EU Panel Approves Viagra; Final OK Pending

BRUSSELS —  Pfizer Inc. moved a step closer to the expected October introduction of its impotence pill, Viagra, in the 15-nation European Union by winning the support of a key medical committee.

Pfizer could get the final approval needed from the European Commission by Sept. 15 after the European Union’s committee on medicines recommended Monday the commission approve the drug.

With $411 million in sales in its first three months on the U.S. market, Viagra has had the most successful introduction ever. Analysts expect the European approval to boost sales because the European market has a population of about 370 million, compared with 270 million in the U.S.

The EU panel asked for a clear label warning of the drug’s “undesirable side effects.”

Clinical studies showed patients using Viagra reported impaired vision and headaches in greater frequency than people not using the drug.

The Food and Drug Administration also estimates that the drug was taken by 69 patients in the U.S. who later died. Many of those men, though, were taking heart drugs that are known to produce dangerous effects when they interact with Viagra. The danger is highlighted on Viagra’s label.

The FDA has said it hasn’t found Viagra to be the direct cause of death and both the agency and the company have repeatedly said the drug is safe when used properly.

The European Union is made up of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Ireland, Luxembourg, the Netherlands, Portugal, Spain, Sweden and Britain.

Shares of New York-based Pfizer rose $1.13 to close at $106.50 on the New York Stock Exchange. The stock has risen 91% in the last year, spurred by prospects for Viagra.