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Underdosed generic specialty medications: A prescription for patient harm?
Darin T Okuda1, Katy W Burgess1, Tatum M Moog1
1The University of Texas Southwestern Medical Center, Department of Neurology, Neuroinnovation Program, Multiple Sclerosis & Neuroimmunology Imaging Program, Dallas, TX, USA; The University of Texas Southwestern Medical Center, Peter O'Donnell Jr. Brain Institute, Dallas, Texas USA.
Abstract:
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.
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