FDA WARNING ON RAPTIVA (efalizumab)
Raptiva, a subcutaneous injection which is administered once a week for the treatment of severe psoriasis. Raptiva (efalizumab) is manufactured by Genentech, Inc based in Vacaville, CA with offices and manufacturing laboratory in Singapore. According to the advisory, the FDA has received reports of one possible and three confirmed cases of Raptiva users who were afflicted with a rare and debilitating brain infection known as Progressive Multifocal Leukoencephalopathy (PML). Of these four patients, three has already died. All four patients have been taking Raptiva for the last three years and have not taken any other treatment that supresses the immune system.
On February 20, 2009, the European Medicines Agency also formally suspended the sales of Raptiva after noting that the risks of PML brain infections among Raptiva users far outweigh the benefits provided by the drug. On the advise of Health Canada, Serono Canada, the company that markets Raptiva in Canada followed suit and stopped completely the sales of the controversial drug in that country!
The immediate and decisive responses of the European and Canadian health authorities on the Raptiva issue are unquestionably appropriate since PML brain infection is a deadly brain disease that has no known cure! By all indications, the PML brain infection is a side effect stemming from the continued use of Raptiva and is manifested by such symptoms as over-all weakness, vision loss, impaired speech, cognitive deterioration, and death.
The U.S. FDA is still closely weighing and studying the risks-versus-benefits scenario prior to any recall order for Raptiva. In the meantime, it has published a Raptiva advisory and slapped Genentech with a Raptiva label "blackbox" warning requirement - meaning every box of Raptiva that is sold in the market must contain a warning that says the use of the drug may entail the risk of acquiring life threatening infections like PML!
While in the meantime that Genentech and the FDA are still working closely together to properly address and minimize the risks of PML infection with Raptiva use, the drug continues to be sold freely in the U.S. and other parts of the world. And, the innocent, unknowing Raptiva users continue to be exposed to the threat of a brain infection!
If you have been using Raptiva, or if you happen to know anyone else who did and has experienced any of the manifestaions or symptoms of PML brain infections we mentioned above, you need to have your case reviewed immediately. You need to know your rights.
You need some real legal assistance to evaluate your Raptiva case before it becomes too late!