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

http://www.kaisernetwork.org/daily_reports/rep_women.cfm#43951

[Mar 30, 2007]
     FDA on Wednesday 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. The Web page is designed to
open when people conduct online searches for Accutane, as well as its
three generic 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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