FDA last week launched a Web page aimed at discouraging consumers from purchasing the acne drug isotretinoin, sold by Roche under the brand name Accutane, on the Internet, Dow Jones/Marketwatch reports (Corbett Dooren, Dow Jones/Marketwatch, 3/28).
Studies have shown that isotretinoin can cause severe side effects in pregnant women, such as birth defects and fetal death, and also might cause depression and suicide.
FDA in 2004 released data that showed strict measures enacted to reduce the number of birth defects related to isotretinoin had little effect on the number of women who take the drug while pregnant.
The agency on Dec. 30, 2005, began to register physicians, prescription drug wholesalers, pharmacists and women into iPledge, which requires that women submit two negative pregnancy tests before they can receive an initial prescription for isotretinoin.
In addition, women must undergo a pregnancy test before each monthly refill and must agree to either use two forms of birth control at the same time or to abstain from intercourse for one month prior to treatment with isotretinoin, during treatment and for one month after treatment has ended, according to FDA.
Women also must sign a document to acknowledge that isotretinoin can increase risk for birth defects, depression and suicidal thoughts.
About 165,000 people have registered with iPledge, which FDA administers jointly with companies that sell the drug (Kaiser Daily Women's Health Policy Report, 9/12/06).
According to Dow Jones/MarketWatch, the Web page comes in response to FDA officials' concerns that some people are purchasing the drug on the Internet to avoid participation in iPledge.
The Web page says that isotretinoin should be taken only under the supervision of a physician and pharmacist.
In addition, the Web page provides links to other information about the drug, including a link to iPledge.