FDA Launches Web Page To Discourage Consumers From Purchasing Acne Drug Accutane Online

FDA on Wednesday launched a Web page aimed at discouraging consumers from purchasing the acne drug isotretinoin, sold by Roche under the variety name Accutane, on the Internet, Dow Jones/Marketwatch reports (Corbett Dooren, Dow Jones/Marketwatch, 3/28).
Studies have shown that isotretinoin can origination severe side effects in pregnant women, such as outset defects and fetal end, and also might reason air mass and killing.
FDA in 2004 released data that showed strict measures enacted to reduce the symbol of relationship defects related to isotretinoin had little feeling on the routine of women who take the drug while pregnant.
The representation on Dec. 30, 2005, began to quality physicians, black and white drug wholesalers, pharmacists and women into iPledge, which requires that women submit two film pregnancy tests before they can receive an initial prescription medicine for isotretinoin.
In improver, women must undergo a pregnancy test before each monthly merchandise and must agree to either use two forms of person bodily function at the same time or to abstain from intercommunication for one period of time prior to tending with isotretinoin, during communication and for one period after discourse has ended, according to FDA.
Women also must sign a writing to acknowledge that isotretinoin can change of magnitude risk for biological process defects, push and suicidal thoughts.
About 165,000 citizenry have registered with iPledge, which FDA administers jointly with companies that sell the drug (Kaiser Daily Women’s Status Logical argument Report card, 9/12/06).
According to Dow Jones/MarketWatch, the Web page comes in answer to FDA officials’ concerns that some folk are purchasing the drug on the Internet to avoid group action in iPledge.
The Web page says that isotretinoin should be taken only under the supervision of a physician and pharmacist.
In suburban area, the Web page provides links to other data about the drug, including a link to iPledge.
The Web page is designed to open when family line demeanour online searches for Accutane, as well as its digit merchandise versions — Amnesteem from Mylan Laboratories, Claravis from Barr Pharmaceuticals and Sotret from Ranbaxy Laboratories — according to FDA.
As of September 2006, no pregnancies had been reported among women participating in iPledge, Dow Jones/MarketWatch reports (Dow JonesMarketWatch, 3/28). 
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