FDA Asks Consumers to Report Problems

Food and Drug Administration Solicits Help from Consumers

The U.S. Food and Drug Administration, the federal watchdog for issues related to medicine, medical devices, pharmaceutical products and food, is asking consumers to be proactive in reporting concerns they have with these various products. The FDA’s Medwatch program offers a simple form that allows individuals to disclose any problems or negative experiences, so that the FDA can take appropriate measures, from changing the warning label on a product to recall it from distribution to the public.

The Types of Products Covered

The FDA has oversight over a broad spectrum of products, including:

• Food and beverages, and any ingredients added to them
• Over-the-counter and prescription drugs
• Nutritional products, from vitamins and other dietary supplements to herbal remedies and infant formulas
• Medical devices, such as implants, stents, pacemakers and joint replacements
• Human cells and tissue used in transplant surgery

The Types of Problems that Should Be Reported

The FDA wants to know about any defect or failure of a product to perform as advertised or promised. This includes:

• Any unanticipated side effects, such as fever, swelling, rash, pain, increased heart rate, nausea, dizziness or disorientation
• Product failure—the failure of a medical device to perform as stated, or inconsistency in performance
• Differences between brands—If one brand of medication or supplements works much better or much worse, the FDA wants to know
• Potential consumer confusion between two products that perform different functions, such as over-the-counter pharmaceutical products that have similar packaging.

You can submit a report online, download and mail a hard copy of a Medwatch report, or call the FDA toll free at 1-800-332-1088 to request a form.

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