Viagra 's Sales
Slow From Pace
Of 1998 Launch
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Reports of Adverse Events
Take a Toll, and Some
Aren't Helped by Drug
By Otesa Middleton
03/29/99
The Wall Street Journal
WASHINGTON -- A year ago, Pfizer Inc.'s eagerly anticipated impotence pill, Viagra , won regulatory approval and hit the market with a bang, becoming the most successful drug launch ever.
Physicians last April wrote 598,000 prescriptions for the drug, according to pharmaceutical-sales auditor IMS Health, and prescriptions doubled the following month to 1.26 million.
The little blue pill not only racked up sales, but it got people talking about the sensitive subject of erectile dysfunction.
Viagra 's record-breaking sales growth didn't last, as some men found they fell into the category of the 30% the drug didn't help. Some insurers denied coverage of the $10 pill, deterring other users. Prescriptions dropped below 1.1 million last June, then to 891,000 in July. Since then, IMS's data show monthly prescriptions have remained around 700,000.
The biggest deterrent might have been deaths linked to the drug. Although the U.S. Food and Drug Administration continues to stand behind the safety and effectiveness of Viagra , the agency strengthened warnings on the drug's label in November, after 130 men taking the drug had died. The FDA said Viagra wasn't determined to have caused the deaths, but men with heart trouble and other ailments should be careful about using the pill.
From November to February, about 90 additional deaths were reported among American men taking the drug, according to the Adverse Event Report, which Dow Jones Newswires obtained under the Freedom of Information Act. The report lists cases that name Viagra as a "suspect" drug without establishing any definite relationship to a patient's death. In three cases, for example, patients committed suicide, but the deaths were reported to the FDA because the men used Viagra .
The reports came from various sources, including patients, physicians and pharmacists, and some cases may be duplicates, according to FDA spokeswoman Susan Cruzan.
The FDA report also lists side effects that may or may not have resulted from using Viagra . Many of the reactions, such as changes in blood pressure, stroke and cardiovascular events, are common among older men, the drug's main demographic group of users.
Other reactions to Viagra mentioned in the FDA report include: abnormal hair growth, speech disorder, amnesia, loss of libido, hallucination, anorexia, tinnitus, skin discoloration, hiccups, sleepwalking, eye rolling, hostility, euphoric mood, dry mouth, agitation, confusion, insomnia, abnormal thinking, abnormal skin odor, depression, increased sweating, flatulence, abnormal dreams and belching.
As with all drugs, Ms. Cruzan said, the FDA continues to monitor reports about Viagra . "We updated the labeling in November, and since then all issues are the same," she said. "We never established a direct link to Viagra with the reports. We updated the labeling so doctors had all of the information to make informed decisions about using the drug."
Pfizer spokeswoman Mariann Caprino said the company doesn't make public its tally or assessment of adverse-events data, but forwards such information to the FDA.
According to pharmaceutical analyst Le Anne Zhao of Southeast Research Partners, a variety of factors contributed to Viagra 's sales' trailing off. "The launch was terrific," she said. "No one expected that. The initial three months of sales was pent-up demand." In addition, the widespread media attention and former presidential candidate Bob Dole's telling the world he participated in the trials made Americans eager to try what they thought was a miracle drug, Ms. Zhao said. Prescriptions decreased "after the initial demand was fulfilled and people started seeing side effects," she added. She expects most of Viagra 's future growth to come from international markets.
Viagra 's success goes beyond the drug itself, Ms. Zhao said. " Viagra definitely opened the market," she said. "Before people were shy and embarrassed to talk about the subject." The number of men who went to see a doctor about penile disorders rose 75% last year to 4.8 million from 2.8 million in 1997, according to IMS.
Deutsche Bank Securities Inc. analyst Mariola Haggar said Viagra is still a very successful product. "Before the deaths and the precautions, there was a great curiosity factor," she said. "People were prescribing it indiscriminately and giving it to old patients who had histories of heart attacks, who hadn't had sexual activity in several years."
Ms. Haggar originally projected that in Viagra 's second year on the market, sales would hit $2 billion world-wide. Now she puts that figure closer to $1.5 billion, with $700 million coming from the U.S. "New prescriptions never got back to the original trajectory," she said. "These are still aggressive numbers."
She sees potential for growth, however. "Pfizer only recently embarked on moreaggressive, direct-to-consumer advertising, which has the potential to improve sales," she said. "There has been fairly good resale growth among people who have tried the drug. New-prescription growth has been somewhat erratic."
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