FAERSFDA (Food and Drug Administration) Adverse Event Reporting System (database)
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Our investigation to date indicates that this report was not submitted to the FAERs database by a Sarepta employee or the study's principal investigator.
proprietary clinical trials safety outcomes database, when linked with optimized post-approval spontaneous reporting data from the FDA Adverse Event Reporting System (FAERS) and Vigibase, claims data and social media provides pharmacovigilance professionals with software, data and analytics to track emerging safety issues through multiple data sets, validate signals seen in spontaneous reporting and engage across these various data sets in dynamic and proactive manner.
The FAERS database includes reports regardless of whether AEs are attributable to the drug (versus an underlying condition, for example).
They examined rates of SJS and TEN for several AEDs using adverse event data from FAERS between July 2014 and December 2017.
In FAERS reports that included a cause of death (many reports did not provide sufficient information to assess drug cause and effect), there was no evident pattern to suggest a drug effect.
The FDA reviewed 51 cases of chemical leukoderma associated with the Daytrana patch (methylphenidate transdermal system) reported to the FDA Adverse Event Reporting System (FAERS) database and described in the medical literature from April 2006 to December 2014.
For additional information about AERS, see Adverse Event Reporting System (FAERS) (formerly AERS), U.S.
The Food and Drug Adverse Event Reporting System (FAERS) collects ADR from the US as well as rare and severe events from other countries.
Before requiring new warnings, the FDA reviewed its Adverse Event Reporting System (FAERS, formerly known as AERS) database.
[17] FDA Adverse Event Reporting System (FAERS), http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm.