Adverse-Event Reporting for Emerging Products

If you feel seriously unwell, get urgent care first

Reporting is not emergency care and is not an emergency service. If you or someone else has a serious reaction after a treatment, product or procedure, get medical help first. In the United States, call 911. Tell the clinicians exactly what was given, when, and by whom, and take any packaging or paperwork with you. Report to a regulator afterward.

What MedWatch is

In the United States, MedWatch is the FDA's program for reporting serious reactions, product quality problems, therapeutic inequivalence or failure, and product use errors with human medical products. The FDA lists drugs, biologic products, medical devices, dietary supplements, infant formula and cosmetics. [1] Its MedWatch page says it receives reports from the public for FDA-regulated products including biologics such as gene therapies and human cells and tissue transplants, medical devices, cannabinoid hemp products such as those containing CBD, and cosmetics. [2]

Reporting is voluntary. The FDA says it relies on voluntary reporting to keep effective medical products on the market, and that a report may prompt a change in use or design of a product. [1] Consumers, patients and health professionals can use the online form, and there is a consumer-friendly paper version (Form FDA 3500B). [1] The FDA says your health care provider is not required to report, and that you may complete the online form yourself. [1]

For information or help, the FDA lists a toll-free line: 1-888-INFO-FDA (1-888-463-6332), press 2 to report into MedWatch or for instructions. [1]

Emerging and unapproved products

The FDA has said it has received reports of blindness, tumor formation and infections linked to unapproved regenerative medicine products such as stem cells, stromal vascular fraction, umbilical cord blood products, amniotic fluid, Wharton's jelly, orthobiologics and exosomes. [3] Its page tells U.S. patients treated with such products who were hurt or had a bad side effect to report to MedWatch, and invites them to contact the FDA at [email protected] if offered such a product outside an FDA-overseen trial. [3]

In a December 6, 2019 notice about unapproved products marketed as containing exosomes, the FDA described multiple reports of serious adverse events in patients in Nebraska, brought to the agency's attention by the CDC and others. [4] It asked health professionals and consumers to report any adverse events related to exosome products or any other unapproved product to MedWatch. [4]

For CAR T products, the FDA's April 18, 2024 notice gives 1-800-FDA-1088 and www.fda.gov/medwatch for reporting suspected adverse events, and says clinicians who see a new malignancy should also contact the manufacturer. [5]

Other pathways in the United States

The FDA notes that some products use different reporting pathways. Vaccines have an online reporting form, and tobacco products use the Safety Reporting Portal. [1] [2]

United Kingdom

The Yellow Card scheme, run by the Medicines and Healthcare products Regulatory Agency (MHRA), lets anyone report an issue with a medicine, vaccine, medical device (including software, apps and artificial intelligence), blood product or e-cigarette. [6] The site says it cannot provide medical advice and tells people worried about their health to speak to a doctor or pharmacist or call NHS 111. [6]

Other countries

Pages for other regulators, such as Health Canada and Australia's TGA, could not be read for this page, so we do not describe their processes. Check your own national medicines regulator.

What a report can and cannot do

• It can raise a signal. The FDA said post-treatment T cell malignancy was listed as a potential signal of serious risk identified from its adverse event reports. [5]
• It does not settle cause. Reports describe what happened after use. A single report is not proof the product caused it. This is a general limit; the official pages above describe reports as inputs to FDA review.
• It helps others. The FDA says it uses the data for safety surveillance. [1]

Related guides

Side effects, allergic reactions and reporting, peptide safety and adverse events and long-term unknowns in new interventions.