FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

Email this Page To a Friend

E-Mail, Snail Mail, Phone, or Fax

Reporting Adverse Reactions and Other Product Problems

by John Henkel

The Michigan consumer knew right away that something was wrong with the pretzel he had just eaten. His mouth was burning as if it had been exposed to a caustic chemical. After being treated at the hospital, he contacted the local Food and Drug Administration office, which found that the pretzel company had put lye cleaning pellets on the pretzels instead of salt. As a result, the company recalled all the snacks.

By contacting FDA like the Michigan consumer did when adverse reactions or other problems occur with products the agency regulates, consumers can play a crucial public health role. FDA is responsible for ensuring that foods are safe, wholesome, and correctly labeled. The agency also oversees medicines, medical devices (from bandages to artificial hearts), blood products, vaccines, cosmetics, veterinary drugs, animal feed, and electronic products that emit radiation (such as microwave ovens and video monitors), ensuring that these products are safe and effective.

The testing that helps to establish the safety of products such as drugs and medical devices is typically conducted on small groups before FDA approves the products for sale. Yet some problems can remain unknown, only to be discovered when a product is used by a large number of people.

When problems with FDA-regulated products occur, the agency wants to know about them and has several ways for the public to make reports. Timely reporting by consumers, health professionals, and FDA-regulated companies allows the agency to take prompt action. The agency evaluates each report to determine how serious the problem is, and, if necessary, may request additional information from the person who filed the report before taking action.

Reporting an Emergency

If the situation is an emergency that requires immediate action, such as a case of food-borne illness or a drug product that has been tampered with, call the agency's main emergency number, (301) 443-1240, which is staffed 24 hours a day,

You also can report emergencies to an FDA consumer complaint coordinator for the geographic area in which you live.

Non-Emergency Reports

If you experience a problem that does not require immediate action--such as a non-emergency adverse reaction to a food product or an over-the-counter medical device that doesn't work as advertised--you can report it to the appropriate consumer complaint coordinator.

MedWatch

FDA's MedWatch program is designed to monitor adverse events and other problems with medical products to ensure that new safety information is quickly communicated to medical professionals. Products covered under the MedWatch program are medicines (prescription and over-the-counter), medical devices, blood products, and special nutritional products (dietary supplements, infant formula, and medical foods). The program aims to enhance postmarketing surveillance of medical products as they are used in clinical practice and to rapidly identify serious reactions and hazards associated with those products.

If you or a family member has experienced or witnessed a serious adverse reaction or other problem with a medical product, call MedWatch at 1-800-FDA-1088 (1-800-332-1088) to request that a reporting form (one-page, return postage paid) be mailed to you. A reaction is considered serious if the product caused, or is suspected of having caused: death, a life-threatening situation, admission to a hospital or a longer-than-expected hospital stay, permanent disability, a birth defect, or medical care to prevent permanent damage.

Forms and instructions also can be downloaded from www.fda.gov/medwatch/ on the agency's Web site.

FDA encourages consumers to take the form to their health professional (doctor, dentist, pharmacist, or nurse) to complete. This person can provide much more detailed clinical information, such as laboratory results, which can help FDA evaluate the report. However, if they prefer not to go to a health professional, consumers can complete the form themselves and mail it to the FDA address on the form or fax it to 1-800-FDA-0178 (1-800-332-0178).

Because reporting by health professionals is voluntary, consumers are encouraged to file a report on their own if the health professional chooses not to report the problem.

FDA also welcomes reports through MedWatch of product quality problems. For example, you can report product contamination (suspicious foul odors or unusual "off" colors), defective components, labeling concerns (such as mix-ups due to similar names or packaging), or questionable product stability.

Other Products

• Vaccines--Adverse reactions and other problems related to vaccines should be reported to the Vaccine Adverse Event Reporting System, which FDA and the Centers for Disease Control and Prevention maintain jointly. For a copy of the vaccine reporting form, call 1-800-822-7967.
• Foods--To report problems, including adverse reactions, related to any food except meat and poultry, call the FDA consumer complaint coordinator for your area (see accompanying article). If the problem involves meat or poultry, which are regulated by the U.S. Department of Agriculture, call the USDA hot line at 1-800-535-4555.
• Veterinary Products--Report any problems with veterinary drugs and animal feed to FDA's Center for Veterinary Medicine at 1-888-FDA-VETS (1-888-332-8387).
• Cosmetics--Call the FDA Cosmetics and Colors Automated Information Line at 1-800-270-8869 for information on how to report adverse reactions to cosmetics, as well as problems such as filth, decomposition or spoilage.
• Medical Advertising--To report fraudulent or misleading advertising or promotion of FDA-regulated products, call 301-827-2828.

John Henkel is a staff writer for FDA Consumer.

General Guidelines About Reporting

• Report what happened as soon as possible. Give names, addresses and phone numbers of persons affected. Include your name, address and phone number, as well as that of the doctor or hospital if emergency treatment was provided.
• State the problem clearly. Describe the product as completely as possible, including any codes or identifying marks on the label or container. Give the name and address of the store where the product was bought and the date of purchase.
• You also should report the problem to the manufacturer or distributor shown on the label and to the store where you bought the product.

What FDA Doesn't Handle

Reports and complaints about the following should be made to the agencies listed. Phone numbers can be found in your local phone directory:

• Restaurant food and sanitation--Local or state health departments
• Unsolicited products in the mail--U.S. Postal Service
• Accidental poisonings--Poison control centers or hospitals
• Pesticides or air and water pollution--U.S. Environmental Protection Agency
• Hazardous household products (including toys, appliances, and chemicals)--Consumer Product Safety Commission, 1-800-638-2772
• Alcoholic beverages--Department of the Treasury's Bureau of Alcohol, Tobacco and Firearms
• Drug abuse and controlled substances--Department of Justice's Drug Enforcement Administration
• Hazardous chemicals in the workplace--Department of Labor's Occupational Safety and Health Administration
• Warranties--Federal Trade Commission
• Dispensing and sales practices of pharmacies--State board of pharmacy
• Medical practice--State board of healing arts
• General Information: If you have a general question about an FDA-regulated product, call 1-800-532-4440. Or take a look at the Frequently Asked Questions section (www.fda.gov/opacom/faqs/faqs.html) on FDA's Website. But please don't report problem products or adverse reactions to this consumer information number or through the Website. Use the other numbers listed elsewhere in this article.

--J.H.

FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility

FDA Office of Public Affairs
FDA Consumer Magazine