Drug Companies Also State There Have Been No Reports Of Other "Serious Opportunistic Infections" Related To Recent Use Of Tysabri
(Posted by Tom Lamb at DrugInjuryWatch.com)
In a May 3, 2007 Wall Street Journal (WSJ) article, Jennifer Corbett Dooren gave us an update of the safety profile of the multiple-sclerosis drug Tysabri:
There have been no additional reports of a serious brain infection known as progressive multifocal leukoencephalopathy, or PML, among patients taking the multiple-sclerosis drug Tysabri, the drug's makers said Thursday.
Biogen Idec Inc. and Elan Corp., also said there were no reports of other "serious opportunistic infections," as of April 23. The companies released the first safety update involving Tysabri since the drug was allowed back in the U.S. market last June. The data was released at the American Academy of Neurology's annual meeting on Boston.
The finding was among new data on Tysabri's safety and efficacy reported at the annual meeting of the American Academy of Neurology, and was the subject of a May 3, 2007 press release issued by Biogen Idec.
As background, Tysabri was withdrawn from the U.S. market in February 2005 after two patients developed progressive multifocal leukoencephalopathy (PML) and one died. A third patient was later discovered to have PML and also died.
In June 2006 the FDA allowed Tysabri to return to the U.S. market under certain restrictions which include a prescribing program that allows the companies to track potential safety problems with Tysabri.
Returning to the May 3, 2007 WSJ article for more information about the current Tysabri program:
The companies said about 12,500 patients world-wide have been prescribed Tysabri, including about 6,600 patients in the U.S. currently who are on therapy.
The companies said about 10,000 U.S. patients and 1,500 physicians have enrolled in the restricted distribution program known as Touch....
Before Tysabri can be started, patients must undergo a magnetic resonance imaging or MRI scan to differentiate potential future multiple sclerosis symptoms from PML. Patients would then be evaluated at three months, six months and then every six months after that. The status of those evaluations must be reported by doctors to Biogen Idec.
We will continue to watch for reports of adverse drug reactions involving Tysabri as more patients gain access to this controversial multiple-sclerosis drug.