New medication for MS, Tecfidera (BG-12), Approved by FDA

March 28, 2013 James D. Bowen, M.D.

On March 27, the U.S. Food and Drug Administration approved the newest treatment in the increasing number of disease modifying therapies (DMTs) available to treat multiple sclerosis. Tecfidera (BG-12) is an oral capsule to treat adults with relapsing forms of MS. Research participants at the MS Center at Swedish participated in clinical trials for Tecfidera.


The trials reported that people taking Tecfidera had fewer relapses and less frequent worsening of disability compared to people taking a placebo. There were also fewer and less-severe side effects with Tecfidera than other treatments.


The studies found that Tecfidera may decrease white blood cell count, which may increase risks for infections. Providers should check white blood cell levels before starting treatment with Tecfidera and once a year after. It may also cause flushing, nausea, vomiting and diarrhea that may decrease over time on the drug.


One important note is that although Tecfidera is now FDA-approved, it will take a few weeks for pharmacies to stock the medication. Patients should also consider that it may also take a few weeks for insurance companies to decide how they will bill for Tecfidera.


As with all new medications, patients should consult with their health care provider about any changes to their treatment plan. Each person’s disease course is different. Working closely with a team of providers puts a person in the best position to achieve their highest well-being with the disease.


For more about Tecfidera, check out the February edition of MS HelpLines.

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