FDA, FIRMS IMPLEMENT ACCUTANE SAFETY PROGRAM

The FDA and manufacturers of the acne drug Accutane and its generic equivalents have launched the iPLEDGE program to help prevent pregnant women from using the drug, which has been linked to birth defects.

To obtain Accutane (isotretinoin), women must register with iPLEDGE and comply with a number of other requirements. Women of childbearing age must be tested for pregnancy; and all registrants must complete an informed consent form, and obtain counseling about the risks and requirements for safe use of the drug, which is used to treat severe acne.

In addition to its potential link to birth defects, recent findings show that isotretinoin may be associated with severe depression.

Many doctors, wholesalers and pharmacies have registered in the iPLEDGE program, the FDA said. In addition, during the past few weeks, more than 1,200 patients per day have registered with iPLEDGE.

FDA said it has also increased iPLEDGE call center staffing to handle the expected increases in call volume and user questions in the coming weeks.