FDA News Digest

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At FDA's request, Purdue Pharma L.P. has agreed to withdraw its pain drugPalladone (hydromorphone) from the market after the agency determined thatpotentially fatal side effects could occur if patients take the drug withalcohol.

 

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01205.html<http://www.fda.gov/bbs/topics/NEWS/2005/NEW01205.html>

 

-- More information:http://www.fda.gov/cder/drug/infopage/palladone/default.htm<http://www.fda.gov/cder/drug/infopage/palladone/default.htm>

 

 

 

FDA Issues Advisory on Fentanyl Patches Following Death Reports

 

 

 

In response to reports of deaths among patients using fentanyl skin patches(Duragesic) for pain management, FDA has issued a public health advisoryurging patients using the product to follow directions exactly to prevent anoverdose of what it calls a "potent narcotic." The advisory is intended toinform patients and health care professionals who may not be fully aware ofthe drug's potential dangers.

 

-- FDA statement: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01206.html<http://www.fda.gov/bbs/topics/NEWS/2005/NEW01206.html>

 

-- More information:http://www.fda.gov/cder/drug/infopage/fentanyl/default.htm<http://www.fda.gov/cder/drug/infopage/fentanyl/default.htm>

 

 

 

First Generic Version of Retrovir Tentatively Approved for AIDS Relief

 

 

 

FDA has tentatively approved the first generic version of the HIV/AIDS drugRetrovir. The product will now be available for use outside the UnitedStates under the President's Emergency Plan for AIDS Relief.

 

http://www.fda.gov/bbs/topics/NEWS/2005/NEW01204.html<http://www.fda.gov/bbs/topics/NEWS/2005/NEW01204.html>

 

 

 

To view an archive of past FDA news releases, go to

 

http://www.fda.gov/opacom/hpnews.html<http://www.fda.gov/opacom/hpnews.html> .

 

 

To access the RSS feed of FDA news releases, go to

 

http://www.fda.gov/bbs/topics/news/rssPress.xml<http://www.fda.gov/bbs/topics/news/rssPress.xml> .

 

[What is an RSS feed? See<http://www.fda.gov/bbs/topics/news/newsfeeds.html>http://www.fda.gov/bbs/topics/news/newsfeeds.html.]

 

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