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EMA Confirms Very Rare Vision Loss Risk Linked to Semaglutide

Regulators now require semaglutide drug labels to warn of a very rare optic neuropathy that can cause sudden vision loss.

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Overview

  • The EMA concluded after a comprehensive review that semaglutide-containing drugs double the risk of non-arteritic anterior ischemic optic neuropathy in adults with type 2 diabetes.
  • The neuropathy is classified as a very rare side effect, affecting about one in 10,000 users per year.
  • The review drew on preclinical data, clinical trials, post-marketing adverse-reaction reports and scientific literature.
  • Manufacturers of Ozempic, Wegovy and Rybelsus must update labeling to include NAION as a very rare adverse effect.
  • Patients who experience sudden vision loss or rapid deterioration of vision must seek immediate medical attention.