The heartbreak of psoriasis has one more heartbreak, as with many other drugs in the news of late, potential side effects are the news here. BD
South San Francisco, Calif. -- April 8, 2009 -- Genentech, Inc. announced today a phased voluntary withdrawal of the psoriasis drug
Raptiva® (efalizumab) from the U.S. market. The company's decision is based on the association of Raptiva with an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system. Raptiva is indicated for the treatment of chronic moderate-to-severe plaque psoriasis in adults 18 years or older who are candidates for systemic therapy or phototherapy.
Effective immediately, physicians should not issue prescriptions for Raptiva for any new patients and should promptly contact patients currently receiving Raptiva to assess the most appropriate treatment alternatives. Raptiva will no longer be available after June 8, 2009. This transition period is intended to allow patients, who are currently taking Raptiva, enough time to work with their doctors to appropriately discontinue use of Raptiva. Because of the potential for severe psoriasis worsening with abrupt discontinuation of Raptiva, it is important that patients talk with their doctor before stopping treatment.
Physicians with questions about Raptiva use may contact Genentech Medical Communications at 1-800-821-8590.
Genentech: Newsroom: Press Releases: News Release April 8, 2009
A product recall is a great loss for the company but at least ensures that the patients are not exposed, in this case, to possibly deadly side effects. After a recall the manufacturer must also develop a Risk Evaluation and Mitigation Strategy, which also has to be approved by the FDA, to ensure patient and medical practitioners are fully informed about the risks of the product.
ReplyDeleteThere are still drugs in circulation that are known to cause PML and not every company recalled them. Genetech did the right thing with this recall and proved a mature and ethical attitude towards patients.