Raptiva Linked to Deadly Brain Infection

Raptiva, a drug that erases the red and scaly patches of psoriasis by tamping down the immune system, is the subject of a public health alert issued by the FDA in February 2009, after the agency received reports of three deaths and a possible fourth.

Several Long Island doctors are urging caution about a potent psoriasis drug linked to a deadly brain infection, as a report in a major medical journal today encourages more conservative prescribing for all medications.

Letters have been sent to physicians nationwide in recent weeks, cautioning them about the unusual side effect. The deaths have occurred within the past six months.

All affected patients developed a rare brain infection that led to a condition known as progressive multifocal leukoencephalopathy, PML. It is caused by a pathogen known as the JC virus, which infects 70 to 90 percent of the population. It can be lethal in some people taking immune-lowering drugs.

Dr. Richard A. Clark, professor of dermatology at Stony Brook University Medical Center, said he questions why patients with a disorder that isn’t lethal should take a drug that increases the risk of death.

“I never prescribed it,” Clark said yesterday. “But I’ve certainly cared for patients who were on it, usually placed on it by a rheumatologist. And I have encouraged all patients on it to stop. The last patient who was on it came off two or three weeks ago.”

Clark acknowledged his stance on Raptiva is not representative of the opinions among all members of the dermatology team at Stony Brook.

Yet Dr. Sari Beth Weinstein, a clinical instructor in dermatology at NYU School of Medicine, is equally concerned about Raptiva. In private practice in Greenvale, Weinstein said Raptiva is not a drug that can be stopped abruptly because of a phenomenon called “rebound and flare.”

“Right now, I don’t have any patients on it,” Weinstein said. “This is not my drug of choice. But if I did [prescribe it] I would talk to patients about transitioning to another medication.”

Psoriasis is an autoimmune disorder in which the immune system constituents known as T-cells attack the skin. Raptiva, a Genentech product, controls T-cell activity. Raptiva was FDA-approved in 2003 but carries a “black box” warning, the agency’s highest level of caution.

Dr. Bruce Bebo, research director at the National Psoriasis Foundation, said he’s not cautioning against the drug’s use. “There are risks and benefits to all treatments for psoriasis and individuals have to weigh the risks and benefits of the drug in conversations with their health care providers,” he said.

Drs. Gordon Schiff and William Galanter, writing in  the February 26, 2009, Journal of the American Medical Association, said physicians should view all medications with skepticism and embrace the term “just say no,” rather than writing prescriptions. Clark agrees. “I don’t want to come across as an alarmist, but I think we need to minimize risk in our patients as much as we can.”