Iwona Stolarek joined the Commission as medical advisor in January 2015 and was appointed clinical lead for the adverse events
programme in July 2015.
According to CRN, "In order for the industry to effectively satisfy the obligation of reporting serious adverse events
received, all reports, including those for non-serious adverse events
, must be evaluated.
The Question: What adverse events
occur when children are treated with acupuncture?
SEATTLE - A scoring system based on comorbidities identifies patients at increased risk for warfarin's adverse events
, according to researchers from HealthCore Inc.
Indeed, recent studies suggest that adverse events
due to hospital care remain common (Rozich, Haraden, and Resar 2003; Resar et al.
A higher rate of adverse events
in older patients with knee osteoarthritis treated topically for 12 weeks with a nonsteroidal anti-inflammatory drug, compared with placebo, was caused mainly by application-site reactions but included one serious cardiovascular event that might have been related to the drug treatment, a post hoc analysis of data on 538 patients found.
Julia Neily from Veterans Health Administration, White River Junction, Vermont and colleagues analyzed 212 surgical adverse events
and 130 close calls from root cause analysis teams and incident reports in an effort to provide information and proposed solutions regarding incorrect surgical events.
Thus, the patients revealed twice the number of adverse events
as the medical records did.
In 1998 consumers reported 23,691 adverse events
to the FDA, compared with 48,314 reports from physicians.
Indeed, the April 2001 Department of Health and Human Services report Adverse Event
Reporting for Dietary Supplements: An Inadequate Safety Valve cites an unnamed FDA-commissioned report as finding that the FDA receives reports of less than 1% of all adverse events
associated with dietary supplements.
said that the FDA and EU are implementing new requirements for the reporting of adverse drug reactions, and there are also new requirements in store for reporting adverse events
with dietary supplements.