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| November 2002, Volume 16, Number 11, Pages 795-803 |
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| Original Article |
| The safety of valsartan: results of a postmarketing surveillance study on 12 881 patients in England |
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| P N Biswas1, L V Wilton1 and S W Shakir1,2 |
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1Drug Safety Research Unit, Bursledon Hall, Southampton SO31 1AA, UK
2London School of Hygiene and Tropical Medicine, London, UK
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Correspondence to: Dr PN Biswas, Drug Safety Research Unit, Bursledon Hall, Blundell Lane, Southampton S031 1AA, UK. E-mail: pipasha.biswas@dsru.org |
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| Abstract |
| Valsartan is a second class of angiotensin II receptor antagonist, indicated for the treatment of hypertension. The objective of the study was to monitor the safety of valsartan using the technique of prescription event monitoring (PEM), in patients who were prescribed this drug by general practitioners (GPs) in England. PEM is a noninterventional observation cohort technique. Exposure data were obtained from dispensed prescriptions issued between December 1996 and November 1998. Outcome data were obtained by sending questionnaires to prescribing GPs. The cohort comprised 12 881 patients. Events most frequently reported as suspected adverse drug reactions were malaise/lassitude (37; 0.3% of total cohort), dizziness (19; 0.1%), and unspecified side effects (57; 0.4%). Events with the highest incidence density (ID1 per 1000 patient-months of treatment) in the first month of treatment were malaise/lassitude (15.6), dizziness (11.8), and headache/migraine (10.9). Most frequent reasons for stopping valsartan were not effective (847; 6.6% of total cohort), malaise/lassitude (265; 21%), and dizziness (146; 1.1%). No unexpected serious adverse events were identified. Other events assessed as possibly related to valsartan use were impotence (37), dizziness (19), cough (9), facial oedema (5), hyperkalaemia (3), and angioneurotic oedema (1). There were four reports of exposure during pregnancy and 203 deaths (1.5%) in this cohort. In conclusion, this study monitored the safety profile of valsartan in a large cohort of patients in general practice in England. No untoward features other than dizziness were identified that were not mentioned in the prescribing guidance. Journal of Human Hypertension (2002) 16, 795-803. doi:10.1038/sj.jhh.1001490 |
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| Keywords |
| valsartan; prescription event monitoring; safety; adverse drug reactions |
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| Received 29 May 2002; accepted 6 September 2002 |
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| November 2002, Volume 16, Number 11, Pages 795-803 |
| Table of contents Previous Abstract Next Full text PDF |
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