The food and Drug Administration (FDA) issued a warning against eye drops which contain amniotic fluid, claiming that there remain many unresolved health concerns for products which use the unapproved stem cell product.
The FDA published a notice on April 10 in which the agency emphasized that they had not approved any eye drop product which used amniotic fluid, suggesting that there is a reasonable likelihood that such products could have unseen harms making them unsafe for human use.
“There are currently no FDA-approved amniotic fluid eyedrops to treat, mitigate or cure eye diseases or conditions, and in order for a health care practitioner to offer these products to patients, there must be an investigational new drug application (IND) in effect,” the agency said in a statement earlier this month. In addition, 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.”
Amniotic fluid is a clear, yellow-tinted fluid which surrounds an unborn baby in the womb. Somewhat disturbingly, none of the companies whose eye drop products list amniotic fluid as an ingredient have given an account of how this fluid was sourced for their products.
“The drops likely contain hundreds of different fetal proteins and other substances, which don’t necessary just do helpful things, so there are definite risks,” warned Dr. Paul Knoepfler in a statement to MedPage Today. “For example, I could imagine a risk of abnormal blood vessel or other undesired tissue growth in the eye after using such drops due to growth factors in the drops.”
Though the recent notice did not mention manufacturers by name, it follows letters to two manufacturers, StimulEyes and Regener-Eyes, in which the agency issued an ultimatum that the companies would need to apply for a Biologics License Application to stay on the market.
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