Psoriasis Drug Raptiva Banned in Canada; U.S. and Europe May Follow Suit

Raptiva, the drug used for treatment of the skin condition psoriasis that has been linked to a rare but deadly brain infection, has been banned by Canadian health officials. The move is just the latest in a string of blows for the controversial drug that also is facing increased scrutiny in Europe and the United States.

The U.S. Food and Drug Administration recently launched an investigation into a possible link between Raptiva and progressive multifocal leukoencephalopathy (PML). There have been a handful of reported cases of the life-threatening brain infection in people taking Raptiva, including some fatal cases.

Officials with the European Medicines Agency have also recently indicated that they are considering banning the use of Raptiva in Europe. A final decision on whether or not Raptiva will remain available in Europe could be made soon.

Raptiva, approved in the U.S. in 2003, is a therapeutic antibody designed to block T-cells which lead to the severe and painful skin inflammation called psoriasis. The drug is administered once a week through a shot and can be self-administered by patients at home. The drug fights psoriasis by lowering the body’s immune system, but in doing so, it can also expose patients to deadly infections, such as PML.

In the U.S., Raptiva’s packaging contains a prominent “Black Box” warning to advise physicians and patients about the risks of PML in people taking the drugs. However, tougher restrictions of the drug may be advisable given the recent patient deaths and injuries.

Raptiva Risks Outweigh Benefits

Raptiva, made by Genentech, was approved in Canada in 2005 for use in adults suffering from moderate to severe chronic psoriasis. There are currently about 500 people in the country taking the drug, Canadian officials said.

Canadian physicians have now been advised to stop prescribing Raptiva and evaluate patients taking the drug to determine the best course of action. In some cases, it may be best to stop taking the drug and begin treating psoriasis with another drug or form of treatment.

Although some psoriasis patients have benefited from therapy with Raptiva, within months, the drug will be out of circulation in Canada, officials said.

Fatal PML Cases Reported

There have been at least three confirmed PML-related deaths of Raptiva patients, officials said. Reports of those deaths prompted the Canadian ban and forced U.S. and European health officials to take a closer look at Raptiva.

PML is caused by a virus which affects the central nervous system. The infection usually occurs in people whose immune systems have been severely weakened, such as AIDS patients or patients taking immune-suppressing drugs. Still, it relatively rare, affecting about one in every five AIDS patients, officials said.

PML is a progressive disease which causes an irreversible and worsening decline in neurologic function and eventually death. Symptoms of the disease may include unusual weakness, loss of coordination, difficulty seeing or speaking, and unexplained personality changes. There is no known effective prevention or treatment for PML.

U.S. Must Proceed Carefully With Raptiva

Canadian officials are now in the lead by taking a firm and cautious approach to Raptiva. Officials in the U.S. and Europe must continue to closely monitor Raptiva and ensure that patients are not being exposed to an unreasonably high risk of PML and other injuries. The health and safety of consumers must be the paramount concern for the Food and Drug Administration.

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