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FDA Issues New Viagra Warnings

The Food and Drug Administration is cautioning doctors to carefully consider who they are handing out prescriptions to of the immensely popular impotence pill, Viagra. An estimated 6 million prescriptions have been filled since the release of Viagra, 3 million by American men. There have been 130 confirmed heart attack deaths among Americans who were taking the drug. Though it is impossible to prove that Viagra is responsible for these deaths, the FDA has required manufacturer Pfizer Inc. to add more explicit warnings to Viagra labels. The label already contained warnings that anyone taking nitrate-containing medicines should never take Viagra because the drug interaction can cause a deadly drop in blood pressure. Associated Press Medical Writer Lauran Neergaard reports that the following warnings are also being added:

"The FDA has received reports of heart attacks, sudden cardiac deaths and hypertension among Viagra users."

"Doctors should be cautious about prescribing Viagra to men who had a heart attack, stroke or life-threatening arrhythmia in the last six months, or who have significantly low blood pressure, significantly high blood pressure, a history of cardiac failure or unstable angina or the eye disease retinitis pigmentosa."

"Sexual activity itself is risky for certain men with cardiovascular disease; and for those men, Viagra obviously 'is inadvisable'."

"Doctors should consider whether temporary drops in blood pressure caused by Viagra, especially during sexual activity, would harm a heart patient before prescribing him the drug."

"The FDA has received reports of men suffering painful, prolonged erections after taking Viagra. An erection that lasts longer than four hours requires prompt medical attention."

There are some critics of Viagra who feel that these FDA warnings are not adequate in safe guarding the health of American men , siting the banning of Viagra use in Britian by men how have had heart attacks. Viagra can also impair vision, which has lead federal authorities to investigate whether Viagra may have caused the plane crash in Maryland that killed actor William Gardner Knight.

(Source: Associated Press, November 25, 1998)



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