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Subscribe To Our Syndicated NewsAccutane national registry hopes to reduce risks of birth defects
- August 13, 2005
As part of a major government program to tighten access to the acne drug Accutane because of the risks of birth defects that can occur with its use, patients taking the medicine will have to enroll in a national registry called iPLEDGE. Accutane has been on the market since 1992, and the FDA has since received reports of over 2,000 pregnancies among users.
Most of the reported Accutane pregnancies ended in abortion or miscarriage, but the agency counts more than 160 babies born with drug caused defects. Because of vast underreporting, critics that have been pushing for stricter Accutane guidelines for years say the number of birth defects resulting from Accutane is probably significantly greater.
The FDA first attempted to tighten Accutane access in 2001, but the restrictions were voluntary and didn't prove effective. In the first year of the program, the FDA counted 120 pregnancies among the drug's users, just seven fewer than in the previous year despite the 23 percent drop in overall prescriptions.
After two decades of failed safety warnings and restrictions, critics believe this is the FDA's last chance to implement a program that will ensure women using the controversial medicine avoid pregnancy. If a woman becomes pregnant while taking Accutane, her baby can suffer severe birth defects, including severe brain and heart defects, mental retardation and other abnormalities. Even a small dose of Accutane for a short period of time can present serious birth defect risks, which remain for 30 days after discontinuing the drug's use.
IPLEDGE is a computerized registry that every patient - men and women- must enroll in starting Dec. 31 to receive Accutane or generic versions of the drug. Doctors who wish to continue prescribing Accutane must also register, and drugstores and wholesalers must register to have the pills' manufacturers ship them any supplies.
Under the program, all patients must sign a document informing them of Accutane's risks, including the possibility that it contributes to depression or suicidal thoughts. The FDA also strengthened Accutane's label to reflect the possibility of suffering depression or suicidal thoughts after charges that the drug was responsible for suicide deaths among otherwise mentally healthy teens were reported.
The patients must agree to monthly doctor visits for refills, as well as not to share the pills with anyone. The doctor will then register each patient into the iPLEDGE database, giving him or her a special identifying code number, and then write the prescription. For women of childbearing age wishing to go on Accutane, the program requires additional steps.
The female patient must undergo two tests to ensure they are not pregnant in a laboratory or doctor's office before the initial prescription, and monthly pregnancy testing before each refill, not counting home pregnancies. Doctors must enter the pregnancy test result to the iPLEDGE system, and the woman must buy the Accutane pills within seven days. The patients must also agree to use two forms of birth control while using Accutane, and must self-register on iPLEDGE, in addition to the doctor's initial registration, to report they are adhering to the guidelines.
The registry will open on Aug. 22 to give users extra time to familiarize themselves with the site before the provisions become mandatory at the close of the year.For more information on Accutane, please contact us.
