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Spontaneous Adverse Event Case Reports

Information in the PI is typically based on the studies submitted by a drug s manufacturer. The FDA has also utilized spontaneous adverse event case reports as a tool in the evaluation of drug-grapefruit juice interaction labeling. Other sources of data that contribute to labeled information include studies or case reports from the medical literature. [Pg.293]

To identify case reports containing information on drug and grapefruit juice interaction, the Adverse Event Reporting System (AERS) (2) database [Pg.293]

The patient was documented to be stable on the drug product prior to receiving grapefruit juice, and, [Pg.294]

The patient was documented to be consuming grapefruit juice each day prior to starting drug therapy, or started grapefruit juice and the drug product at the same time, and, [Pg.294]

The adverse event (as described in 2 above) occurred upon initiation of drug therapy, and, [Pg.294]


Published case reports on alprazolam show a slightly different profile (266, 267, 268 and 269). Four patients had taken the drug for 4.5 months or less one had also taken chlorpromazine and trazodone and a fifth patient had taken alprazolam (3 mg/day for 26 weeks) and phenelzine (45 mg/day for 13 weeks), abruptly stopping both. According to the FDA s Spontaneous Adverse Event Reporting System, more seizures have been reported with alprazolam than with all other BZDs combined (270). The next highest incidence was reported for lorazepam. The FDA report stated the following ... [Pg.247]

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]. [Pg.556]

A series of 11 spontaneously reported cases in which renal impairment was associated with the use of nimesulide has been described (17). The adverse events were represented by acute renal insufficiency n — 2), acute deterioration of chronic renal insufficiency n — 3), fluid retention n = 4), and oliguria and macro hematuria n = 1 each). The patients had a median age of 57 (range 17-81) years and six had some predisposing condition (chronic renal insufficiency, heart failure, diabetes, use of diuretics) to NSAID-induced functional renal impairment. Apart from one patient, nimesulide was taken for a very short time (less than 8 days). A favorable outcome ensued after withdrawal of therapy in aU patients. The acute deterioration of renal function described in these patients pointed to hemodynamically mediated renal impairment in all cases, with the exception of one man in whom interstitial nephritis was suspected. [Pg.2525]

The database of the Swiss Drug Monitoring Center included 20 spontaneous reports (1987 to July 1992) of adverse events after the administration of tick-borne meningoencephalitis vaccine, among them 11 reports of cases with neurological symptoms (for example menin-gism, polyradiculitis, ataxia, vestibulopathy, facialis paresis). Most recovered completely within a few days. The incompleteness of the data did not allow conclusions regarding the causality of immunization (3). [Pg.3424]

The causality or treatment relatedness of clinical investigation cases is determined by the reporting healthcare professional or the sponsor, and is based on a reasonable suspected causal relationship between patient exposure to the suspect drug and the occurrence of the adverse event. Spontaneous reports about marketed products are always taken to imply that the reporter has assessed an adverse event with causality by the reported product (and are thus also always adverse events per se). [Pg.539]

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. [Pg.383]

The spontaneous case report database cannot be used to give an accurate incidence rate of even the Type B adverse reactions, as not all cases are reported, either because someone who should act as the reporter is not sufficiently motivated, or he/ she does not recognize the event as an adverse reaction in that patient (Kessler 1993 Fletcher... [Pg.383]

Over the six years from 1989 to 1995, 13 adverse events in patients receiving oral Echinacin were reported to the EGA in Germany, on the basis of spontaneous reporting by general practitioners. Of these, in only four cases were the adverse events considered to be causally related to the treatment. All four were cases of allergic skin reactions. [Pg.130]

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. [Pg.989]


See other pages where Spontaneous Adverse Event Case Reports is mentioned: [Pg.293]    [Pg.293]    [Pg.841]    [Pg.192]    [Pg.248]    [Pg.152]    [Pg.142]    [Pg.799]    [Pg.439]    [Pg.152]    [Pg.24]    [Pg.922]    [Pg.3082]    [Pg.3553]    [Pg.12]    [Pg.540]    [Pg.563]    [Pg.83]    [Pg.395]    [Pg.382]    [Pg.383]    [Pg.78]    [Pg.151]    [Pg.152]    [Pg.675]    [Pg.714]    [Pg.545]    [Pg.6]   


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