Serious adverse events spontaneous

Wysowski DK, Green L. Serious adverse events in Norplant users reported to the Food and Drug Administration s MedWatch Spontaneous Reporting System. Obstet Gynecol 1995 85(4) 538-42. 

The safety of gadobenate dimeglumine has been evaluated in 2367 adults aged 18-88 years and 173 children. The overall incidence of adverse events was 20%. Events related to the contrast agent were reported in 15 % of the adults. Most of the adverse events were mild and transient and resolved spontaneously. Headache, injection site reactions, nausea, taste disturbance, and vasodilatation were the most common, with frequencies of 1.0-2.6%. Serious adverse events potentially related to the contrast agent were reported in 0.2%. These events included laryngospasm, which developed 10 minutes after the contrast injection in a 51-year-old woman, severe vomiting in a 5-year-old child, and pulmonary edema in a 65-year-old patient. 

In Phase I and II studies, T)tpe A reactions are by far the most frequent. T)tpe B are rare, which is fortunate as some can be serious or even fatal. Table 7.1 shows the number of subjects that need to be studied to give a good chance (95%) of detecting an adverse event when there is no background incidence. The problem is many orders of magnitude worse if the adverse reaction closely resembles spontaneous disease that has a background incidence in the trial population. 

In a retrospective analysis of spontaneous adverse event reports encompassing more than 430, 000 patients who had received zoledronic acid between August 2001 and March 2003, only 72 cases of renal failure were identified by the US Food and Drug Administrahon [78, 79]. It should be noted, however, that patients with risk factors for renal deterioration, including advanced cancer, previous bisphosphonate exposure, and use of nonsteroidal anti-inflammatory medications, may have contributed to the progression of renal failure [79]. Because of the potentially serious nature of this adverse event, it is recommended to monitor renal funchon in patients with cancer before each infusion of zoledronic acid, provide adequate hydration, and modify or discontinue treatment if renal complications occur [30, 78, 79]. 

Spontaneous case reports can reassure a company if a report describes a large accidental overdose with no serious adverse effects. They can also provide reassurance, when reviewed as a whole set, that no reports for drug x causing event y have been received. Clusters of similar spontaneous reports should be meaningfully analyzed for consistency in time to onset, pattern of presentation and dechallenge, to identify a signal and to get a feel for its significance. 

Pharmacovigilance in complementary and alternative medicine Pharmacovigilance in complementary and alternative medicine has attracted much attention worldwide. The awareness of the need for surveillance of adverse reactions to natural health products has stimulated the implementation of a reporting system for suspected adverse reaction in Italy From April 2002 to March 2007, 233 spontaneous reports of suspected adverse reactions to natural health products were collected. A large proportion of the suspected adverse reactions were serious hospitalization was reported in 35% of cases 6% reported life-threatening clinical events, and there were two fatal events. Most of the reported cases involved herbal products (66%) 21 reports were associated with 27 homeopathic preparations, most of which contained a mixture of substances 14 reports attributed the suspected reactions to products containing propolis. 

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