Underdosed generic specialty medications: A prescription for patient harm?

The use of generic specialty medications amongst individuals with multiple sclerosis (MS) has expanded due to an increase in the number of available agents. We describe a woman who was denied continued use of brand name teriflunomide (Aubagio ^Ⓡ ), despite being clinically stable for 2.5 years, and switched to generic teriflunomide. She experienced a significant spinal cord exacerbation within a few months of starting treatment. We analyzed 3 generic teriflunomide agents, including the one used for treatment, in addition to Aubagio ^Ⓡ . The generic teriflunomide used by our patient contained 55.5 % content of the labeled amount, well below U.S. FDA specifications.
Competing Interests: Declaration of competing interest D.T.O. received personal compensation for consulting and advisory services from Biogen, Eisai, EMD Serono, Genentech, Genzyme/Sanofi, Moderna, RVL Pharmaceuticals, Inc., Zenas Biopharma, and research support from EMD Serono/Merck, and Novartis. Dr. Okuda has issued national and international patents along with pending patents related to other developed technologies. Dr. Okuda received royalties for intellectual property licensed by The Board of Regents of The University of Texas System. Dr. Okuda is the Founder of Revert Health Inc. K.W.B., T.M.M., and M.A.P. report no disclosures.
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