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  4. Public Safety Notification on Amniotic Fluid Eyedrops
  1. Safety & Availability (Biologics)

Public Safety Notification on Amniotic Fluid Eyedrops

FDA Safety Communication – April 10, 2023

Purpose:  To inform the public, including patients and health care practitioners, that manufacturers are marketing and distributing amniotic fluid eyedrops to treat, mitigate, or cure diseases or conditions such as dry eye disease without the required premarket review and approval, raising potential significant safety concerns.

Background:  As a general matter, amniotic fluid eyedrops used to treat diseases and conditions in humans are regulated as drugs and biological products under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act and are subject to premarket review and approval requirements. 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. 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.

Information for Health Care Professionals:  Health care professionals should report any adverse events related to the use of amniotic fluid eyedrops or other FDA-regulated products to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178. FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.

Information for Patients and Consumers:  Patients and consumers considering treatment with amniotic fluid eyedrops products in the United States should:

  • Ask if the FDA has reviewed the treatment. You also can ask for the FDA-issued Investigational New Drug Application (IND) number and the chance to review the FDA communication stating that the IND is in effect. Ask for this information before getting treatment and follow up with your personal health care provider to confirm this information.
  • Request the facts and ask questions if you don’t understand. To participate in a clinical trial that requires an IND application, you must sign a consent form that explains the investigational procedure. The consent form also identifies the Institutional Review Board (IRB) that assures the protection of the rights and welfare of human subjects. Make sure you understand the entire process and known risks before you sign. You also can ask the study sponsor for the clinical investigator’s brochure, which includes a short description of the product and information about its safety and effectiveness.
  • Report any adverse events related to the use of amniotic fluid eyedrops or other FDA-regulated products to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178. FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.

FDA has taken steps to notify manufacturers marketing amniotic fluid eyedrops regulated as drugs and biological products without FDA review or approval.  The agency issued two untitled letters in late 2022 to manufacturers of these products that are available on the FDA website.

FDA remains committed to protecting patients from unapproved and unproven products and to working with those who share our goal of bringing safe and effective products to market to benefit individuals in need.

 

 
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