Genentech, the manufacturer of Raptiva (a drug designed to treat Psoriasis), announced a voluntary recall of the medication April 8, 2009. According to a statement issued by the U.S. Food and Drug Administration (FDA), Genentech decided to issue a Raptiva recall because of the risk to users of developing a fatal brain infection, progressive multifocal leukoencephalopathy (PML). The recall strongly advises all Raptiva users to stop treatment and all prescribers to work with patients on alternative treatment plans.
Raptiva will no longer be available in the U.S. after June 2009.
What is PML?
PML is a rare and potentially fatal infection that causes the white matter in the brain to swell. Affected individuals generally experience a change in vision, slurred speech, severe weakness, change in personality and other debilitating symptoms. Currently there is no cure for PML and most cases result in severe disability and death.
According to the FDA, the risk of patients developing PML following a Raptiva treatment is rare and has been linked to long-term use. However, in February, 2009 the FDA did confirm four cases of PML in Raptiva users, three of whom died. In response to the deaths, the FDA issued a Public Health Advisory Feb. 19, 2009, notifying healthcare professionals and Raptiva users of the potential health risk.
Since the FDA approved Raptiva (efalizumab) medication for use to treat Psoriasis (a skin condition in which scaly red patches form on the elbows, knees, scalp and genitals) in 2003, it has been linked to PML and other serious side effects. In fact, the FDA updated Raptiva’s labeling on Oct. 16, 2008, including a stronger warning of the list of side effects. And, on March 13, 2009, the FDA approved a Mediation guide for the drug and included more information about the Raptiva/PML link.
Other Raptiva Side Effects
In addition to PML, Raptiva has been linked to other serious conditions including:
- Bacterial sepsis
- Invasive fungal disease
- Viral meningitis
Genentech and the FDA strongly advise patients to stop their Raptiva treatments immediately and discuss an alternative Psoriasis treatment with their doctors. They have also asked prescribers not to administer any new Raptiva treatments.
(Source: FDA)
Have you or a loved one been harmed by a Raptiva treatment?
If so, you are eligible to seek compensation for your physical, emotional ad financial losses. For more information or to schedule a private, complimentary consultation with an Raptiva attorney, please contact us today.
