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The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products.
MedWatch was founded in 1993 to collect data regarding adverse events in healthcare. An adverse event is any undesirable experience associated with the use of a medical product. The MedWatch system collects reports of adverse reactions and quality problems of drugs and medical devices but also for other FDA-regulated products (such as dietary ...
The Vaccine Adverse Event Reporting System (VAERS) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). [1]
By 2019, the FDA tallied 82 suicides linked to Singulair and its generic versions reported to its adverse-event database since 1998. At least 31 of those reports involved someone age 19 or younger.
The FDA provides a database for reporting of adverse medical device events called the Manufacturer and User Facility Device Experience Database (MAUDE)[1]. The data consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996, and is open for public view.
The clinical hold was initiated following the Company's submission of a serious adverse event (SAE) and temporary enrollment halt to the FDA and other regulatory agencies. To date, three patients ...
Psychiatric adverse drug reactions, amnesia. [3] [66] Triparanol: 1962 France, US Cataracts, alopecia, ichthyosis. [3] Troglitazone (Rezulin) 2000 US, Germany Hepatotoxicity [2] Trovafloxacin (Trovan) 1999–2001 European Union, US Withdrawn because of risk of liver failure [2] [3] Valdecoxib (Bextra) 2004 US Risk of heart attack and stroke. [2 ...
Studies have shown that a GLP-1 drug, exenatide, sufficiently crosses the blood-brain barrier in rodent models of Parkinson’s disease, leading to improvements in motor performance, behavior ...