PML and Psoriasis Patients
Psoriasis is a disease of the skin. It occurs when skin cells grow abnormally, resulting in thick, reddened, scaly and inflamed patches. The most common form of the disease, called plaque psoriasis, afflicts about 2.3 million Americans. It is characterized by reddened patches of skin with silvery white scales appearing on top of the lesions.
The disease may occur on only a few spots or may crop up extensively across the body. Its most common areas of appearance are on the scalp, knees, elbows and trunk. There are numerous medications that help to control psoriasis, but at present there is no cure.
Raptiva® to Treat Psoriasis
One drug, Raptiva® (generic is efalizumab), was being used to treat psoriasis, but was withdrawn from the U.S. and European markets early in 2009. Genentech, the drug maker, based its decision to pull the drug from the market on an association that was discovered between Raptiva® and a fatal brain disease called progressive multifocal leukoencephalopathy (PML). Genentech advised physicians to stop writing prescriptions for the drug and to contact patients receiving Raptiva® to transition them to new types of therapy for psoriasis.
At the time Genentech withdrew the drug from the market, the company estimated that about 2,000 patients in the U.S. were taking Raptiva® for chronic plaque psoriasis. Since its approval in 2003, Raptiva® had been prescribed for approximately 46,000 patients worldwide.
Raptiva® and PML
PML occurs in patients with compromised immune systems. It is caused by a virus, the JC virus (John Cunningham virus), that exists in a dormant state in more than 80 percent of adults. The virus remains harmless unless it is activated when the immune system becomes weakened. Once activated, the JC virus travels through the bloodstream to the brain, where it destroys the myelin, the protective covering surrounding nerve cells.
Myelin not only protects the nerve cells, it aids in their transmission of signals to the rest of the body. The virus progressively and relentlessly destroys parts of the brain, resulting in different areas of the body losing function. The first sign of the disease is usually clumsiness in its victims.
Other symptoms appear, including:
- Problems with speech and language, reading and writing
- Loss of cognitive function (being able to think and reason)
- Problems moving the arms and legs, especially on one side of the body
- Vision problems, usually in half the visual field
- Difficulty with sensation in different parts of the body
- Personality changes
Three patients who took Raptiva® were diagnosed with PML and one patient taking the drug had progressive neurologic symptoms, and died of unknown cause, according to Genentech.
"Our decision to remove Raptiva® from the market reflects Genentech's commitment to patient safety," said Hal Barron, M.D., Genentech's senior vice president of development and chief medical officer. "Although we believe that many psoriasis patients are benefitting from Raptiva®, the balance between benefit and risk in the psoriasis population for which Raptiva® was approved has significantly changed."
Were You Diagnosed with PML after Taking Raptiva®?
If you or someone you love has developed PML after taking Raptiva® or another medication, our PML attorneys may be able to help you seek financial compensation. To learn more about your rights, contact us for a free evaluation of your case. If your loved one dies from PML, we might be able to help you through a wrongful death suit.