Pfizer Probes Deaths Amid Gripes on Viagra Guidance

Last week, Pfizer and the Food and Drug Administration confirmed that the company had reported six deaths of Viagra users to the FDA under rules that require the company to report serious or unexpected adverse effects to the agency. Both Pfizer and the FDA said they aren't certain what, if any,...

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Bibliographic Details
Published inThe Wall Street journal. Eastern edition
Main Author By Nancy Ann Jeffrey And Andrea Petersen
Format Newspaper Article
LanguageEnglish
Published New York, N.Y Dow Jones & Company Inc 27.05.1998
EditionEastern edition
Subjects
Cardiovascular disease
Diabetes
Fatalities
FDA approval
Heart
Investigations
Nitrates
Paramedics
Patients
Physicians
Prescription drugs
Salespeople
Sexual disorders
Side effects
Urology
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Summary:Last week, Pfizer and the Food and Drug Administration confirmed that the company had reported six deaths of Viagra users to the FDA under rules that require the company to report serious or unexpected adverse effects to the agency. Both Pfizer and the FDA said they aren't certain what, if any, role Viagra played in the deaths. Moreover, Pfizer and the FDA maintained that the drug is considered very safe. At this time there is no evidence that any further restrictions are needed beyond those that already are in the drug's label, the FDA and Pfizer said. In an interview yesterday, Joseph Feczko, senior vice president for medical and regulatory operations for Pfizer, said the company has taken steps to stress to physicians and the public that the drug's label warns against combining Viagra with commonly used heart-disease medicines containing nitrate-type chemicals such as nitroglycerin. Last week, the company mailed out 21,000 letters to the country's emergency-room doctors alerting them that men complaining of chest pains, perhaps due to heart disease, should be asked if they are taking Viagra before being given nitrate-type drugs that often are prescribed to treat angina, severe chest pains often accompanying heart disease. Dr. Feczko also said Pfizer has been calling officials at medical associations representing emergency-care workers across the country to get the word out about the interaction warning. But Pfizer reiterated that its action, while occurring in the wake of reports of the six deaths, is not a direct result of those disclosures. Instead, the company said it felt the additional alert was prudent given the drug's exceptionally high use and inquiries Pfizer sales representatives received from doctors. Since the first marketing of the drug in early April, more than one million men have filled Viagra prescriptions, making the drug one of the fastest-growing new drugs ever. Pfizer shares, which moved up sharply in recent weeks, fell 3.4% Friday on news of the deaths. In composite New York Stock Exchange trading, Pfizer shares yesterday fell 2.1%, down $2.25 to $103.1875, in volume slightly above average.
ISSN:0099-9660