European Regulators Review Arthritis Drug Safety as FDA Announces New Case of Brain Infection

By October 28, 2009Dangerous Drugs

Back in April, I wrote on this blog about the withdrawal of the drug Raptiva (efalizumab) from the market for safety reasons. That medication, intended for treating psoriasis, was implicated for weakening the immune system and allowing users to contract a rare brain infection called progressive multifocal leukoencephalopathy. Now, PML is back in the news in connection with two other drugs — Tysabri (natalizumab), a treatment for multiple sclerosis, and Rituxan (rituximab), which is for treatment of arthritis. The FDA is already watching both drugs for cases of PML. Now, the FDA has announced a new and slightly different case of PML in a patient taking Rituxan, and the European Medicines Agency, the EU’s FDA, is reviewing whether additional measures are necessary to make Tysabri safe.
The Tysabri review comes after 23 cases of PML were reported — about twice as many as were thought to exist before. The U.S. manufacturer, Boston’s Biogen Idec, said it was already considering a labeling change that would tell consumers that their risk of PML increases the longer they take Tysabri. Ironically, PML resembles a much faster form of multiple sclerosis, a degenerative disease that attacks patients’ movement, vision, speech and cognition. In MS, the body attacks myelin sheaths that protect nerve cells, but the sheaths can be replaced, causing the disease to progress slowly over a number of years. In PML, the cells that make the myelin are destroyed. As a result, PML progresses quickly, often killing its patients within a year of diagnosis.
While the effects of PML may be confused with the effects of MS in patients taking Tysabri, the problem is substantially less likely for patients taking Rituxan, which is indicated for rheumatoid arthritis. The FDA announced Oct. 23 that it had received a report of a new case of PML related to Rituxan, its third reported case. In this case, a 73-year-old woman received one course of treatment with the drug, then developed symptoms of PML within four to six months. This case is different from the previous two, the FDA said, because the woman had not previously been treated with a type of cancer drug called a TNF inhibitor. The FDA said “information to date suggests that patients with [rheumatoid arthritis] who receive Rituxan have an increased risk of PML.”
As a drug injury attorney, I hope that doctors are seriously reconsidering writing new prescriptions for Rituxan and Tysabri. Rheumatoid arthritis and MS are both serious, life-altering diseases, but this is a case where the cure may be even worse. Aside from AIDS patients, who can fight PML with newer drugs that restore their immune functions, patients diagnosed with PML are statistically likely to die within a year of diagnosis. Those who survive may live with severe neurological disabilities. This is a terrible fate and a terrible thing to watch a loved one go through. If the manufacturers originally understated this risk– or they negligently failed to examine it thoroughly — they could be legally liable in multiple pharmaceutical injury lawsuits from around the U.S. and the world.


Based in St. Louis, the Lowe Law Firm represents clients throughout the United States who were seriously injured by a prescription drug. That includes drugs whose manufacturers designed a drug that was never safe to begin with, suppressed negative scientific findings or illegally pushed it for off-label uses. Like all manufacturers, pharmaceutical companies are legally responsible for the safety of their products. When those products cause deaths or devastating permanent disabilities, victims may sue these manufacturers. Our dangerous drug lawyers help victims hold these manufacturers responsible for the costs of treating this new harm, other injury-related costs and compensation for lifelong disabilities or the irreversible loss of a loved one.
If you or a loved one was seriously harmed by a prescription drug that never should have been on the market, you should call the Lowe Law Firm right away. To learn more about your rights and your legal options, please contact us through our Web site or call 1-877-678-3400 toll-free.