If you have a complaint about a product regulated by the Food and Drug Administration (FDA), the agency wants to hear about it. Two of the main reporting systems available to consumers are the Consumer Complaint Reporting system and MedWatch.

Consumer Complaints
FDA's Consumer Complaint Coordinators (CCCs), located in FDA offices throughout the United States and Puerto Rico, will listen, document your complaint about an FDA-regulated product, and follow up as necessary. Consumers should report problems to the CCC for their geographic region. (Click here for a list of CCCs.)

Some examples of complaints that your CCC wants to hear about are:

• food-related illnesses, especially when a specific food is suspected 
• allergic reactions when a person has a known allergy to a food ingredient not identified on the product label 
• problems related to infant formula 
• problems related to baby food 
• swollen or leaking canned goods 
• suspected product tampering 
• adverse events after taking dietary supplements 
• problems related to prescription or over-the-counter medications 
• problems related to pet food and treats

"Just a few complaints can make a difference," says Joan Trankle, FDA's National CCC. For example:

• CCCs in different parts of the country received three reports of allergic reactions to a type of soymilk. FDA followed up with an inspection of the soymilk company. The product did not declare the allergenic substance, milk protein, on the label, and the company recalled the product. 
• CCCs received two complaints in one week about skin burns after use of an adhesive patch that generates heat to relieve muscle and joint pain. "When that second complaint arrived, we sprang into action," says Trankle. "We contacted the firm and, based on our follow-up, the firm recalled the product."

Complaints of a less serious nature, or those that appear to be isolated incidents, are monitored and the information is used during a future inspection of a company to help the FDA identify problem areas in a production plant. The complaints are also discussed with company management during these inspections.

MedWatch
MedWatch is for reporting any adverse events (unexpected side effects) that occur while using human health care products and some other FDA-regulated products such as:

• human drugs (both prescription and over-the-counter) 
• medical devices (for example, contact lenses, glucose tests, pacemakers, and medical X-rays) 
• blood products, human cell and tissue products, and other biologics (except vaccines, which are reported to another system) 
• special nutritional products (dietary supplements, infant formulas, and medical foods such as nutritional supplements used under medical supervision) 
• cosmetics

When the FDA approves a medical product, the agency has determined that the benefits of the product outweigh the risks. "But every product that FDA approves carries some risk," says Norman Marks, M.D., Medical Director of the FDA's MedWatch Program. "Sometimes there are risks that only come to light after a medical product gets on the market and is used in a larger number of patients, for a longer period of time, and in patients whose health characteristics are different from those of the patients studied before approval." So continued monitoring of adverse events is essential and depends on reporting of these events to FDA so they can be entered in MedWatch.

Every MedWatch report is recorded in an FDA database for review and comparison to similar previous reports. When added together, reports can signal a safety problem and lead to an FDA action to protect the public, says Marks. "Reporting can help you, a family member, or someone else avoid harm, serious illness, or even death."

Reporting to MedWatch is easy, confidential, and secure. The FDA encourages you to have your healthcare professional either complete the MedWatch form for you or help you complete the form yourself. "Health care professionals have test results and other clinical information that will help us better evaluate the report," says Marks.

Reporting by healthcare professionals is voluntary. If they choose not to report, or if you'd rather file the report yourself, you may use one of these methods:

• Online - Use the interactive form. FDA encourages online reporting because it is the quickest and most direct route. 
• Mail - Download the pre-addressed, postage-paid form (FDA Form 3500) here or call 1-800-FDA-1088 to request the form. 
• Fax - Get the form (as above) and fax to 1-800-FDA-0178. 
• Phone - Call 1-800-FDA-1088 MonFri 8a.m. - 4:30 p.m. EST.

If you or your health care professional do not want to complete a MedWatch report, you may report a problem with a health care product to your CCC. "There are times when consumers want to explain their problem and have us record the complaint," says Trankle. "This gives us the advantage of being able to ask questions and obtain important information that we might not get if they were filling out a MedWatch report."

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This article was originally published in FMOnline. This free online newsletter is only available to registered members. Click here to register!
 
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FM in the Classroom
Getting Through the Schoolday When You Have FM
Review: "Sit and Be Fit: Fibromyalgia Workout"
 

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