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FDA raises concerns about Benicar

The FDA is evaluating data linking Daiichi Sankyo's Benicar to an increased risk of cardiovascular death in type II diabetes patients

The US Food and Drug Administration (FDA) has issued an alert stating that it is evaluating clinical data that may link Daiichi Sankyo's blood-pressure drug Benicar (olmesartan) to an increased risk of cardiovascular death in type II diabetes patients.

The FDA stressed that it is still examining the data and that it has not yet reached any final conclusions, adding that its current position is still that the drug's benefits outweigh its risks.

However, the agency expressed concern about the potential implications of two large-scale, long-term clinical trials in which type II diabetes patients taking Benicar had a higher rate of death from cardiovascular causes compared to patients on placebo.

Both of the studies were intended to test whether Benicar might slow the progression of kidney disease in patients with type II diabetes and unexpectedly turned up the finding that the patients taking Benicar showed a higher risk of death from heart attack, sudden death, or stroke than those in the placebo group.

Other controlled clinical trials evaluating Benicar and related drugs in the angiotensin II receptor blocker class have not suggested an increased risk of cardiovascular-related death, according to the FDA.

Benicar already carries a boxed warning advising against use during pregnancy, as well as a number of other warnings. The drug was approved by the FDA for treatment of hypertension in adults in 2002, and earlier this year won an additional US approval for use in children and adolescents ages six to 16.

15th June 2010

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