12 million adverse reaction reports from Food and Drug Administration's Adverse Event Reporting System
(FAERS) were analyzed to conclude that tramadol consumption was significantly linked to hypoglycemia.
Food and Drug Administration in College Park, Maryland, and colleagues used data from the FDA Center for Food Safety and Applied Nutrition Adverse Event Reporting System
(2006 through 2015) to understand dietary supplement-associated adverse events caused by pill size.
ENPNewswire-August 9, 2019--Sarepta Therapeutics Comments on Erroneous Submission to US FDA Adverse Event Reporting System
Shares of Sarepta Therapeutics dropped over 12% before being halted following news of a FDA Adverse Event Reporting System
report that a patient was hospitalized with rhabdomyolysis after being administered their Duchenne muscular dystrophy gene therapy, Piper Jaffray analyst Danielle Brill tells investors in a research note.
In a study published in JAMA Dermatology, the researchers reviewed data from the FDAs Adverse Event Reporting System
(AERS) between 1997 and 2017.
The study, published in the Journal of Adolescent Health, looked at adverse event reports between January 2004 and April 2015 in the FDA Adverse Event Reporting System
on the food and dietary supplements database.
During July 11, 2018-March 29, 2019 in the United States, the Vaccine Adverse Event Reporting System
(VAERS) received 125 reports of 192 patients receiving expired IIV during the 2018-19 influenza season (2), during which time 169.1 million doses of seasonal influenza vaccine were distributed (3).
The Food and Drug Administration (FDA) Adverse Event Reporting System
(FAERS) is integrated into Evidex.
Since the FDA approved alemtuzumab in 2014 for relapsing forms of MS, 13 cases of ischemic and hemorrhagic stroke or arterial dissection have been reported worldwide via the FDA Adverse Event Reporting System
, but "additional cases we are unaware of may have occurred," the FDA said in the announcement.
The Study: In this retrospective study, researchers looked at data since January, 2014 from the Vaccine Adverse Event Reporting System
for cases of babies under nine months of age receiving either the MMR or the MMRV vaccination.
Data also are limited regarding RIVs, the CDC said, with the data used to determine safety among pregnant women "limited to reports of pregnancies occurring incidentally during clinical trials, Vaccine Adverse Event Reporting System
(VAERS) reports, and pregnancy registry reports."
For the study, Xu and his colleagues examined adverse events data in the FDA's Center for Food Safety and Applied Nutrition's Adverse Event Reporting System
(CFSAN), a repository made publicly available in 2016.