Skip to main content

FDA says don't use eye drops with amniotic fluid

The Food and Drug Administration issued a warning that amniotic fluid eyed rops haven't been approved to treat or cure diseases and conditions, raising safety concerns.

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. 

EYE DROPS RECALLED OVER NON-STERILITY: FDA

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. 

FDA WARNS ANOTHER EYE PRODUCT COULD BE CONTAMINATED WITH BACTERIA AMID OUTBREAK OF INFECTIONS

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. 

GET FOX BUSINESS ON THE GO BY CLICKING HERE

"Ask for this information before getting treatment and follow up with your personal health care provider to confirm this information," the FDA said. 

Data & News supplied by www.cloudquote.io
Stock quotes supplied by Barchart
Quotes delayed at least 20 minutes.
By accessing this page, you agree to the following
Privacy Policy and Terms and Conditions.