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Previous Volume 344:1094-1095 April 5, 2001 Number 14 Next

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To the Editor: 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)¹ 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. Kernan et al. report an increased risk of hemorrhagic stroke only in association with . . . [Full Text of this Article]

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