FDA Orders Supernus to Stop Misleading Promotion of Oxtellar XR

November 10, 2016

The FDA’s Office of Prescription Drug Promotion is ordering Supernus Pharmaceutical to stop making misleading claims about the use and risks of Oxtellar XR.

According to an untitled FDA letter, a video from the specialty drugmaker minimizes the therapy’s risks and suggests that it’s indicated for epilepsy.

Oxtellar XR, however, is associated with serious risks that include hyponatremia, anaphylactic reactions and suicidal ideation. It’s indicated as an adjunctive therapy for partial seizures.

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