November 20, 2008
Pfizer Ends Viagra’s Over-The-Counter Bid
Pfizer has decided to withdraw its application for the anti-impotence drug Viagra to be available without a prescription.
The company came to the decision after European regulators raised concerns about supply.
A European Medicines Agency committee said there would be too little medical oversight concerning possible related problems like heart disease.
Since its launch a decade ago, around 35 million men around the world have taken Viagra.
Pfizer applied to have Viagra's 50mg tablets available over-the-counter, claiming the move would help those men too embarrassed to seek help from their doctor.
"A lot of men don't go to the doctor or talk about their condition," said a company spokesman. "By offering it via a pharmacy, it would offer them another option."
The company argued it could also help prevent men buying over the Internet and potentially taking fake, and even dangerous, pills.
However, the EMEA's Committee for Medicinal Products for Human Use (CHMP), cited major concerns over making Viagra available over-the-counter.
"If the drug is available without prescription, there is no medical supervision which could delay diagnosis of underlying disease," said a spokeswoman.
"The CHMP was particularly worried about the diagnosis of overt and silent cardiovascular disease, of which ED can be an early marker."
Concerns were also raised over complicated product information, which could lead men to "unintentional misuse".
"In addition, a switch to being an over-the-counter medicine could lead to an increase in people who are not intended users taking Viagra recreationally."
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