FDA Mandates "iPLEDGE" Accutane Registry in Effort to Prevent Birth Defects

Patients Must Register by December 31, 2005 to Get Accutane Re-fills

In mid-August 2005 the FDA mandated that all patients who uses the acne drug Accutane will have to enroll in a national Accutane registry.  In addition, every doctor who prescribes Accutane and every drugstore that sells Accutane will have to participate. Essentially, this new Accutane registry is aimed at preventing women from becoming pregnant while using Accutane because it is a known birth defect-causing drug.

The FDA announced the long-anticipated Accutane registry program through its MedWatch program.  Significantly, this announcement came more than a year after the FDA's scientific advisers had urged the creation and implementation of an Accutane registry.  Those FDA advisers pointed out that more stringent restrictions were needed because repeated safety warnings in the past have failed to stop Accutane-damaged pregnancies.

Both male and female patients in the U.S. will have to enroll in the Accutane registry, called "iPLEDGE", by December 31, 2005 or they can no longer receive Accutane.

Pursuant to FDA action in the past, before their initial Accutane prescription, women of childbearing age are required to use two forms of birth control, get two negative pregnancy tests, and show proof of another negative pregnancy test before each monthly refill of Accutane. Now, the FDA hopes that by using the computerized Accutane registry system, doctors and pharmacists are able to ensure that women patients have taken all the necessary steps before getting an Accutane refill.

Birth defects are the primary concern with Accutane, and its generic version, isotretinoin. If a woman becomes pregnant while taking Accutane her baby can suffer severe brain and heart defects, mental retardation,and other abnormalities, even if the mother took only a small dose for a short period. That is a risk for 30 days after stopping the Accutane, too. 

The FDA has received reports of more than 2,000 pregnancies among Accutane users since the Accutane came on the market in 1982. The vast majority of those Accutane-damaged pregnancies ended in abortion.  At least 160 babies, however, have been born with Accutane-caused defects.  Significantly, there are probably many more Accutane pregnancies because, to date, doctors have not been required to report pregnancies in women using Accutane. The new rules associated with the Accutane registry require doctors to report Accutane pregnancies to the FDA, now.

The Accutane registry opened on August 22, 2005 in order to give adequate time for doctors, patients, and pharmacies to understand how the registry will work before the provisions become mandatory on December 31, 2005.

Lastly, all Accutane patients must sign a document informing them of Accutane's risks, including the possibility that Accutane contributes to depression or suicidal thoughts -- a warning that the FDA also strengthened in July 2005.

Read the complete MedWatch 2005 Accutane Safety Summary, including a link to the FDA Public Health Advisory and Press Release, FDA Drug Information Page, Healthcare Professional Information Sheet, FDA Patient Information Sheet, and the approved product labeling.

(Posted by: Tom Lamb)