FDA Warns of Unapproved Amniotic Fluid Eye Drops

FDA Warns of Unapproved Amniotic Fluid Eye Drops

April 26, 2023

The U.S. Food and Drug Administration (FDA) recently issued a safety communication warning against the use of amniotic fluid eye drops to treat dry eye disease. The FDA has found that some manufacturers are marketing and distributing these drops without the required premarket review and approval, which raises significant safety concerns.

Amniotic fluid eye drops are used to treat diseases and conditions in humans and are regulated as drugs and biological products under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. Currently, there are no FDA-approved amniotic fluid eye drops to treat, mitigate, or cure eye diseases or conditions. In order for a healthcare practitioner to offer these products to patients, there must be an investigational new drug application (IND) in effect.

The FDA has warned that the use of unapproved amniotic fluid eye drops could have serious consequences, including infection and blindness. The agency also notes that as these products are not FDA-approved, they have no information about their manufacture, and there are no assurances that the products are safe and effective for any disease or condition.

The safety communication is part of the FDA's ongoing efforts to battle against companies selling unapproved stem cell products. The agency has been issuing warning letters to companies and taking legal action against those who continue to market and distribute unapproved products.

The FDA advises patients with dry eye disease to talk to their healthcare provider about FDA-approved treatments and not to use unapproved products. Healthcare providers are also urged to ensure that they are only offering FDA-approved treatments to their patients.

According to the FDA, patients and consumers considering treatment with amniotic fluid eyedrops products in the United States should:

● Ask if the FDA has reviewed the treatment and for the FDA-issued IND number

● Understand the entire process and known risks before signing the consent form

● Request the clinical investigator's brochure for information about the product's safety and effectiveness

● Report any adverse events to the FDA's MedWatch Adverse Event Reporting program