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Consumer Care

Consumer Care. Bayer Corporation Consumer Care Division September 19, 2002 Allen H. Heller, MD Vice President, Global Research & Development. Bayer OTC Analgesic Products. Acetaminophen Containing - Multi-symptom Combinations Alka-Seltzer  Plus -- Cough/Cold/Allergy Midol  -- Menstrual

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Consumer Care

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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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