美國食品藥物管理局(FDA)發布有關止痛藥propoxyphene的過量風險警告,這是一般銷售,並且以Darvon和Darvocet品牌名稱銷售。

DarvonN100.jpg darvocet-n_11520_6_(big)_.jpg
  


  美國FDA的黑盒子警告(黑框警告)─FDA的嚴厲警告,強調有關含有propoxyphene的藥物有潛在的過量風險;FDA也要求未來要進行更多與propoxyphene安全性有關的研究。
  
  雖然諮詢委員會在一月份建議這項禁令,但是FDA並未禁止propoxyphene。FDA經常遵循其諮詢委員會的建議,但當局並不一定需要這麼做。 
  
  在這種情況下,FDA藥物評估與研究中心主任Janet Woodcock博士在記者會中表示,FDA確定含有propoxyphene的藥物,在接受指導的情況下,對於輕度至中度疼痛是一種可接受的選擇。
  
  Propoxyphene自1957年來即在市場上販售;1969至2005年間,FDA共接獲91位服用propoxyphene死亡的案例報告;FDA流行監測及流行病學辦公室主任Gerald Dal Pan博士在記者會中表示,大多數的死亡是用藥劑量過量,以及自殺未遂事件,通常涉及多種藥物。
  
  Woodcock表示,非營利組織Public Citizen於2006年遞交了一份請願書,要求禁止這種藥物,FDA因而再度探討propoxyphene。
  
  Woodcock也指出,FDA一直在審查其他類型的止痛藥,包括上週有關乙醯胺酚(acetaminophen)安全性的會議。

FDA Strengthens 'Black Box' Warning and Orders More Studies for Painkiller Propoxyphene, Sold Generically and as Darvon and Darvocet

July 7, 2009 -- The FDA today ordered new warnings about overdose risk for the pain medicationpropoxyphene, which is sold generically and under the brand names Darvon and Darvocet.

 

The FDA is requiring the "black box" warning -- the FDA's sternest warning -- on drugs containing propoxyphene to emphasize the potential for overdose. The FDA also ordered more studies of propoxyphene's safety.

But the FDA didn't ban propoxyphene, although an advisory committee narrowly voted in January to recommend such a ban.?/p>

The FDA often follows the advice of its advisory committees, but it's not required to do so.

In this case, the FDA decided that drugs containing propoxyphene are an "acceptable option for mild to moderate pain when taken as directed," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said today in a news conference.

Propoxyphene has been on the market since 1957. From 1969 to 2005, the FDA got 91 reports of deaths in people taking propoxyphene. Most of those deaths were drug overdoses and suicideattempts, often involving multiple drugs, Gerald Dal Pan, MD, MPH, director of the FDA's Office of Surveillance and Epidemiology, said during today's news conference.

Woodcock said the FDA took another look at propoxyphene after the nonprofit group Public Citizen filed a petition in 2006 calling for the drug's ban. Woodcock also noted that the FDA has been reviewing other types of pain relievers, including last week's meeting on acetaminophen safety.

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