Adverse Event Reporting System


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Adverse Event Reporting System

An interactive database designed to support the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biologic products.
References in periodicals archive ?
We have supported this critical effort since 1999 and look forward to leveraging our in-depth public health knowledge and technical expertise to further enhance the vaccine adverse event reporting system and its operation, as well as aid the government in responding to the challenges created by newly licensed vaccines, evolving vaccination schedules, and emergency immunization campaigns.
While reports of EPS symptoms associated with fetal exposure to older antipsychotics date back several decades, with periodic case reports describing EPS with increased muscle tone and tremor, data regarding the risk for these symptoms associated with the atypicals have been sparse and typically limited to small case series or adverse event reporting systems.
The Sentinel Initiative is designed to bring safety concerns from approved drugs and other medical products to FDA's attention faster than the traditional Med-Watch adverse event reporting system alone.
This means that no state or local government will be able to enact any law relating to a mandatory adverse event reporting system for nonprescription drugs or dietary supplements, if it is different from, or in addition to, this federal requirement.
CSS Informatics is integrating DrugLogic's Qscan([R]) technology, which provides safety surveillance and signal detection capabilities, with its Oracle([R]) Adverse Event Reporting System (AERS) services for clients to analyze patterns in adverse events that may indicate emerging pre- and post-market drug safety risks.
About 30,000 cases of adverse reactions to vaccines have been reported annually to the Vaccine Adverse Event Reporting System (VAERS) since 1990, with 10-15% classified as serious, meaning associated with permanent disability, hospitalization, life-threatening illness, or death.
The VSD conducts planned immunization safety studies following the introduction of new vaccines or changes in the immunization schedule, as well as timely investigations of hypotheses that arise from review of medical literature, clinical case reports, or reports from the Vaccine Adverse Event Reporting System (VAERS), a national passive adverse-event reporting system.
These were among the symptoms that have been reported to the FDA's Adverse Event Reporting System (AERS) in newborns born to mothers who had taken antipsychotics - which cross the placenta - during pregnancy.
Between 1976, when terbutaline was first marketed, and 2009, 16 maternal deaths associated with the obstetric use of terbutaline were reported to the FDA's Adverse Event Reporting System (AERS).
As the MET IDRs were not intended to support an adverse event reporting system, consumer complaints were collected in most cases during a single telephone contact at a customer service center.
This tool delivers intuitive analyses of the company's safety data, plus a comparison to related safety information in the FDA's Adverse Event Reporting System (AERS), a computerized information database designed to support the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biologic products.

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