Efalizumab (marketed as Raptiva) Information

[4/8/2009] FDA has been informed by Genentech, Inc., the sponsor of Raptiva (efalizumab), of their decision to initiate a voluntary withdrawal of Raptiva. The voluntary withdrawal will occur in phases over the next several months. Genentech’s decision to withdraw is based on the finding of an association with the use of Raptiva and an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system. Over the next several months, healthcare providers will be transitioning patients with psoriasis currently using Raptiva to alternate treatments. Healthcare providers are being asked to not initiate Raptiva treatment for any new patients.

Contact FDA

1-800-FDA-0178 Fax
Report a Serious Problem

MedWatch Online

Regular Mail: Use postage-paid FDA Form 3500

Mail to: MedWatch 5600 Fishers Lane

Rockville, MD 20857

Page Last Updated: 07/10/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English