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HRG OTC PROMETHAZINE PETITION: "ASSOCIATION" WITH SUDDEN INFANT DEATH

Executive Summary

HRG OTC PROMETHAZINE PETITION: "ASSOCIATION" WITH SUDDEN INFANT DEATH was alleged by the Health Research Group in support of prescription-only marketing of the cough/cold ingredient. "Use of promethazine syrups at therapeutic doses has been highly significantly associated with Sudden Infant Death Syndrome (SIDS) in one study, and with an increase in infant sleep apneas, in another," the citizen's petition asserts. The joint petition from HRG and the University of Maryland's Sudden Infant Death Syndrome Institute was submitted to FDA on Dec. 14. The petition requests an "immediate ban on all OTC use of products containing promethazine HCI, including [Wyeth-Ayerst's] Phenergan DM and Phenergan VC." Wyeth-Ayerst received approval for OTC marketing of its promethazine products, Phenergan DM and Phenergan VC, on Aug. 11 via supplemental NDAs ("The Pink Sheet" Oct. 24, T&G-1). One day later, FDA published the tentative final monograph for combination cough/cold products, which allowed promethazine-based combination products to be marketed OTC ("The Pink Sheet" Aug. 15, p. 6). The petition also cites a study in which "oral promethazine at therapeutic doses induced ...severe behavioral change" in hyperactive young children, as well as a sedation study in middle-aged patients where 8% of the patients "developed dyskinetic reactions." The filing adds that "in an elderly population, the adverse reaction rate could be expected to be higher." Beyond requesting that FDA prevent promethazine-containing products from being made available OTC, the petition also asks the agency to change the physician labeling to include a bold, boxed warning stating: "This product contains promethazine hydrochloride, a drug which should not be used by children under the age of two years, or by pregnant or breast feeding women because safety is not established in these patients, and because promethazine is associated with Sudden Infant Death Syndrome (SIDS) and infant respiratory depression." Also, the petition asserts that a mandatory patient package insert should be required. The insert, according to HRG, ought to caution that "a modified dosage schedule should be used in the elderly patient, and that the product should not be used by children under the age of two years, or by pregnant or breast feeding women." HRG would also like to severely limit the availability of promethazine products via prescription. The filing asks that promethazine's use as "an antihistamine in prescription cough/cold analgesic-antipyretic compounds" be prohibited through the "removal from prescription availability of promethazine containing products marketed specifically for this purpose, including Phenergan with codeine, Phenergan DM, Phenergan VC, and Phenergan VC with codeine." Wyeth-Ayerst, in a prepared response to the petition, stated that FDA has "carefully reviewed all data prior to publishing the tentative final monograph and we're satisfied [that] the products are suitable for OTC sale. In their 35 years of marketing, these syrups have been remarkably problem-free."
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