FDA Finds Olmesartan Does Not Cause Cardiovascular Events


OlmesartanThe FDA concluded its safety review of the popular anti-hypertensive drug Olmesartan, also known as the brand name Benicar, in June 2014. There was no viable evidence found to cause the FDA to deem Olmesartan unsafe, and earlier concerns from study investigators claiming there was an increased risk for heart attack in patients taking Olmesartan was nullified. An FDA review commenced in 2010 when Phase III trial results from the ROADMAP, or Randomized Olmesartan and Diabetes Microalbuminuria Prevention study, showed patients with type 2 diabetes who were administered the drug experienced a greater number of cardiovascular deaths as compared to the placebo group. Additional studies were instituted at that time, including one large study of patients with Medicare, however none of these studies found any evidence linking the administration of Olmesartan with fatal or adverse cardiac events.

As a leading medication used to treat high blood pressure Olmesartan was prescribed to over 1.3 million patients in 2013. It is also a successful part of two combination drugs marketed by Daiichi Sankyo: Azor, which combines Olmesartan and Amlodipine and Tribenzor, which marries Olmesartan, Amlodipine and the diuretic hydrochlorothiazide. Products with Olmesartan were prescribed to roughly 1.8 million patients in 2013, although Benicar {Olmesartan} as monotherapy has eclipsed sales of all combination therapies. Patients ages six and older may safely be prescribed Olmesartan, which is in a class of medications deemed angiotensin II receptor antagonists. While tablet form of Olmesartan is most common a liquid form can be made for children who have trouble swallowing the tablet. Side effects can occur from Olmesartan, and include dizziness and a faint or light-headed feeling, particularly upon rising from a lying down or sitting position. People taking Olmesartan should be careful when first starting treatment with this drug and take their time upon standing. The majority of patients do not experience adverse effects from Olmesartan.

LGM Pharma is a provider of Olmesartan, CAS # 144689-63-4 API for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

 

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

 

  • Share: