U.S. drug regulators have warned people against using amniotic fluid-containing eye drops because they are not approved for use in the United States.
Regardless, some companies advertise and sell amniotic fluid eye drops, claiming to treat, reduce, or cure problems such as dry eye disease.
“Currently, there are no FDA-approved amniotic fluid eye drops to treat, alleviate, or cure eye diseases and conditions. is needed,” the U.S. Food and Drug Administration (FDA) said in an April alert.
“Furthermore, because these products are not FDA-approved, the FDA does not have information regarding their manufacture, and there is no assurance that the products are safe or effective for any disease or condition.” the agency said.
According to the FDA, the promotion and distribution of the product “raises potential serious safety concerns.”
Regulators have tried to crack down on companies selling eye drops without FDA approval. In late 2022, they sent letters to M2 Biologics LLC and Regener-Eyes LLC. The two manufacturers advertise their unapproved products as being able to treat dry eye disease.
However, products sold by businesses can still be ordered from various websites on the Internet. Both companies did not respond to requests for comment.
The FDA recommends that anyone considering using amniotic fluid eye drops should take steps to see if the product is FDA-approved.
“Ask if the FDA has reviewed the treatment. You can also request an FDA-issued Investigational New Drug Application (IND) number and an opportunity to review FDA communications that the IND is in effect.” said the FDA. “Ask for this information before receiving treatment and follow up with your personal health care provider to verify this information.”
Amniotic fluid is the substance that envelops the embryo and fetus during pregnancy.Liquid could potentially help heal eye problems, researchers say SaidHowever, clinical trials examining amniotic fluid eye drops Conclusion The drops did not improve healing or reduce pain.
Professor Paul Nofler of the University of California, Davis said: MedPage Today The product may contain substances that may be harmful to your eyes.
“The drops likely contain hundreds of different fetal proteins and other substances that don’t necessarily do anything beneficial, so there are distinct risks.” I could only imagine the risk of abnormal blood vessels and other unwanted tissue growth after using such eye drops due to the growth factors released.”
Healthcare providers are instructed to report adverse events related to the use of amniotic fluid eye drops and other products regulated by the FDA to a system called the FDA Adverse Event Reporting System. med watchConsumers can also submit reports to the system.
