Psoriasis Medication Removed from U.S. Market After Link to Brain Infection

By April 9, 2009Dangerous Drugs

Pharmaceutical company Genentech announced April 8 that it would remove its drug Raptiva (efalizumab) from the market for safety reasons. Raptiva is an injectable medication given weekly to patients who have psoriasis, a chronic skin condition. According to Forbes magazine, the move came almost two months after the U.S. Food and Drug Administration confirmed the medication’s link to a rare but deadly disease called progressive multifocal leukoencephalopathy, a viral infection of the brain. Patients using Raptiva are strongly encouraged to contact their doctors right away to discuss alternative treatments.
Ironically, the problems with Raptiva may stem from its effectiveness. Psoriasis is a chronic, lifelong condition that produces raised patches of scaly or inflamed skin. Doctors are not sure what causes it, but many believe it’s an autoimmune disorder in which an overactive immune system produces too many skin cells. Raptiva addresses the problem by partially suppressing the immune system — stopping white blood cells from reaching tissues. Because of the suppressed immune system, Raptiva carries a risk of side effects including infection with viral meningitis and fungal disease.
Most recently, the FDA has discovered that it also raises the risk of progressive multifocal leukoencephalopathy (PML), a disease caused by infection with a common virus. Authorities believe most people have this virus, but it is latent in people with healthy immune systems. The most likely victims are people with immune problems, such as AIDS, or who are on immunosuppressant drugs after a transplant. PML inflames the white matter of the brain, destroying the myelin sheath on nerve cells and causing weakness, paralysis, blindness, speech impairments and eventually death. It resembles multiple sclerosis, but progresses much more quickly. There is no known cure.
Thus far, the FDA has identified two confirmed cases of deaths from PML in Raptiva patients, and suspects PML in a third death. A fourth patient has PML but has not died. Since October of 2008, the agency has revised the drug’s labeling twice and issued a public advisory once on the risk of PML. During that time, the European Union’s equivalent to the FDA has suspended all sales of the drug. Genentech is working with other regulatory agencies to inform them about Raptiva’s withdrawal from the U.S. market, but it has not stopped worldwide sales. According to Forbes, 46,000 people around the world have used Raptiva since 2003.
I applaud Genentech for doing the right thing and withdrawing this potentially deadly medication from the market. But as a dangerous prescription drug attorney, I wonder how long the company has known about this risk and what measures it took to detect it. Accidents happen, but I know that some drug companies are willing to suppress unfavorable safety information or manipulate scientific studies to ensure that their sales stay high. If investigation shows that Genentech knew about the risk, or even failed to do adequate testing, the manufacturer would be legally liable for all of the deaths and deadly illnesses that resulted. That could mean millions of dollars’ worth of defective prescription drug lawsuits.
Based in St. Louis, the Lowe Law Firm handles dangerous pharmaceutical legal claims throughout the United States. Our defective drug lawyers represent people who have lost a loved one or been seriously hurt because they trusted the wrong prescription drugs. If you are in this situation and you’d like to learn more about your options, we offer free, confidential consultations. To set one up, please contact the Lowe Law Firm online today or call 1-877-678-3400.