Adverse drug reactions spontaneous

In multiple countries, health-care professionals are encouraged to report adverse drug reactions spontaneously to the drug s sponsor, the appropriate governmental health agency, or a third party. In some countries, including the USA, Canada, and... 

Rawhns MD. Spontaneous reporting of adverse drug reactions I the data. Br J Clin Pharmacol 1988 26 1-5. 

Sachs RM, Bortnichak EA. An evaluation of spontaneous adverse drug reactions monitoring systems. Am ] Med 1986 81 49-55. 

Fletcher AP. Spontaneous adverse drug reaction reporting vs eventmonitoring a comparison./Roy Soc Med 1991 84 341-4. 

Griffin JP Survey of the spontaneous adverse drug reactions reporting schemes in 15 countries. Br / Clin Pharmacol 1986 22 Suppl 1 83S-100S. 

Harambnru F, Begaud B, Moride Y. Temporal trends in spontaneous reporting of unlabelled adverse drug reactions. Br J Clin Pharmacol 1997 44(3) 299-301. 

Schroeder DR. Statistics detecting a rare adverse drug reaction using spontaneous reports. Reg Anesth Pain Med 1998 23(suppl 2) I 83-1 89. 

As emphasized in chapter 13, the data once again confirm the importance of the spontaneous reporting system compared to controlled clinical trials in revealing dangerous adverse drug reactions, in this case violence and aggression. 

AC Rossi. Discovery of adverse drug reactions. A comparison of selected phase IV studies with spontaneous reporting methods. JAMA 249 26-28, 1983. 

Leone R, Venegoni M, Motola D, Moretti U, Piazzetta V, Cocci A, Resi D, Mozzo F, Velo G, Burzilleri L, Montanaro N, Conforti A. Adverse drug reactions related to the use of fluoroquinolone antimicrobials an analysis of spontaneous reports and fluoroquinolone consumption data from three Italian regions. Drug Saf 2003 26 109-20. 

Primary reports describing adverse reactions and drug-induced diseases include spontaneous reports and other unpublished data available from the manufacturer or the FDA. All reports of adverse reactions reported to the FDA can be retrieved (without identifiers) under the legal authority of the Freedom of Information Act. Anecdotal and descriptive reports of ADRs (including case reports and case series) are occasionally reported in the literature but are often incomplete and inconclusive. Guidelines for evaluating adverse drug reaction reports have been described (56). 

Rossi, A. Knapp, D. Discovery of new adverse drug reactions. A review of the food and drug administration s spontaneous reporting system. JAMA 1984,252,1030-1033. 

In a review of definite or probable drug-associated pancreatitis spontaneously reported to the Dutch adverse drug reactions system during 1977-98, azathioprine was the suspected drug in four of 34 patients, two of whom had positive rechallenge (37). Although most of the carefully described reports of azathioprine-induced pancreatitis were found in patients with inflammatory bowel disease, transplant recipients can also suffer this complication. 

Ciucci AG. A review of spontaneously reported adverse drug reactions with diclofenac sodium (Voltarol). Rheumatol Rehabil 1979 (Suppl 2) 116-21. 

A definite case of pancreatitis proven by positive rechallenge was also briefly cited in a review of drug-associated pancreatitis spontaneously reported to the Dutch adverse drug reactions system (261). 

Evans SJW, et al. 2001. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepi-demiol. Drug Safety 10 483-486. 

Roeser, H.P. Rohan, A.P. Post-marketing surveillance of drugs. The spontaneous reporting scheme Role of the Adverse Drug Reactions Advisory Committee. Med. J. Aust. 1990, 153, 720-726. 

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