New Viagra Warnings Issued By FDA

26 November 1998

The US Food and Drug Administration has issued new warnings aboutPfizer's Viagra (sildenafil) to doctors, recommending they exercise caution in prescribing it to groups of men such as those who have had a recent heart attack and those with high blood pressure.

The warnings come after the deaths of 130 Americans were associated with the drug, launched onto the market last spring (Marketletters passim). However, the FDA stresses that no proof links the deaths with Viagra, especially as heart disease kills hundreds of Americans every day.

The FDA also advised doctors that Pfizer has made the contraindication warnings on the label for the impotence treatment more explicit. The label now warns doctors that the FDA has received reports of heart and blood pressure problems and that caution should be exercised in prescribing to those with a history of heart or cardiovascular problems or the eye disease retinitis pigmentosa, as the safety of Viagra for men with these conditions is unknown. The new label also warns doctors to consider dangerous drops in blood pressure and priapism before prescribing.

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