Pfizer's Viagra Requires Care in Prescribing, Heart Groups Say
Washington, Dec. 31 (Bloomberg) -- Doctors should carefully evaluate heart patients before prescribing Pfizer Inc.'s top- selling impotence drug Viagra, two medical associations said in formal recommendations to doctors.
The American Heart Association and American College of Cardiology guidelines will appear in the two organizations' respective journals in January. The strongest recommendation the two groups make is that patients taking heart medicines known as nitrates should not be prescribed Viagra -- a risk already well- known and listed in the Pfizer drug's label.
The recommendations also caution against prescribing Viagra to patients who have restricted blood flow to the heart, congestive heart failure, or who are taking several blood pressure medications or drugs that might prolong Viagra's action in the body.
While the recommendations are in line with precautions already publicized by the U.S. Food and Drug Administration and New York-based Pfizer, they mark the first formal expert guidance directed at doctors treating heart patients, the groups said.
''We formulated these recommendations to appropriately caution, and not to unduly alarm, physicians who may wish to prescribe the drug to their patients with cardiovascular disease,'' said Melvin Cheitlin, an emeritus professor from the University of California at San Francisco.
Last month, the FDA added new warnings to ensure the safe use of Viagra, which saw unprecedented demand in its first three months on the market. As men rushed to pharmacies to get Viagra, the FDA received reports of misuse and deaths among people who had taken the drug.
Both the FDA and Pfizer have repeatedly said the drug is safe and effective when used as prescribed.
Separately, a study published in the upcoming issue of the Journal of the American College of Cardiology found that cholesterol-lowering drugs known as statins, which include Warner- Lambert Co.'s Lipitor and have multibillion dollar yearly sales, may not help all heart attack patients.
A previous study known as CARE found that patients who had suffered a heart attack and were given Bristol-Myers Squibb Co.'s statin Pravachol were 24 percent less likely to have another heart attack or die than patients given a placebo. When analyzing a subset of patients who already had low levels of the so-called bad LDL cholesterol, however, researchers found that Pravachol didn't make a significant difference.
The analysis was conducted by scientists from various universities and research centers around the U.S. and Canada. It was supported by a grant from Bristol-Myers. |