To: zurdo who wrote (2745 ) 5/22/1998 1:25:00 PM From: Anthony Wong Respond to of 9523
[news include analyst comments]Pfizer's Viagra Associated With 6 Deaths, FDA Says (Update2) Bloomberg News May 22, 1998, 10:15 a.m. PT Pfizer's Viagra Associated With 6 Deaths, FDA Says (Update2) (Updates shares, adds background, comment from analysts and company in second section.) Washington, May 22 (Bloomberg) -- Pfizer Inc. reported that six patients taking the new impotence drug Viagra died, the U.S. Food and Drug Administration said, sending Pfizer shares down as much as 5 1/8 to 104. ''The company reported to FDA yesterday it has learned of six deaths of patients who took Viagra,'' said agency spokeswoman Ivy Kupec. It's still unknown if Viagra played any role in the deaths. Companies are required to report any health problems encountered by patients taking a drug, so the FDA can ensure the safety of a medication. The FDA is investigating the reports, which came late yesterday, and the drug will remain on the market, Kupec said. ''FDA continues to believe the drug is safe and effective for its labeled indication and intended patient population,'' she Kupec. She said the agency has asked Pfizer to provide more information to patients on the proper use of the drug. Kupec said she could not comment on the circumstances of the reported deaths. 8 Deaths During Trials ''As far as I know, nothing has been definitely linked to Viagra,'' said Hambrecht & Quist analyst Alex Zisson, who has a ''buy'' rating on Pfizer. ''It's just that the FDA collects any adverse events on any patient on any drug,'' he said. Pfizer confirmed that there were eight deaths among men who took Viagra as part of the tests Pfizer conducted to win FDA aproval. FDA reviewers didn't find proof Viagra was to blame, said Andrew McCormick, a Pfizer spokesman. Pfizer has 1,500 salespeople to pitch Viagra to doctors, McCormick said. They are supposed to tell doctors to check cardiovascular history, he said. Doctors also should review with patients the possible risks of resuming intercourse after a long interval ''between episodes,'' he said. The New York-based drugmaker said there have been more than 1 million prescriptions for Viagra since it was introduced last month. Yesterday, Pfizer said it sent warnings to doctors and patients to reiterate guidelines for using the drug. It can be dangerous when combined with nitroglycerin, the company said. ''I'm betting (the reported deaths are) not due to a new side effect of the drug, but to misuse of it,'' said James Keeney, an analyst with ABN Amro, who has a ''buy'' rating on Pfizer. Some men may have overexerted themselves while taking the drug or improperly combined with it other drugs, he said. ''Once you get usage in a million people instead of 5,000, rare side effects can emerge,'' Zisson said. Viagra's label already contains a warning that it shouldn't be used by those taking organic nitrates such as nitroglycerin, primarily used to treat angina, chest pain due to clogged arteries. In a statement yesterday, the drugmaker cautioned that using them together could cause a sudden drop in blood pressure. Viagra, which is easier to use than other impotence remedies on the market, became one of the best-selling U.S. drugs after its introduction last month. When it won FDA approval in late March, analysts said its annual sales could reach as much as $4 billion. Pfizer said it will send out 10,000 letters this week to reach emergency room personnel who might not realize they're treating Viagra users. Vivus Inc. currently has an impotence treatment on the market that works by delivering a drug through the urethra. Zonagen Inc. and TAP Holdings Inc., a joint venture of Abbott Laboratories and Takeda Chemical Industries Ltd. are also developing oral medications to treat impotence. --Kristin Jensen in Washington, Michelle Fay Cortez in Ithaca, More News: PFE