All drugs have risks. May of those risks show up in the clinical studies conducted in the support of NDA or BLA approvals and are placed into labeling in the original labeling approved for the product. Remember, clinical studies are of various sizes, some small and some large. However, none of the clinical studies conducted can always identify the very rare conditions that are only seen in patients during the post-approval period when the product is used in the general population. When the drugs are being used by millions of patients, a 1 in a million adverse drug event (ADE) might become evident. Historically, serious adverse events may not be recognized until a product has been marketed for years.
While these products are relatively new, their uptake has been wide and fast and as a result of postmarketing ADE data and evaluation of other information, “[T]he U.S. Food and Drug Administration is informing patients and health care providers of a potential increased risk of non-arteritic anterior ischemic optic neuropathy (NAION) associated with use of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications. NAION is a rare condition that can result in acute, painless, decreased vision in one eye, including permanent vision loss”.
This warning will be added to the Warnings and Precautions section of labeling for all GLP-1 receptor agonists. Additional information on the warning and a review of the data the FDA evaluated to inform its decision to add the warning along with a list of all approved GLP-1 RAs products may be found here.
