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Bayer's Position on Acetaminophen Combination Products: Safety and Labeling Guidelines

This document outlines Bayer Corporation's stance on the safety and efficacy of acetaminophen-containing multi-symptom combination products, including Alka-Seltzer Plus, Midol, Vanquish, and Bayer Aspirin. It emphasizes the low risk of hepatic adverse outcomes associated with these products based on extensive adverse event reports. Bayer advocates for clear labeling to educate consumers about the risks of simultaneous use of acetaminophen products, while arguing that further regulatory actions beyond labeling are unnecessary, as the overall safety profile of these combination analgesics remains favorable.

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Bayer's Position on Acetaminophen Combination Products: Safety and Labeling Guidelines

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  1. Consumer Care Bayer CorporationConsumer Care DivisionSeptember 19, 2002Allen H. Heller, MDVice President, Global Research & Development

  2. Bayer OTC Analgesic Products • Acetaminophen Containing - Multi-symptom Combinations • Alka-Seltzer  Plus -- Cough/Cold/Allergy • Midol -- Menstrual • Acetaminophen Containing - Analgesic Combination • Vanquish • Non-Acetaminophen Containing - General Analgesics • Bayer Aspirin • Aleve (Naproxen Sodium) • Midol Cramp (Ibuprofen)

  3. Combination Products • Consumer benefit • - multi-symptom relief • - convenience • Not associated with significant adverse reports (including liver failure) • Voluntarily labeled

  4. Bayer Position • Acknowledges importance of clear, concise, ingredient specific labeling • Supports (and has adopted) CHPA proposed labeling regarding risk of simultaneous APAP use • Submits that additional regulatory intervention beyond labeling on combination products is not warranted

  5. Combination Product Safety • FDA spontaneous report database suggests low hepatic risk potential of combination products • Bayer has received no reports of adverse hepatic (serious or non-serious) outcomes and no deaths with any of its acetaminophen containing products • Adverse Event Reports 1995 - March 2001 • Total Reports 1,758 • % Serious 1.0% Where product category was specified (227 cases), 53.7% involved a prescription narcotic analgesic combination product and 33.5% involved a single ingredient acetaminophen product, while less than 12% involved an OTC combination product.

  6. Combination product use pattern (short term, other ingredients, packaging) enhances benefit risk relationship • Enhanced warning (CHPA) will further educate consumers regarding the potential risk of simultaneous use of multiple products containing APAP Combination Product Safety (Continued)

  7. Analgesic Labeling • Labeling must be based on substantial evidence • Individual ingredients should be regulated based on their unique pharmacology/toxicology • Overall safety risk is low and does not differ appreciably across the ingredients

  8. Switching Argument • Estimates presented to this Committee regarding excess injury due to potential switching are biased and flawed • Based on data from prescription use that are not relevant to OTC use • Contradicts recent findings that demonstrate comparable GI risks across OTC analgesic ingredients • Considers only the hepatic risk of APAP and does not consider other potential risk factors associated with APAP

  9. Conclusion • All OTC analgesic ingredients are safe and effective • Necessity for regulatory action with APAP should be independent of other ingredients and based on sound scientific principles • CHPA-proposed labeling on simultaneous use of acetaminophen-containing products is appropriate • Further regulatory interventions for APAP-containing combination products are not warranted

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