Serious adverse events requirements

Certain adverse events, e.g those leading to discontinuation, death, and other serious adverse events, require narrative summaries to be written and submitted. These narratives should not simply repeat in sentence format the information that was presented in the body of the clinical study report in numerical format. Rather, the narratives should permit an adequate understanding of the nature of each adverse event by providing a complete synthesis of all available clinical data and an informed discussion of the case (FDA 2005, p. 26). Useful components in a narrative include ... 

If your report Involves a serious adverse event With a device and It occurred in a facility outside a doctor s office, that facility may be legally required to report to FDA and/or the manufacturer. Please notify the person in that facility who would handle such reporting. 

A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. 

An adverse event form should be provided by the sponsor, which will have clear instructions as to what constitutes minor, major and serious adverse events, how these are to be recorded, and what action is required as a consequence. 

The investigator shall report all serious adverse events immediately to the sponsor except for those that the protocol or investigator s brochure identifies as not requiring immediate reporting. The immediate report shall be followed by detailed, written reports. The immediate and follow-up reports shall identify subjects by unique code numbers assigned to the latter. 

Ketorolac tromethamine Ketorolac is indicated for the short-term (up to 5 days) management of moderately severe acute pain that requires analgesia at the opioid level. It is not indicated for minor or chronic painful conditions. Increasing the dose beyond the label recommendations will not provide better efficacy but will result in increasing risk of developing serious adverse events. 

Aerosol - Several serious adverse events occurred in severely ill infants with life-threatening underlying diseases, many of whom required assisted ventilation. Additional reports of worsening of respiratory status, bronchospasm, pulmonary edema, hypoventilation, cyanosis, dyspnea, bacterial pneumonia, pneumothorax, apnea, atelectasis, and ventilator dependence have occurred. Sudden deterioration of respiratory function has been associated with initiation of aerosolized ribavirin use in infants. If ribavirin aerosol treatment produces sudden deterioration of respiratory function, stop treatment and reinstitute only with extreme caution, continuous monitoring, and consideration of coadministration of bronchodilators. 

Because of the problems that resulted from self-regulation, another law, the Dietary Supplement and Non-Prescription Drug Consumer Protection Act, was approved in 2006. This law requires manufacturers, packers, or distributors of supplements to submit reports of serious adverse events to the FDA. Serious adverse events are defined as death, a life-threatening event, hospitalization, a persistent or significant disability or incapacity, congenital anomaly or birth defect, or an adverse event that requires medical or surgical intervention to prevent such outcomes based on reasonable medical judgment. If this requirement were enforced, and consumers cooperated, these reports would make it possible to identify trends in adverse effects and would help to alert the public to safety issues. 

Adverse events/concomitant medications are recorded according to protocol. Serious adverse events have been appropriately reported within the period required by the protocol, GCP, the sponsor, and the FDA. 

The pharmacokinetics and safety of the 5% lidocaine patches have been studied in 20 healthy volunteers, who applied four patches to the skin either every 24 hours or every 12 hours for 3 days (67). Mean steady-state plasma concentrations were 186 and 225 ng/ml respectively, well below those required for an antidysrhythmic effect (1500 ng/ml) or a risk of toxicity (5000 ng/ml). The patches were well tolerated, with no major cutaneous adverse effects. This is in line with data from postmarketing surveillance studies, which have shown that since the availability of lidocaine patches in 1999, no adverse cardiac or other serious adverse events have been reported (68). 

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