◆약사/의약품유통/▷외신(의약품, 외국제약업계)

'아반디아' 美 소비자단체 販禁 촉구로 곤혹

jean pierre 2008. 11. 1. 08:06
반응형

                 '아반디아' 美 소비자단체 販禁  촉구로 곤혹
                
         퍼블릭시티즌, FDA 에 여러부작용 근거 청원서 제출
             GSK측 성명, "복약안내 지도 잘 따르면 안전"  

성인당뇨 치료제인 '아반디아'가 미국 소비자단체의 판매금지 촉구로 곤혹을 치르고 있다.

최근 미국 소비자단체인 퍼블릭 시티즌(Public Citizen)은 2형(성인)당뇨병 치료제 아반디아(화학명: 로지글리타존)가 심장과 간 손상을 포함해 여러가지 심각한 부작용에 노출돼 있다고 밝혔다. 이에따라 이들은 미 식품의약국에 이를 판매중지해줄 것을 촉구했다.

 이들은 탄원서에서 "아반디아가 심장마비, 심부전, 간부전 등 생명을 위협할 수 있는 부작용이 있음이 분명하며 아반디아를 복용한 환자 14명이 간부전이 나타났으며 이중 12명이 사망했고 일부 환자는 눈에 문제가 생기고 빈혈과 골절증상도 나타났다"고 자체조사 결과를 근거로 제시했다.

            그러나 미 식품의약국 대변인 Karen Riley는 "이 약물의 안전에 대해 여러가지 데이타를 추적하고 있는 중이며 청원서를 신중하게 검토하겠다"는 반응을 보이고 있다.

한편 아반디아는 2년전부터 복용환자에 대한 심장마비 위험이 43%가 높다는 임상결과이후 안전성에 문제가 제기돼왔다. 이와관련 이 제품의 매출액 또한 크게 줄어들기 시작했다.


이와관련  글락소스미스클라인측은 성명을 통해 " 내부자료는 안전성이 있음을 보여주고 있고 심장마비 관련 자료도 아직은 확실하게 결론난 것이 아니다"고 밝히고 "복약지도서에 의해 안전하게 복용한다면 효과나 안전성 측면에서 도움이 된다"고 강조했다.

이와 비슷한 약물인 화이자의 레줄린이 간에 대한 부작용으로 인해 2000년 판매금지된 적이있다.

메디코파마뉴스/데일리엠디 김종필 기자(www.nate.com)

◆원문기사

WASHINGTON, Oct 30 (Reuters) - More than one dozen cases of liver failure and death were reported in patients taking GlaxoSmithKline Plc's (GSK.L: Quote, Profile, Research, Stock Buzz) (GSK.N: Quote, Profile, Research, Stock Buzz) Avandia, advocacy group Public Citizen said on Thursday in a petition calling for a ban of the diabetes drug.

But GlaxoSmithKline defended its drug, saying its own review by an independent panel earlier this year said the liver risks were acceptable.

"We do not believe there is a connection between liver toxicity and this medicine," the company said in a statement, adding it had not yet read the group's petition.

Public Citizen said its review of U.S. Food and Drug Administration data found 14 previously unpublished cases of severe drug-induced liver failure, including 12 deaths.

That risk, coupled with other known complications that include heart failure, fractures and vision loss, was too great to allow the drug to continue to be sold in the United States, especially with other treatments available, it said in a petition to the FDA.

"The evidence for this unique combination of toxicities is compounded by the accompanying lack of evidence of any clinical benefit, compared to other approved drugs for diabetes," the petition said.

FDA spokeswoman Karen Riley said the agency would review the petition.

Sales of Avandia -- also known as rosiglitazone and part of a new class of drugs to treat type 2 diabetes called glitazones -- have plunged in the past year after the heart risk surfaced in an analysis of available clinical studies.

Additionally, experts at two major diabetes associations have withdrawn their support of the drug, instead backing lifestyle changes such as diet and exercise as well as other treatments.

Third-quarter sales of the drug fell 23 percent to 191 million pounds ($314 million) compared to 2007, the company said last week.

Still, Public Citizen estimated about 10,000 prescriptions continue to be filled each day. "Thus, it is urgent for the FDA to immediately ban rosiglitazone," it said.

Another similar diabetes drug, troglitazone, was pulled from the U.S. market in 2000 because of liver toxicity. The drug, called Rezulin, was sold by Parke-Davis/Warner-Lambert, which later became part of Pfizer Inc (PFE.N: Quote, Profile, Research, Stock Buzz).

The British drugmaker's shares trimmed earlier gains and were up 22 cents, or 0.6 percent, at $37.54 in late afternoon trading on the New York Stock Exchange. In London, its shares closed down 1.6 percent. (Editing by Maureen Bavdek and Bernard Orr)

 

반응형