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Deaths spur Viagra probe
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May 22, 1998: 5:33 p.m. ET
FDA investigates after deaths of six men who took Pfizer anti-impotence pill
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NEW YORK (CNNfn) - The deaths of six men who were taking Viagra, the blockbuster sexual potency pill, has prompted federal regulators to take a closer look at the product -- now in its seventh week on the U.S. market.
The Food and Drug Administration confirmed Friday it is investigating the deaths of the men who died after taking the impotence drug, developed by the New York pharmaceutical giant Pfizer Inc.
So far, FDA spokeswoman Lori McHugh said the product has not been identified as the cause of those deaths. And analysts say it is still too soon to say what sort of long-term effect the news could have on Pfizer's stock price and sales.
"We thought the stock price was too high even before this development, so we wouldn't be surprised if it had a short-term impact on stock price," said Argus Research analyst John M. Eade. "It depends on how quickly the company reacts -- if it issues letters to physicians instructing them to be aware of the potential side effects."
Pfizer is already on it.
The company Thursday issued a statement saying it has maintained all along that users should adhere to proper safety guidelines when taking the drug.
"In view of the widespread commentary surrounding Viagra, we believe it is prudent and responsible to restate the appropriate use of this breakthrough medicine as well as to caution against inappropriate use," said Joseph Feczko, the company's senior vice president of medical and regulatory operations.
Pfizer (PFE) shares fell 4-3/16 Friday on the New York Stocks Exchange to close at 105-15/16. The company's stock price has climbed steadily to a high of 121-3/4 earlier this month, up from about less than 50 this time last year.
Among its list of safety tips, Pfizer reiterated Thursday that patients taking nitrates in any form, including nitroglycerin and long-acting nitrates commonly used for chest pain, should avoid the product.
The company also noted that sexual activity carries with it a certain degree of cardiovascular risk, particularly among older patients with known heart problems.
The FDA, which approved Viagra on a fast-track status, said eight patients died during the Viagra clinical trials but none of those deaths were related to the drug.
"It is important that people read the label and talk to their physicians to tell them what other medications they are on," McHugh said.
The investigation of the recent deaths is standard procedure, she added.
Because of the soaring demand for the drug, many insurers, including Oxford Health Plans Inc., still are formulating long-term coverage policies regarding Viagra. The product sells for about $10 a pill.
Patients obtained 570,000 new prescriptions for Viagra in April. That is the greatest number ever for a drug in its first month on the U.S. market, according to the Scott-Levin prescription drug audit service.
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