PPIs heart safe
This article was originally published in The Tan Sheet
Executive Summary
Use of AstraZeneca's proton-pump inhibitor Prilosec (omeprazole) or the follow-on Nexium (esomeprazole) does not increase the risk of cardiovascular events, according to a Dec. 10 statement by FDA. The administration assessed two small, long-term studies on Prilosec and Nexium reported earlier this year - both of which had raised a question as to whether long-term use of the drugs increased the number of heart attacks, heart failures and heart-related sudden death - as well as 14 comparative studies of Prilosec, four of which were placebo-controlled. FDA announced in August that it was conducting the greater review of safety data but based on preliminary data, health-care providers and patients should not change their prescribing or use practices, respectively (1"The Tan Sheet" Aug. 13, 2007, p. 3). Based on the now complete comprehensive, scientific review, FDA concluded that the frequency of cardiovascular events seen in the earlier analyses does not indicate the presence of a true effect...
You may also be interested in...
Canada on omeprazole
Long-term use of Nexium does not increase the risk of cardiovascular events, Health Canada announces Feb. 27. Additionally, the agency says it is unable to conclude definitively whether long-term use of Losec (omeprazole) increases cardiovascular risk, and will continue to evaluate it if more data emerge. The agency recommends patients taking either drug not change their medication unless directed by their doctor, "as ulcers and reflux can lead to other complications if left untreated." FDA conducted its own safety review of the products in August after study results raised questions about long-term use of the drugs and cardiovascular outcomes. However, the agency concluded the data did not indicate the presence of a true effect (1"The Tan Sheet" Dec. 17, 2007, In Brief)...
FDA To Complete Prilosec, Nexium Safety Review In November, CDER Says
FDA is continuing to investigate safety data on AstraZeneca's proton pump inhibitors Prilosec and Nexium (omeprazole and esomeprazole, respecttively), but announced a preliminary conclusion the drugs do not present an increased cardiovascular risk
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”