On this page:
- What Types of Products Should I Report On?
- What Types of Problems Should be Reported?
- How Can I Submit a Report?
- How Your Report Will Help
Had an issue with a medicine, medical device, or food product and did not know who to notify? The Food and Drug Administration has a consumer-friendly form for reporting adverse events and other serious safety problems with FDA regulated products. The program that processes this information, and uses it to protect your health, is called MedWatch. And it needs your help.
By reporting to MedWatch your experience with, or suspicion of, a product problem, you could help identify an unknown risk and potentially trigger a variety of preventive and protecting actions—from changes to a warning label to sending out a safety message and to removal of the product from the market.
- Prescription and over-the-counter medications
- Nutrition products, including infant formulas, dietary supplements, and herbal remedies
- Cosmetics or make-up products
- Medical devices, from contact lenses and breast implants to blood glucose meters and pacemakers
- Biologics, such as human cells and tissues for transplantation
- Food, including beverages and ingredients added to foods
Consumers should report unexpected side effects, product quality problems, mistakes when using a product and other safety issues to MedWatch.
“If it’s serious to you, we need to know,” notes Anna Fine, PharmD., M.S., director of FDA’s Health Professional Liaison Program. She also points out that consumers are not expected to provide proof that the problem was caused by a particular product. Here are some examples of reportable issues:
Unexpected side effect – Acetaminophen is a non-prescription drug commonly used for pain or fever. Recently, MedWatch reports enabled FDA to learn and to notify consumers, health care professionals and patients that acetaminophen was associated with rare but serious skin reactions.
Medication error – It can be caused by various factors, including confusion between two products with similar brand or generic names and packaging; illegible handwriting on prescriptions; as well as similar product characteristics, such as the drug strength and how often the medicine should be used.
Therapeutic failures – If you notice that the product does not seem to work as well when you switch from one generic or brand product manufacturer to another, the MedWatch team wants to know about it.
Product quality problem – Ever noticed a device wasn’t working properly? For example, your blood glucose meter did not provide an accurate reading? Report it to MedWatch.
You can report problems to FDA's MedWatch Adverse Event Reporting Program several ways:
- Submit a paperless report online
- Download and send in a pre-addressed form by regular mail or fax to 1-800-FDA-0178
- Request a MedWatch form by calling our toll-free line, 1-800-332-1088, between 8 a.m. and 4:30 p.m. ET Monday – Friday
Consumers can also ask their doctor, pharmacist or other health care professional to file a MedWatch report on their behalf. You can submit a report to the FDA or the product manufacturer. By law, companies are required to report to FDA certain serious problems that may have been caused by their products.
Additionally, you can use MedWatchLearn, a web-based learning tool, to practice submitting a voluntary report to the MedWatch program. This learning tool will teach you how to provide the key information the FDA needs to make a safety decision.
Consumer reports help FDA to identify side effects that may not appear in the product label. Over the past two decades, many important safety issues have been identified by consumers. Consumers may provide the first clue that an issue needs investigation. Even one voluntary report can enable FDA to determine if a safety action is needed.
“Most medical product studies involve a relatively small number of patients, and problems might not be detected until the products have been used by a large number of people,” says Norman Marks, M.D., M.H.A., medical advisor in the Office of Health and Constituent Affairs. Moreover, Marks adds, “Studies are generally not conducted over a long enough time to identify all of a product’s delayed side effects.”
It’s usually only after the product is on the market for some time that consumer reports alert FDA to a safety problem. For example, this was the case with finding that men using a testosterone gel on their upper arms and shoulders were inadvertently exposing, and harming, children. The MedWatch reports led to stronger product warning labels, urging that the gel be covered after application to prevent its exposure to children.
"MedWatch advances the public health by helping make medicines safer and helping you get the safety information you need to about human medical products,” says Beth Fritsch, RPh, MBA, deputy director of FDA’s Office of Health and Constituent Affairs. “Every report counts,”
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Updated: August 26, 2014