[Skip to Navigation]
Citations 0
January 12, 2000

Sildenafil and Nonnitrate Antihypertensive Medications—Reply

Author Affiliations

Phil B.FontanarosaMD, Deputy EditorIndividualAuthorMargaret A.WinkerMD, Deputy EditorIndividualAuthorStephen J.LurieMD, PhD, Fishbein FellowIndividualAuthor

JAMA. 2000;283(2):201-202. doi:10-1001/pubs.JAMA-ISSN-0098-7484-283-2-jbk0112

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.