The strict regulations governing the prescription and use of the acne drug isotretinoin, sold by Roche under the brand name Accutane, are affecting the drug's sale and dispensation and raising concerns about sales of the medication over the Internet, the Wall Street Journal reports (Corbett Dooren, Wall Street Journal, 9/12).
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 that 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 monthly 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 is administered together with companies that sell the drug.
However, critics say that iPledge is poorly administered (Kaiser Daily Women's Health Policy Report, 9/5).
Isotretinion is one of about two dozen drugs prescribed under a "restricted-access plan intended to curb misuse or unnecessary side effects," the Journal reports.
According to the IMS Health, a company that tracks prescription drug sales, the number of Accutane prescriptions in the first half of 2006 decreased by 46% compared with the same period in 2005, and prescriptions for the leading generic version fell by 16% in the same time period.
iPledge "may turn into something of a referendum" on FDA's "ability to manage the risks and benefits of powerful drugs," the Journal reports.
To discourage people from purchasing isotretinoin online, FDA in the next six months is expected to discuss with drug manufacturers ways to change iPledge, including making required monthly physician visits more flexible and easing the requirement that patients obtain the medication within seven days after it is prescribed.
In addition, FDA is creating a Web site that aims to "pop up" when isotretinoin is typed into a search engine to discourage people from purchasing the drug over the Internet (Wall Street Journal, 9/12).
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