FDA Issues Warning on Amniotic Fluid Eye Drops

Agency says products have not been approved
By Rob Quinn,  Newser Staff
Posted Apr 27, 2023 1:14 PM CDT
FDA: Don't Put Amniotic Fluid in Your Eyes
Stock photo.   (Getty Images/Hopfphotography)

Amniotic fluid—the fluid that surrounds a fetus in the womb—is among the many things that you shouldn't put in your eyes, the Food and Drug Administration says. In a notification issued earlier this month, the agency said manufacturers are "marketing and distributing amniotic fluid eyedrops" for conditions like dry eye disease "without the required premarket review and approval, raising potential significant safety concerns." The agency said the notification was prompted by the online sale of products supposedly containing the fluid, LiveScience reports.

The agency said there are no FDA-approved amniotic fluid products, plus "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 the early weeks of pregnancy, the fluid "contains a variety of maternal and fetal excretions and secretions," per Ars Technica, but it is mostly fetal urine after about 10 weeks. Some researchers have argued for years that amniotic fluid can promote eye healing, but the only clinical trial that has been published found that it was no better than a placebo, Ars Technica reports.

The FDA said it wrote to two companies last year to warn them that the eye drops they were selling would need a valid biologics license to stay on the market. The warning is part of a wider FDA crackdown on companies advertising "birth tissue" treatments. "The problem with such commercial activity is that such companies haven't tested their products in controlled clinical trials and the safety and efficacy of such amniotic fluid products in the treatment of individuals with dry eye disease and other diseases have not yet been established," Leigh Turner, executive director of the bioethics program at the University of California Irvine, tells MedPage Today. "These untested or inadequately tested products pose risks to patients." (Read more eyedrops stories.)

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