In December 2014 the FDA added warnings of PML, lymphopenia, anaphylaxis, and angioedema to Tecfidera’s drug label according to the ms-coalition.org. PML is a serious brain infection that causes death or severe disability. One PML death has been linked to Tecfidera with the patient suffering from lymphopenia for 3.5 years of the 4.5 years of treatment – lymphocyte count was <0.5. Lymphopenia is a drop in lymphocyte count which is a form of white cell and is part of the immune system.
Anaphylaxis is an allergic reaction and angioedema is swelling often around the lips and eyes. Pictures of such reactions might be a little too frightening to put on my blog. These reactions can happen at any time while on the medication. I am just waiting to see the company add hair loss to the side effects as I sit here missing a significant amount of hair I had just 11 months ago when I began the medication. Also in the update is a dosage change to 120 mg twice daily for one month to assist those struggling with side effects.
For a full run down on the updates for Tecfidera check out: http://ms-coalition.org/emergingtherapies/images/emergingtherapies_tecfidera_update12112014_clinicians.pdf. Image from: www.williamson-county.org.