Phil B.FontanarosaMD, Deputy EditorIndividualAuthorMargaret A.WinkerMD, Deputy EditorIndividualAuthorStephen J.LurieMD, PhD, Fishbein FellowIndividualAuthor
In Reply: The FDA's adverse event reporting
system is intended to identify safety signals. Pfizer, the FDA, and regulatory
authorities in more than 80 countries where sildenafil has been approved closely
monitor the postmarketing experience. With more than 10 million prescriptions
having been filled by more than 5 million men (representing more than 100
million tablets dispensed), there is a substantial body of evidence that sildenafil
is safe when used in accordance with the product label.
Kloner RA, Siegel RL. Sildenafil and Nonnitrate Antihypertensive Medications—Reply. JAMA. 2000;283(2):201–202. doi:10-1001/pubs.JAMA-ISSN-0098-7484-283-2-jbk0112
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