The U.S. Food and Drug Administration (FDA) has enhanced its MedWatch program and is actively asking consumers to report adverse events and serious safety issues with regard to FDA regulated products, whether they be medications, medical devices, or food products. The FDA encourages strongly consumers to use the MedWatch platform, first created in 1993, to report experiences with problematic products that seem to have unexpected side effects, injurious medical errors, therapeutic failures, issues with product quality, and any other safety hazards.
According to the FDA, consumers “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.”
Consumers are not expected to have proof of the product problem when filling out the FDA MedWatch Consumer Voluntary Reporting form. They may report on a FDA product issue either by submitting a form online, downloading the form and sending it by regular mail or fax, requesting a form by calling the toll-free number 1-800-332-1088, or asking their healthcare professional to file a MedWatch report for them.
“MedWatch advances the public health by helping make medicines safer and helping you get the safety information you need to about human medical products,” said Beth Fritsch, RPh, MBA, deputy director of FDA’s Office of Health and Constituent Affairs. “Every report counts.”
The kinds of products that should be reported to MedWatch include: 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; and food, including beverages and ingredients added to foods.
“If it’s serious to you, we need to know,” stated Anna Fine, PharmD., M.S., director of FDA’s Health Professional Liaison Program.
Obtaining Justice For The Injured
Lieff Cabraser has played a leading role in many of the largest, most important personal injury law and wrongful death lawsuits in the U.S. These cases have involved negligent conduct as well as a vast range of defective products — from dangerous prescription drugs and faulty medical devices to unsafe vehicles and consumer products. In many cases, we assisted our clients in persuading the corporate defendants to issue recalls or improve their safety procedures for the protection of all consumers and patients.
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If you or a family member have been injured by a product or conduct you suspect relates to fraudulent or negligent conduct by another, please feel free to use the form on the case page to contact an experienced personal injury attorney at Lieff Cabraser, or call us toll-free at 1 800-541-7358.