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.
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The Code of Federal Regulations* defines a serious adverse event associated with using a biologic product in humans as any of the following: death, life-threatening adverse event, inpatient hospitalization or prolongation of an existing hospitalization, persistent or substantial disability/incapacity, congenital anomaly/birth defect, or an important medical event that requires medical or surgical intervention to avert one of these outcomes.
The study will also consider other measures of functional recovery, biomarker data and clinical outcomes, including hospitalization, mortality and life-threatening adverse events, and post-stroke complications such as infection.
In general, DSCs communicate issues affecting a large number of patients, potentially serious or life-threatening adverse events, new contraindications or warnings, a previously uncharacterized drug-drug or drug-disease interaction, or a medication error that could result in a serious or life-threatening adverse reaction.
She explains that consumers may not know exactly what they are getting when buying such antiviral products on the Internet from an unfamiliar company, adding that patients who buy prescription drugs from web sites operating unlawfully are at increased risk of suffering life-threatening adverse events.
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, and exposed the patch to a heat source, such as a heating pad.
No potentially life-threatening adverse events of a type known previously to be caused by smallpox vaccination have been reported as of March 10.
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.
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.
difficulty breathing; throat tightness and difficulty swallowing; swelling of lips, tongue, or face; and rash, hives, and itchy skin) are being followed up closely by contacting patients and clinicians to confirm or exclude possible hospitalizations and life-threatening adverse events.