독일 보건부 발표에 의하면  세계적으로 발기부전 치료제 ‘비아그라’를 복용한 환자들 중에  무려 616명이 부작용으로 사망한 것으로 밝혀졌다. 이들 대부분이  비아그라를 잘못 사용해 발생하였다며 처방 가이드라인 및 유통체계를 재검토할 방침이라고 하였다. 우리나라에서도 식품의약품안전청 자료에 따르면  비아그라에 의한 부작용 사례 접수건수가 전체의 48%에 이르는 것으로 집계됐다.


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Germany Says 616 Die Worldwide After Viagra Use
(Reuters/Friday, September 7, 2001)

Germany's health ministry said Friday that 616 people worldwide had died after using Pfizer Inc.'s Viagra but cautioned against attributing blame for the deaths to the anti-impotence drug.

In a response to a request by a Member of Parliament, the ministry said the data bank of the Swedish-based Uppsala Monitoring Center (UMC) had recorded 616 cases of people who had died after using Viagra.

A spokesman for New York-based Pfizer, the world's largest pharmaceutical firm, told Reuters the drug is safe and effective when used as prescribed.

"Well-controlled clinical trials show no difference in the incidence of heart attack or death between patients treated with Viagra and those treated with (an inactive) placebo," said Jeoff Cook, spokesman for Pfizer.

The German Institute for Pharmaceutical and Medical Products has recorded 77 deaths in the European Union and 30 in Germany, the ministry said.

A spokeswoman for the health ministry said she could only comment about the German cases, in which she said existing health problems rather than Viagra appeared to be the main cause of death.

"In the 30 German cases, the patient died at some time after taking Viagra, usually as a result of a heart or circulation complication," she said. "You cannot say that these people died because they took Viagra. These were cases where the people appeared to have had heart or circulation problems and the medicine was therefore probably not suitable for them."

There have been several reports of heart attacks among men taking Viagra, although a study of 5,600 users in England earlier this year said the drug does not increase the risk of heart attacks and heart disease in men.

"Many patients taking Viagra have underlying cardiovascular disease, such as hypertension. Erectile dysfunction is a symptom of those conditions, so they already have risk factors for heart attack," Cook said.

Viagra, launched in the United States in 1998, reaped more than $1 billion in sales for New York-based Pfizer last year. Cook said 15 million men have taken Viagra since its introduction.