MS Drug Tecfidera More Trouble Than It’s Worth?
People with multiple sclerosis who take the MS drug Tecfidera may want to listen up. Others who are considering the medication should pay attention as well.
Why? At the recent joint meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis, experts presented a number of reports on the side effects associated with the use of Tecfidera (dimethyl fumarate). The findings are substantial enough to cause potential and current users of the drug to think about the findings.
Trouble with Tecfidera
More than 50 percent of patients who participated in an open-label study by the drug’s manufacturer (Biogen Idec) required over-the-counter (OTC) drugs to help manage diarrhea and stomach upset associated with Tecfidera. Among patients who kept taking the drug, the symptoms eventually resolved after two months. About 25 percent of patients who switched to Tecfidera after taking another MS drug stopped taking the drug completely within three months.
In a University of California Los Angeles study involving 30 patients, five (17%) stopped taking the drug because of gastrointestinal side effects (with one developing splenomegaly), 13 reported significant side effects (e.g., nausea, vomiting, bloating, and/or diarrhea), and 12 had minimal or no side effects. Another finding was that three patients who stopped taking Tecfidera had high eosinophil levels, which is an indication of infection.
A Lexington, Massachusetts study of 104 patients revealed that 57 percent experienced gastrointestinal symptoms during the first 30 days of treatment. By month three, 11 percent still had the problems.
In that same Lexington study, 51 percent experienced flushing during the first month of treatment, and that percentage was halved during subsequent months. In addition, 13 patients stopped treatment completely mainly because of GI adverse effects and 25 percent developed leukopenia or lymphopenia at month six.
Of the 66 MS patients who participated in a University of Texas Southwestern Medical Center study, only 18 percent suffered no side effects. The others experienced flushing (44%), GI symptoms (51%), or itching (12%). OTC medications such as aspirin, loperamide, antihistamines, and bismuth drugs were used to treat the side effects.
However, some patients suffered persistent problems and needed prescription drugs such as montelukast and glycopyrrolate. Overall, 26 percent of the patients stopped taking Tecfidera because of the side effects.
Biogen Idec funded several post-marketing studies of Tecfidera. One study of 233 patients found that 206 of the participants experienced a GI event during the four-month study and 126 required an OTC medication for the symptoms. Ten percent of the patients stopped treatment because of side effects.
In another Biogen Idec sponsored study, it was confirmed that up to 3.6 percent of patients who took the drug for 96 weeks developed lymphopenia. This is a condition characterized by low levels of white blood cells (lymphocytes) that fight infection.
Adverse events and other problems with medications such as the MS drug Tecfidera are often revealed after they hit the market. Postmarketing studies as well as reported experiences by patients can expose significant problems with these drugs.