The European Medicines Agency announced on Friday that it had initiated a review of the cardiovascular safety of ibuprofen when taken in high doses over an extended period of time. The review will be performed by the Pharmacovigilance Risk Assessment Committee (PRAC). … Click here to read the full post on Forbes. …
Sharp Scrutiny From European Medicines Agency Of Amgen And Servier Heart Drug
June 12, 2014 by Leave a Comment
There may be trouble on the horizon for ivabradine, a heart drug marketed by Servier under the brand names of Corlentor and Procoralan. The drug is widely available in Europe and elsewhere, though it is not available in the US, where it is under development by Amgen. Although it hasn’t been widely noticed– I can find no other…
European Medicines Agency Starts Review of Combined Use Of Drugs That Block The Renin-Angiotensin System
May 20, 2013 by 1 Comment
The European Medicines Agency said last week that it was initiating a review of the combined use of agents that block the renin-angiotensin system (RAS). The three classes of RAS-blocking drugs (ACE inhibitors, ARBs, and direct renin inhibitors) are used to treat hypertension and congestive heart failure. The EMA said that the review was being performed to…
Pradaxa To Be Contraindicated In Patients With Mechanical Heart Valves
December 18, 2012 by 1 Comment
Boehringer Ingelheim is starting to inform physicians about a new contraindication for its oral anticoagulant drug Pradaxa (dabigatran). The company has told investigators in trials utilizing dabigatran that it will shortly be sending a “Dear Doctor Letter,” also known as a Direct Healthcare Professional Communication (DHPC), to healthcare professionals. The letter will inform physicians that…
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