The Food and Drug Administration (FDA) has recently issued a notice warning patients and health care practitioners about the dangers of using eye drops containing amniotic fluid to treat or cure eye diseases or conditions such as dry eye. The FDA has not approved any amniotic fluid eye drops to date, and the agency is concerned that manufacturers are distributing these products without federal approval, potentially causing significant safety concerns. Amniotic fluid is a clear, slightly yellowish liquid that surrounds an unborn baby during pregnancy.
The FDA has stated that as these products are not FDA-approved, the agency does not have information about their manufacture, and there are no assurances that the products are safe and effective for any disease or condition. In order for a health care provider to offer such products, there must be an investigational new drug application in effect. The FDA issued letters to manufacturers that are marketing this product without FDA review or approval in 2022.
The FDA also warns that patients seeking treatment with amniotic fluid eye drops need to ask if the FDA has reviewed the treatment. Patients should ask for the FDA-issued investigational new drug application number and the chance to review the FDA communication stating that the IND is in effect. Patients should ask for this information before getting treatment and follow up with their personal health care provider to confirm this information.
The FDA’s warning is in response to safety concerns raised by the use of these eye drops, and the potential risks associated with their use. Patients and health care practitioners should be aware of these safety concerns, and patients should seek medical advice before using any unapproved treatments for their conditions.