Food and Drug Administration Adverse Events Reporting System

Shaffer D, Singer S, Korvick J, Honig P. Concomitant risk factors in reports of torsades de pointes associated with macrolide use review of the United States Food and Drug Administration Adverse Event Reporting System. Clin Infect Dis 2002 35(2) 197-200. 

Rudd GD, Haverkamp W, Mason JW et al (2015) Lacosamide cardiac safety clinical trials in patients with partial-onset seizures. Acta Neurol Scand 132 355-363 Salk A, Ehrenpreis ED (2016) Attitudes and usage of the Food and Drug Administration Adverse Event Reporting System among gastroenterology nurse practitioners and physician assistants. Gastroenterol Nurs 39 25-31... 

Gandhi PK, Gentry WM, Bottorff MB. Thrombotic events associated with Cl esterase inhibitor products in patients with hereditary angioedema investigation from the United States Food and Drug Administration adverse event reporting system database. Pharmacotherapy... 

SaUc A, Stobaugh DJ, Deepak P, Ehrenpreis ED. Ischaemic colitis with type I interferons used in the treatment of hepatitis C and multiple sclerosis an evaluation from the food and drug administration adverse event reporting system and review of the literature. Ann Pharmaco-ther 2013 47(4) 537.A2. 

The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS collects and analyzes information from reports of adverse reactions after immunization. Anyone can report to VAERS, and reports are sent in by vaccine manufacturers, health care providers, and vaccine recipients and their parents or guardians. An example of the VAERS and instructions for completing the form are found in Appendix F. Any clinically significant adverse event that occurs after the administration of any vaccine should be reported. Individuals are encouraged to provide the information on the form even if the individual is uncertain if the event was related to the... 

U.S. Food and Drug Administration, Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between January-March 2008, FDA. Available online. URL http //www.fda. gov/Oder/aers/potential signals/potential signals 2008Q1. htm. Updated Febru-ary 4, 2009. 

Wysowski DK, Green L. Serious adverse events in Norplant users reported to the Food and Drug Administration s MedWatch Spontaneous Reporting System. Obstet Gynecol 1995 85(4) 538-42. 

The Special Nutritionals Adverse Event Monitoring System (SN/AEMS) of the U.S. Food and Drug Administration (FDA), a database of consumer reactions to nutritional supplements and substances, has had 31 reports of adverse reactions to products containing creatine between 1993-1998. Reported symptoms include (but were not limited to) ... 

Food and Drug Administration. (1999, July 2). Adverse Event Reporting System (AERS) Freedom of Information (FOI) report. Rockville, MD Center for Drug Evaluation and Research. 

Industry-sponsored and advocacy-related adverse event reporting (AER) agencies address safety-related events to the FDA for dietary supplements (www.SafetyCall.com). These groups submit AERs to the Food and Drug Administration s Center for Food Safety and Applied Nutrition s Adverse Event Reporting System (CAERS) at (http //www.fda.gov/opacom/backgrounders/problem.html). 

By 1988 it was possible to summarize the adverse effects reported after the distribution of over 1.8 million doses of plasma-derived hepatitis B vaccine (Table 1) (2). From 1982 onwards, the Centers for Disease Control, the Food and Drug Administration, and the manufacturers, Merck Sharp Dohme, had supported a special surveillance system to monitor spontaneous reports of reactions to plasma-derived hepatitis vaccine. During the first 3 years, about 850 000 persons were immunized. In all, 41 reports were received for one of the following neurological adverse events convulsion (n = 5), Bell s palsy (n — 10), Guillain-Barre syndrome (n = 9), lumbar radiculopathy (n — 5), brachial plexus neuropathy (n = 3), optic neuritis (n — 5), and transverse myelitis (n = 4). Half of these events occurred after the first vaccine dose. However, no conclusive causal association could be made between any neurological adverse event and the vaccine (3). 

FDAMA Food and Drug Administration Modernization Act HMOs, health maintenance organizations VAERS, Vaccine Adverse Event Reporting System CERTs, Centers for Education and Research on Therapeutics ADR, adverse drug reaction... 

Food and Drug Administration (FDA) Surveillance System. This was developed and is managed by the FDA. As part of this system, all adverse events reports concerning medical products after their formal approval are submitted to the FDA. In the case of medical devices, the device manufacturers report information on items such as deaths, serious injuries, and malfunctions. Furthermore, the device user facilities such as hospitals and nursing homes are required to report deaths to both the FDA and manufacturers and also serious injuries to device manufacturers. In regard to drug-related adverse events, reporting is mandatory for all manufacturers, but it is voluntary for physicians, consumers, and so on [2]. 

Immunologic Anaphylaxis associated with omalizumab treatment is of growing concern. In the US Food and Drug Administration s Adverse Event Reporting System between January 2007 and June 2008 there... 

OSAS (Office of Scientific Analysis and Support). 2002. Letter to Stakeholders. Announcing CAERS—The CFSAN Adverse Event Reporting System. Online. Center for Food Safety and Applied Nutrition, Food and Drug Administration. Available at http //www.cfsan.fda.gov/ dms/caersltr.html. Accessed January 21, 2003. 

Body temperature In an analysis performed using the US Food and Drug Administration s Adverse Events Reporting System database, hypothermia was associated with concomitant administration of topiramate and valproic acid in patients who tolerated either drug alone (see also Topiramate ) [326 ]. 

Observational studies Anthrax vaccine adsorbed (AVA) is the only US licensed AVA vaccine approved by the Food and Drug Administration. In recent years, the safety of anthrax vaccine has been controversial, stimulating reviews of its safety and efficacy. During 1 March 1998 to 14 January 2007, about 6 milhon doses of AVA vaccine were administered. As of 16 January 2007, 4753 reports of adverse events after the use of AVA had been submitted to the Vaccine Adverse Event Reporting System (VAERS) [ll ]. The most commonly reported were myalgia, arthralgia, pain, headache, depression, asthenia , rash, anxiety and insomnia, and back pain. Reports to VAERS did not definitively link any serious unexpected risks to this vaccine, and a review of deaths... 

Cardiovascular A retrospective data mining analysis of the United States Food and Drug Administration (FDA) adverse event report system database identified 10 cases (2 male, mean age 37.4 years) of thrombotic events associated with administration of one Cl esterase inhibitor product (Cinryze ). The authors identified an elevated IC025 (the lower limit of the 95% two-sided Cl of the information component) of 2.91 suggesting a higher than expected likelihood of causation between product administration and thrombotic-related preferred terms used in the analysis [36 ]. 

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