October 23, 2014
Biogen Idec reports case of progressive multifocal leukoencephalopathy (PML) in an individual in Europe who received Tecfidera
Pharmaceutical company Biogen Idec reported a case of progressive multifocal leukoencephalopathy (PML) - a rare and generally fatal brain disease - in an individual in Europe who had received Tecfidera* (dimethyl fumarate) for the treatment of multiple sclerosis. The patient was enrolled in the ENDORSE study, an extension clinical trial evaluating the long-term effects of treatment with Tecfidera in people with MS. The patient had been taking Tecfidera for four and a half years when they exhibited reduced blood cell counts – known as lymphopenia, a known adverse effect of this treatment. The patient was diagnosed with PML and later died from complications associated with pneumonia.
Biogen Idec is working with the relevant regulatory authorities
to confirm that the language on Tecfidera’s label provides those
using the treatment and their healthcare team the appropriate
information. People who are taking Tecfidera as a treatment
for multiple sclerosis are advised to maintain ongoing
consultation with their physicians. The MS Society recommends
that people taking or considering Tecfidera to contact their
prescribing physician if they have any questions about
Tecfidera’s safety. As well, this emphasizes the importance of
patient monitoring before and during treatment with Tecfidera,
which is clearly stated in the Health Canada drug
Individuals taking Tecfidera are also encouraged to report suspected side effects to Health Canada’s Canada Vigilance Program at 1-866-234-2345 or through their website. Other questions related to treatment with Tecfidera can also be directed to the Biogen Idec ONETM program at 1-855-MSONE-00 or 1-855-676-6300.
*Tecfidera is a registered trademark of Biogen Idec