life-threatening adverse event

life-threatening adverse event

In the context of a clinical trail, any adverse drug response that the investigator believes places the patient or subject at immediate risk of death from the reaction as it occurred. This does not include a reaction that might have caused death had it occurred in a more severe form.
References in periodicals archive ?
Most treatment emergent adverse events were of mild (Grade 1) or moderate (Grade 2) severity, and no life-threatening adverse events were reported.
The FDA recently warned that unapproved use of Infuse had been linked to serious and life-threatening adverse events.
In December, the FDA issued a public health advisory about fentanyl patches, warning that the agency has continued to receive reports of fatalities and life-threatening adverse events related to fentanyl overdoses in cases where the fentanyl patch was used to treat pain in opioid-naive patients; and when opioid-tolerant patients have applied more patches than prescribed, changed the patch too frequently, or exposed the patch to a heat source, such as a heating pad (INTERNAL MEDICINE NEWS, Feb.
Many clinically significant, life-threatening adverse events were included among these 43 cases: 5 people who had a cardiac arrest or sudden death; 2 with myocardial infarctions; 3 with arrhythmias; 4 with strokes; 1 with seizures; and 8 people with palpitations, tachycardia, or both.
rheumatologists and MCO pharmacy directors indicate that better reduction in pain intensity and fewer serious and life-threatening adverse events are two of the greatest unmet needs in osteoarthritic pain.
However, as with all medications, NSAIDs are not without risks and can cause significant and even life-threatening adverse events that affect gastrointestinal (digestive system), renal (kidney) and cardiovascular (heart) health.
The action was taken "pending review of reported and serious life-threatening adverse events associated with use of the product," the FDA said.
Life-threatening adverse events are rare but possible and early recognition is critical.
As a result, new therapies can be prescribed that create a range of potentially life-threatening adverse events," he explained.
Sixty-one percent of the most serious and life-threatening adverse events are IV drug related.
STOCRIN should not be administered concurrently with astemizole, cisapride, triazolam, midazolam, or ergot derivatives because competition for CYP3A4 by efavirenz could result in inhibition of metabolism of these drugs and create the potential for serious and/or life-threatening adverse events (e.