Tysabri Problems Continue; Now 13 Reports of Brain Infection, FDA Says
The Food and Drug Administration just announced that reports of users of the multiple sclerosis drug Tysabri developing a rare but deadly viral brain infection continue to pour into the agency.
Tysabri, which is made by Biogen Idec Inc. and Elan PLC and first approved in 2004, has been linked to 13 cases of progressive multifocal leukoencephalopathy (PML) worldwide since the drug was reintroduced in July 2006, the FDA said. Tysabri was briefly ordered after the market soon after it was launched, then allowed back in circulation with tougher warnings about the risks of developing PML.
In July, the FDA said there had been 11 cases of PML in Tysabri users, so today’s announcement means the FDA has received two more reports of the disease since then. Of the now 13 cases, four were reported among patients in the United States, the FDA said.
Tysabri is used to treat relapsing forms of multiple sclerosis and moderate to severe cases of Crohn’s disease, a form of irritable bowel syndrome. While the drug is also approved for treating Crohn’s disease, none of the PML cases have been reported in patients taking the drug for that condition. Less than two percent of Tysabri use in the United States is for treating patients with Crohn’s disease, officials said.
There are still as many as 43,000 patients taking Tysabri, including more than 30,000 who have been taking it for more than a year and another 10,000 who have been on it for more than three years, according to a report in The Wall Street Journal.
In April, federal regulators slapped Biogen for misleading on-line advertisements for Tysabri which touted the benefits of the drug without emphasizing the potential risks, including PML.
And just last week, researchers said Tysabri puts patients at greater risk of developing PML by awakening the virus that causes the disease and making the virus even stronger, according to a new study.
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