry recommending further changes to the labeling, packaging and even formulation, particularly for acetaminophen-containing products.  These include a draft guidance published in 2012 allowing for alternative wording in the liver warning and, late last year, a draft guidance recommending the addition of an allergy alert that would warn users of the potential for severe skin reactions.

Just recently, the agency finalized another guidance document pertaining to OTC pediatric oral liquid acetaminophen-containing products in which it recommends that manufacturers market just a single concentration of 160 mg of acetaminophen per 5 mL dose, that the products are packaged with a dosage delivery device (preferably with a flow restrictor) and that the wording on the labeling is updated to reflect these changes.  While this, as with other FDA guidance documents, is not legally enforceable, most companies had already voluntarily implemented these recommendations following an initiative started in 2011 by the Consumer Healthcare Products Association member companies.

It should be noted however, that the FDA’s concerns are not limited to acetaminophen.  Based on a Drug Safety Communication released in July, the agency will be requesting additional changes to the Drug Facts of OTC non-aspirin NSAIDs (e.g. ibuprofen, naproxen) to strengthen the existing warnings of increased risk of heart attack and stroke.   These new warnings will recommend that those taking NSAIDs seek medical attention if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech.   

As with all FDA initiatives, it is recommended that firms monitor the agency website as well as Federal Register Notices to stay abreast of current developments.