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A comparison of two cohort studies evaluating the safety of cisapride: Prescription-Event Monitoring and a large phase IV study (1997)

Wager, E. ; Tooley, P. J. H. ; Pearce, G. L. ; [et al.]

Springer

European journal of clinical pharmacology 52 (1997), S. 87-94

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ISSN: 1432-1041

Keywords: Key words Prescription-Event Monitoring ; Cisapride; pharmacovigilance ; adverse drug reactions ; post-marketing surveillance

Source: Springer Online Journal Archives 1860-2000

Topics: Chemistry and Pharmacology , Medicine

Notes: Abstract Objective: The results of Prescription-Event Monitoring (PEM) from over 13 000 patients receiving cisapride are compared with safety data from a large-scale clinical study involving nearly 10 000 patients. Results: The clinical study population showed a significantly younger age profile than the PEM population and excluded patients with serious disease; however, both studies showed similar patterns of adverse events. The most common adverse events reported in association with cisapride in both studies were diarrhoea, headache, abdominal pain, constipation and nausea. Some of these may be attributed to the underlying condition rather than the action of the drug. Prompting patients about adverse events during a clinical trial assessment appeared to increase the reporting of some conditions: for example, diarrhoea was reported more frequently in the clinical trial than in the PEM study. Conclusion: Both studies showed cisapride to be generally safe and well tolerated.

Type of Medium: Electronic Resource

URL: http://dx.doi.org/10.1007/s002280050255

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The outcomes of pregnancy in women exposed to newly marketed drugs in general practice in England (1998)

Wilton, L. V. ; Pearce, G. L. ; Martin, R. M. ; [et al.]

Oxford, UK : Blackwell Publishing Ltd

BJOG 105 (1998), S. 0

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ISSN: 1471-0528

Source: Blackwell Publishing Journal Backfiles 1879-2005

Topics: Medicine

Notes: Objective To determine the proportion and nature of congenital anomalies in babies born to women exposed to newly marketed drugs during the first trimester.Design Non-interventional observational cohort studies.Methods The women were identified in confidence by the Prescription Pricing Authority. The doctor was sent a questionnaire to determine clinical events, including pregnancy, occurring after the drug was dispensed. A supplementary questionnaire determined the outcome of each reported pregnancy.Setting General medical practice in England.Population Women exposed to newly marketed drugs in whom pregnancy was recorded.Main outcome measures Outcomes of pregnancies, the proportion and nature of congenital anomalies in the babies born.Results 2511 pregnancies were reported. In 831 of these pregnancies a newly marketed drug had been taken during the first trimester and in 74 during the secondkhird trimester. The outcome was ascertained for 780 (94%) of these 831 pregnancies: 547 (66%) births; 10 (1%) ectopic pregnancies; 94 (11%) spontaneous miscarriages; 5 (〈 1%) missed abortions; 120 (14%0) legal abortions; and 4 (C 1%) intrauterine deaths. 557 infants were born, of whom 14 (2.5%) had congenital anomalies.Conclusions The proportion of live infants with a congenital abnormality born to mothers exposed to newly marketed drugs in the first trimester was similar to the percentage of congenital anomalies estimated by the Ofice for National Statistics. These data add valuable information to the safety database of these drugs.