People should not use eye drops marketed as if they contain amniotic fluid, the fluid that surrounds and cushions a developing fetus in the womb, the Food and Drug Administration (FDA) has warned. The sale of these eye drops, none of which have been approved by the FDA, raises "potential significant safety concerns," the agency wrote in a statement issued April 10.
As no eye drops of this description have been FDA-approved, any such eye drops would need to be prescribed under an investigational new drug (IND) application. In addition, the patient would have to sign a consent form acknowledging that the product was used under an IND application. However, the FDA's public safety notification was prompted by products being sold directly to consumers online, according to the agency's statement.
