FDA Encourages Consumers to Report Adverse Reactions Associated with Drugs, Medical Devices and Dietary Supplements

The United States Food & Drug Administration is responsible for the safety and effectiveness of health related products. FDA approves drugs and medical devices based on pre-marketing tests submitted by manufacturers. However, FDA does not do its own testing, and the studies done by companies seeking product approval are often flawed or are too small in size to accurately predict the full range of adverse reactions that may occur once a drug and device is offered to the public at large. Moreover, FDA has only limited authority over so-called “dietary supplements” such as “natural” weight loss and sexual enhancement products, and the safety of such products are not realized until marketing to consumers is well underway.

When 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 FDA’s post-marketing surveillance 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.”

Because FDA, doctors, and consumers may be unaware of the full nature and extent of adverse reactions that may be associated with drugs, devices and dietary supplements, it is critical that when such reactions occur they are reported to the agency. Many doctors and hospitals do report suspected adverse reactions occurring among their patients, but studies show that the vast majorities of reactions may not be reported, meaning that FDA action in the form of labeling changes or even product recalls may be delayed with disastrous results for consumers.

FDA offers several different ways in which consumers may report suspected adverse events. FDA’s Consumer Complaint Coordinators (CCC’s) 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. (See the list of CCC’s on FDA’s Webpage).

In addition to contacting CCC’s, consumers can report problems using FDA’sMedWatch reporting system, which is the same system used by doctors and hospitals. 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), and cosmetics.

According to the FDA, “reporting to MedWatch is easy, confidential, and secure.” Information about adverse experiences is reported on a MedWatch form. FDA encourages consumers to have their doctors either complete the form or consumers may complete the form themselves. “Health care professionals have test results and other clinical information that will help us better evaluate the report,” says Marks.

Reporting by health care professionals is voluntary. If they choose not to report, or if consumers would rather file reports themselves, they may use one of the following methods:

  • Online – Use the interactive form at FDA Form 3500. FDA encourages online reporting because it is the quickest and most direct route.
  • Mail – Download the pre-addressed, postage-paid form (FDA Form 3500) 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 Mon–Fri between 8:00 a.m. and 4:30 p.m. EST.

If you or your health care professional does 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.”

FDA advises that CCC’s and MedWatch are for reporting problems; neither provides medical advice. If consumers experience an adverse event, they should contact their health care professional first and then report the problem to FDA.

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The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience litigating and resolving lawsuits and claims all over the United States involving injuries caused by exposure to a variety of drugs, medical devices, and dietary supplements. If you or someone close to you has suffered injuries that may be related to drugs, medical devices, or dietary supplements, we are here to help ensure that your rights are fully protected.

If you or someone close to you has been diagnosed with an illness linked to a drug, medical device, or dietary supplement, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.