Prescription event monitoring studies

Layton D, Riley J, Wilton LV, et al. Safety profile of rofecoxib as used in general practice in England results of a prescription-event monitoring study. Br J Clin Pharmacol 20(B 55 166-74. 

Mann RD, Pearce GL, Dunn N, Shakir S. Sedation with non-sedating antihistamines four prescription-event monitoring studies in general practice. BMl 2000,320 1184-1187. 

The frequency of sedation due to acrivastine, cetirizine, fexofenadine, and loratadine has been investigated in four prescription-event monitoring studies in 43 363 patients in general practice in the UK (53). Prescriptions were obtained for each cohort in the immediate postmarketing period. Sedation and drowsiness were the main outcome measures. The odds ratios (adjusted for age and sex) for the incidences of sedation compared with loratadine were 0.63 (95% Cl = 0.36, 1.11) for fexofenadine, 2.79 (1.69, 4.58) for acrivastine, and 3.53 (2.07, 5.42) for cetirizine. There was no increased risk of accident or injury with any of the four drugs. 

In 1986, the UK Drug Safety Research Unit at Southampton published a report on its prescription event monitoring study of etodolac (SEDA-13, 80). Etodolac was rated effective in only 56% of 9109 patients, and the Unit concluded that the average dosage used... 

In a Prescription-Event Monitoring study in 3085 patients, mean age 65 years, the commonest reported adverse events and reasons for stopping were malaise/ lassitude, dizziness, edema, and headache (7). 

The risk of ACE inhibitor-induced renal impairment in patients with or without renovascular disease can be potentiated by diuretics. " In an analysis of 74 patients who had been treated with captopril or lisinopril, reversible acute renal failure was more coimnon in those who were also treated with a diuretic (furosemide and/or hydrochlorothiazide) than those who were not (11 of 33 patients compared with 1 of 41 patients). Similarly, in a prescription-event monitoring study, enalapril was associated with raised creatinine or urea in 75 patients and it was thought to have contributed to the deterioration in renal function and subsequent deaths in 10 of these patients. However, 9 of these 10 were also receiving loop or thiazide diuretics, sometimes in high doses. Retrospective analysis of a controlled study in patients with hypertensive nephrosclerosis identified 8 of 34 patients who developed reversible renal impairment when treated with enalapril and various other antihypertensives including a diuretic (furosemide or hydrochlorothiazide). In contrast, 23 patients treated with placebo and various other antihypertensives did not develop renal impairment. Subsequently, enalapril was tolerated by 7 of the 8 patients without deterioration in renal function and 6 of these patients later received diuretics. One patient was again treated with enalapril with recurrence of renal impairment, but discontinuation of the diuretics (furosemide, hydrochlorothiazide, and triamterene) led to an improvement in renal function despite the continuation of enalapril. ... 

Buggy Y, Layton D, Fogg C, Shakir SA. Safety profile of oxcarbazepine results from a prescription-event monitoring study. Epilepsia 2010 51(5) 818-29. 

S] Lampl C, Schweiger C, Haider B, Lechner A. Pregabalin as mono- or addon therapy for patients with refractory chronic neuropathic pain a postmarketing prescription-event monitoring study. J Neurol 2010 257(8) 1265-73. 

Osborne V, Layton D, Perrio M, Wilton L, Shakir SA. Incidence of venous thromboembolism in users of strontium ranelate an analysis of data from a prescription-event monitoring study in England. Drug Saf 2010 33(7) 579-91. 

Vickova V, Cornelius V, Kasliwal R, Wilton L, Shakir S. Hypoglycaemia with pioglitazone analysis of data from the prescription-event monitoring study. J Eval Clin Pract 2010 18 1124-8. 

Kasliwal R, Wilton LV, Shakir SAW. Monitoring the safety of pioglitazone results of a prescription-event monitoring study of 12 772 patients in England. Drug Saf 2008 31 839-50. 

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