FDA adds rare vision loss warning to Ozempic, Mounjaro and similar drugs

The US Food and Drug Administration (FDA) has required manufacturers of all GLP-1 receptor agonist drugs—including Ozempic, Wegovy, and Mounjaro—to add a warning to their prescribing information about a possible increased risk of a rare but serious eye condition that can lead to permanent vision loss.

In a drug safety statement issued Monday, the FDA said the condition, known as non-arteritic anterior ischemic optic neuropathy (NAION), results from reduced blood flow to the front of the optic nerve and causes sudden, painless vision loss in one eye.

Drugs included

The warning covers 12 approved medications, most notably Ozempic and Wegovy (semaglutide), Rybelsus (semaglutide), Mounjaro and Zepbound (tirzepatide), Saxenda and Victoza (liraglutide), Trulicity (dulaglutide), and the newly approved Foundio (orforglipron) this year.

These drugs are widely used to treat type 2 diabetes and for weight loss, as well as for other approved uses such as reducing the risk of heart and kidney disease.

What the data showed

The FDA analyzed 126 clinical trials involving more than 134,000 patients. The analysis found an incidence rate of 6.4 cases per 100,000 people per year among users of these drugs, compared to 3.8 cases among those receiving a placebo or other diabetes medications.

The agency noted that the incidence of this condition among adults over 50 in the general population ranges from 2.3 to 10.2 cases per 100,000 people per year. It also pointed out that risk factors such as diabetes, high blood pressure, and sleep apnea overlap with common conditions in users of these drugs.

The FDA said it has observed cases with all drugs in this class currently on the market and concluded there is a "potentially increased risk" of this rare condition.

Symptoms and patient recommendations

The FDA urged patients to contact their doctor immediately if they experience any of the following symptoms:

- Sudden, painless vision loss in one eye, which may be noticed upon waking.

- Blurred vision or missing areas of vision, such as blind spots or tunnel vision.

- Changes in color perception.

- Reduced central visual acuity.

Patients diagnosed with this condition should discuss with their doctor whether to continue or stop the medication. The FDA also advised healthcare providers to refer suspected cases to an eye specialist and to consider discontinuing the drug unless its benefits clearly outweigh the risks.