On Wednesday, the FDA launched a special Web pageaimed at discouraging consumers from purchasing the acne drug isotretinoin, sold by Roche under the brand name Accutane, on the Internet. The drug claims to cure severe acne that is not controlled by other treatment forms.
The FDA warning page appears in online search results for Accutane (isotretinoin) or its other generic versions (Amnesteem, Claravis, or Sotret). FDA advises that this drug be taken only under the direction of a physician or a pharmacist. It warns that if used improperly, the drug causes birth defects and severe mental health problems.
Research studies have revealed that isotretinoin causes severe side effects in expectant mothers, such as birth defects and fetal death, and also might cause depression and suicide.
Isotretinoin manufacturers have already issued safeguards to reduce the risks of the drug, like the iPLEDGE risk management program. They warn women using isotretinoin to stop using the drug in case of pregnancy and pregnant women not to use isotretinoin.
FDA data released in 2004 showed that these measures had little effect on the number of pregnant women taking the drug.
Then the FDA began to register physicians, prescription drug wholesalers, pharmacists and women into iPledge, since Dec. 30, 2005, which asks women to submit two negative pregnancy tests in order to receive a prescription for isotretinoin. About 165,000 people have registered with iPledge, which FDA administers jointly with companies that sell the drug.
Women have to undergo a pregnancy test every month and must accept to use two different forms of birth control at the time of treatment with isotretinoin and for one month after treatment has ended, according to FDA. They also have to sign a text to acknowledge that isotretinoin can amplify risk for birth defects, depression and suicidal thoughts.
The Web page was launched as FDA officials' felt that some are purchasing the drug on line to avoid involvement in iPledge.
The Web page has links to other info about the drug, including a link to iPledge. The Web page gets connected when people search for Accutane, or any of its three generic versions -- Amnesteem from Mylan Laboratories, Claravis from Barr Pharmaceuticals and Sotret from Ranbaxy Laboratories.