Citation

Veltri JC, Bradford DC, Dring T, Kassner S, McElwee NE, Rollins DE. Post Marketing Surveillance 1992; 6(2): 95-106.

Copyright

(Copyright © 1992)

DOI

unavailable

PMID

unavailable

Abstract

Increased use of phenylpropanolamine (PPA) in over-the-counter (OTC) products and reports of adverse reactions have prompted manufacturers and regulators to re-evaluate the safety of this drug. We report on the findings of a retrospective study of all cases of acute human exposure to PPA (as the only ingredient in the product formulation) reported to the American Association of Poison Control Centers from 1983 to 1987. Of the 5447 cases reported, infants and children comprise about half (53.2%) of the cases. Teenage females (ages 13 to 17) account for over 18% of the exposure cases and outnumber male teenagers more than 5 to 1. One in three of the PPA exposures was intentional; typically suicide gestures or misuse. Of the 1903 intentional exposures, 26 (1.3%) patients experienced a major outcome and one patient died. Most patients in the study (93.2%) experienced either no effect or a minor effect from their exposure to PPA. Over half (62.6%) of the patients remained asymptomatic as a result of their exposure. When symptoms did develop, most were minor, they resolved rapidly and the patient returned to a pre-exposure state of health shortly after the onset of symptoms. We obtained the poison center records of 37 patients experiencing a life-threatening effect from the exposure. After careful review, only 11 cases contained information that clearly substantiated a major effect from the exposure. Most patients experiencing a major effect developed headaches, dizziness, and hypertension usually with bradycardia. Three patients experienced a very serious effect from the exposure. One patient had a cerebral hemorrhage prior to arrival at an emergency department, and one patient developed focal myocardial necrosis after receiving atropine in the emergency department for 'cardiac pauses'. The third patient was treated with atropine in the emergency department for bradycardia. She subsequently developed tachyarrhythmias leading to an anterior myocardial infarction. One patient died but the causal role of PPA was not clear because the patient received numerous drugs to treat a variety of cardiovascular complications including cardiac arrhythmias and hypotension. We found no evidence from this study of reports to poison control centers that PPA produces a high incidence of severe toxicities or otherwise poses a serious public health hazard.

Language: en

Keywords

adolescent; adult; human; child; female; male; article; major clinical study; retrospective study; headache; vertigo; poison center; atropine; hypertension; brain hemorrhage; bradycardia; phenylpropanolamine; heart muscle necrosis