Claris Law Legal Blogging Community

Name:

E-mail:

Phone Number:

Zip Code:

Your Question:

Editor: Renee Preston
Profession: Attorney at Law

Category: The FDA and Accutane

The FDA now requires doctors who prescribe Accutane and women of childbearing age who take Accutane to register with the new iPLEDGE program, acknowledging that they are aware of the risks involved.

The FDA approved iPLEDGE as a risk management program for Accutane, a drug used to treat severe nodular acne and linked with serious side effects including birth defects, depression and suicide. Generic names for Accutane, manufactured by Roche Pharmaceuticals, include Amnesteem, Claravis, Istretinoin and Sotret.

In an apparent effort to prevent females who are taking Accutane from becoming pregnant, the FDA has asked Roche Pharmaceuticals to implement the iPLEDGE program. The program may also help raise awareness of the risks involved with taking this medication.

According to the FDA, since March 1, 2006, only prescribers registered and activated in iPLEDGE are able to prescribe Accutane, and only patients registered and qualified in iPLEDGE are able to be dispensed Accutane.