Tecfidera and Death of Patient Likely Unrelated: Biogen

As an investigation continues into the death of a 59 year old woman who had been on the new multiple sclerosis medication Tecfidera, the drug’s manufacturer, Biogen Idec, Inc., has suggested that it does not believe there is a link between side effects of Tecfidera and the death.  

The unidentified woman reportedly died of pneumonia after taking Tecfidera for five and a half weeks. However, she stopped taking the drug two weeks before the death due to gastrointestinal problems, including nausea, vomiting and diarrhea.

According to a Reuters report, Biogen officials are gathering information on the death but indicate that it is unlikely Tecfidera played a role. The drug maker has suggested that the death does not appear to be related to gastrointestinal problems, as the woman died of pneumonia frequently associated with multiple sclerosis patients.

Tecfidera (dimethyl fumarate) was just introduced in March 2013 for treatment of multiple sclorsis (MS), and many expect the drug to become a blockbuster therapy. Stomach problems are among the known Tecfidera side effects.

MS causes the immune system to attack the body itself and can cause brain damage. It affects about 2.1 million people worldwide. A number of previous MS drugs, like Tysabri and Gilenya, have been linked to opportunistic infections because they suppress the immune system. Tecfidera also inhibits the immune system, and may also protect the brain and spinal cord from damage, but the exact mechanism for how the drug works is unknown.

One of the most dangerous side effects commonly linked to MS drugs is a rare brain disease known as progressive multifocal leukoencephalopathy (PML), which is believed to be caused by the common JC virus. Many suspect that the virus becomes active after drugs suppress the immune system. In many cases, the infection results in death.

Symptoms of PML can include mood changes, unusual behavior, confusion, memory loss, weakness or loss on one side of the body, or problems with vision, speech or walking. PML does not appear to have been a factor in the subject’s death.