FDA requires rare eye-condition warnings for drugs including Ozempic and Zepbound

The U.S. Food and Drug Administration is requiring makers of drugs including Ozempic and Zepbound, used for diabetes or weight management, to add warnings about a rare eye condition that can cause permanent vision loss.^[1]

The supplied report does not identify every affected product, a deadline for adding the warnings or the condition's specific frequency.^[1]

Manufacturers must update safety information, giving doctors and patients another factor to weigh against treatment benefits. If the warning leads some patients to delay starting treatment or doctors to choose alternatives, prescription volumes and sales growth for affected medicines could face pressure. The report does not establish that prescribing or sales have changed, or provide enough detail to estimate the impact.^[1]

Impact

• Diabetes and weight-loss medicinesRisk

  Makers of affected medicines must revise safety information. Whether competitors gain depends on doctors switching treatments and whether alternatives also fall under the warning requirement; the report does not establish its full scope.^[1]