Losartan: a study of pharmacovigilance data on 14 522 patients

Abstract

The objective of this study was to undertake a postmarketing safety surveillance study of losartan, the first specific angiotensin-II receptor antagonist to be marketed in England. It is a non-interventional observational cohort study using the technique of prescription-event monitoring. Subjects who took part in the study were from 14 522 patients treated by general practitioners in England. We recorded adverse drug reactions, adverse events, reasons for stopping the drug, pregnancies and deaths. The results were that general practitioners considered the drug to have been effective in 85.9% of the

The safety of valsartan: results of a postmarketing surveillance study on 12 881 patients in England

“…11 The response rate for the losartan PEM study was similar at 54.6%. 12 The green forms were sent to the prescribers 6 months after the first prescription of valsartan; thus, a limitation of the study is the lack of capture of any events which occurred more than 6 months after the first prescription. This study is the largest safety study of valsartan so far reported (MEDLINE and EMBASE search criteria).…”

“…This is similar to the results with losartan (82.5%). 12 Also, it was said to have been effective in 84.8% of the 11 191 patients for whom the GPs gave an opinion regarding effectiveness.…”

“…16 Angioedema is a well-recognized adverse effect of ACE inhibitors thought to be due to the accumulation of bradykinin. There are several reports in the literature of angioedema 17 during exposure to losartan, including four possible cases in the PEM study of losartan 12 . Angioedema occurred once in 3204 patients exposed to valsartan in the randomised controlled trails quoted in the valsartan SmPC.…”

Medication Use in Pregnancy; Treating the Mother: Protecting the Unborn

“…Based on limited data from first trimester exposure (Walfisch et al 2011;Schaefer 2003;Gersak et al 2009;Serreau et al 2005;Chung et al 2001;Biswas et al 2002;Mann et al 1999), there does not appear to be an elevated risk of major congenital malformations above the risk in pregnant hypertensive women, untreated or treated with other medications.…”

Angiotensin receptor antagonists and vaso-vagal attacks due to sensitisation of the Bezold-Jarisch reflex?

“…Nevertheless post marketing surveillance studies report 'dizziness' as one of the most common symptoms reported by patients taking these drugs. 5 The identification of an uncommon side effect of a drug requires clinical vigilance and clinicians should be aware of this possible adverse reaction to angiotensin receptor blocking drugs, particularly in view of their increasing use in the management of hypertension and heart failure. …”