Phenylpropanolamine and Hemorrhagic Stroke

Abstract

The request by the Food and drug Administration (FDA) for the voluntary withdrawal of all products containing phenylpropanolamine on the basis of the data of Kernan et al (Dec. 21 issue) is excessive. Although the study was rigorously designed and the data compelling with respect to the risk of hemorrhagic stroke with this agent, it does not provide justification for the withdrawal of all products containing phenylpropanolamine, particularly decongestant preparations that have been used safely in prescription and nonprescription products for many years.