Manufacturers are marking and distributing eye drops with amniotic fluid to treat or cure diseases and conditions without federal approval, "raising potential significant safety concerns," according to the Food and Drug Administration (FDA).
The FDA issued a notice earlier this month telling patients and health care practitioners that the agency hasn't approved any amniotic fluid eye drops to treat, mitigate or cure eye diseases or conditions such as dry eye to date.
"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," the FDA said.
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These eye drops contain amniotic fluid, which is a clear, slightly yellowish liquid that surrounds an unborn baby during pregnancy, according to the Mount Sinai Health System.
In order for a health care provider to offer such products, "there must be an investigational new drug application in effect," federal health officials said.
The FDA in 2022 issued letters to manufacturers that are marketing this product without FDA review or approval.
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Patients who are seeking treatment with amniotic fluid eye drops need to ask if the FDA has reviewed the treatment, health officials said.
The FDA also suggests that patients 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.
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"Ask for this information before getting treatment and follow up with your personal health care provider to confirm this information," the FDA said.
