Tysabri: Multiple Sclerosis Medication Linked to 13th Brain Infection Case

David Mittleman — Tue, 30 Jun 2009 13:02:55 GMT

Biogen Idec Inc., a biotechnology company, announced Friday that another patient who was taking its Tysabri multiple-sclerosis medicine is infected with progressive multifocal leukoencephalopathy, or PML. Their announcement marks the 13^th case of the infection in patients taking Tysabri. Three other patients have already died from taking the medication and contracting PML. PML is a serious brain infection that attacks the central nervous system and damages and inflames the white matter areas of of the brain. Immune suppressing drugs such as Tysabri put patients at serious risk for contracting PML and potentially dying as a result.

Tysabri was pulled from the market back in 2005 after three initial cases of PML were discovered. After holding hearings on the drug’s risks and benefits, the Food and Drug Administration allowed Tysabri back onto the market in 2006 under new monitoring rules that the drug could not be combined with other MS drugs. The FDA had hoped that the new regulations would reduce the incidence of PML cases, but there have been ten new cases since.

Several other immune suppressing drugs have also contributed to the incidence of PML. In fact, Roche Holding AG pulled its psoriasis drug, Raptiva, over reports of PML. Similarly, Roche and Biogen has also come under increased scrutiny from the FDA over reports that its cancer treatment, Rituxan, increases the likelihood of contracting PML.

Originally posted at InjuryBoard by David Mittleman

Raptiva Puts Patients At Risk For PML

David Mittleman — Mon, 02 Mar 2009 15:37:16 GMT

Patients taking the Genentech product, Raptiva, for psoriasis are being warned by the Food and Drug Administration (FDA) about the risk of developing a rare brain infection. A fourth possible report of progressive multifocal leukoencephalopathy (PML) has yet to be confirmed. Three out of the four instances have ended in death, and each patient had been taking the medicine for more than three years.

The FDA is now doing a cost-benefit analysis to ensure that the risks of Raptiva do not outweigh the rewards; that patients prescribed Raptiva are clearly informed about the symptoms of the disease; and that doctors carefully monitor patients for the possible development of the brain infection.

PML is caused by a virus that affects the central nervous system and usually occurs in people whose immune systems have been severely weakened. It leads to an irreversible decline in neurologic function and death. Symptoms may include unusual weakness, loss of coordination, changes in vision, difficulty speaking and personality changes. Treatment or effective methods of prevention are not known.

Psoriasis, on the other hand, has a number of effective treatments including ultraviolet light therapy, and the drugs cyclosporine, acitretin, and methotrexate, Raptiva, and four other biological agents. The treatment of psoriasis usually involves a combination of therapies over time.

Raptiva is approved for adults with moderate to severe plaque psoriasis. The medication suppresses the T-cells in the blood which help fight infection. These cells migrate to the skin in patients with psoriasis, causing inflammation which results in the red, inflamed and scaly patches of skin, which is associated with the disease. Because these cells are suppressed by the medication, the body becomes more susceptible to infections

The FDA strongly recommends that doctors closely monitor those who are now taking, as well as those who have discontinued use of Raptiva for any signs or symptoms of PML. Patients should be aware of the symptoms of PML and contact their doctor immediately if they experience the above mentioned symptoms.

Originally posted at InjuryBoard by David Mittleman

Michigan Personal Injury Blog - PML

Tysabri: Multiple Sclerosis Medication Linked to 13th Brain Infection Case

Raptiva Puts Patients At Risk For PML