On Thurday, the US Food and Drug Administration (FDA) announced that it would enforce restrictions on the acne drug Accutane to prevent pregnant women from using the drug, which has been found to cause miscarriages and birth defects.
The restrictions, which fall under a program called iPledge, would come into force on March 1. Under the program, doctors, pharmacists and patients would have to register with the makers of the drug and the patients would have to sign consent forms and also undergo monthly pregnancy tests to rule out the use of the drug after conception. By Monday, 27,713 patients enrolled for the program, said Susan Cruzan, an FDA spokesperson.
Earlier, the date for the commencement of the iPledge program was November 1, 2005. However, the American Academy of Dermatology had requested the FDA to start the program at a later date so that the logistics could be put into place. This led to the delay till March this year. Among other concerns the doctors had shown were adequate staffing for the iPledge call center and providing passwords for registered users who had lost their passwords.
The FDA said that it had taken care of these concerns and the program was ready to roll. “FDA has ensured that rapid and significant progress has been made by the sponsors and Covance (the firm that would run the program) to address (the problems),” a statement released by the FDA said. “Specific measures undertaken have included an increase in iPledge call center staffing to handle the expected increases in call volume and user questions in the coming weeks, as well as an enhanced system to process requests for new passwords by users who have forgotten or lost their original passwords,” the statement added.
But some doctors are still skeptical that the time-consuming rules involving the drug might lead to patients trying to obtain the drug illegally over the Internet. Dr Diane M Thiboutot, of the Penn State University College of Medicine in Pennsylvania, felt that many needy patients would be affected by the program. “We're really concerned that this system may mark the beginning of an inability of patients who need the medication to get medication,” she said.
Accutane is also sold under the brand names of Amnesteem, Claravis and Sotret. Even though the drug, chemically called isotretinoin, is meant for severe cases of acne, many times it is prescribed for milder cases as well. The program also aims at preventing this kind of misuse of Accutane.
Ever since the drug was launched in 1982, the FDA has been trying to prevent women from using Accutane during pregnancy. However, in spite of the efforts, over 2,000 pregnancies were noted in the users, with most ending with miscarriages.
What's disturbing is that around 160 of the pregnancies resulted in the birth of babies that showed defects induced by the drug, leading the FDA to plan a stringent program to prevent such occurrences. Among defects seen in such babies are mental retardation, brain and heart complications. Over one million prescriptions for Accutane are handed out in the United States every year.
