TUESDAY, Dec. 18 (HealthDay News) -- The U.S. Food and Drug Administration announced this week that it has approved Bystolic (nebivolol) for the treatment of hypertension. Bystolic is a beta blocker, a class of commonly prescribed antihypertensive medications that reduce the force of the heart's contraction.
The safety and efficacy of Bystolic was shown in three randomized, double-blind, multi-center, placebo-controlled trials. An additional placebo-controlled trial evaluated Bystolic in combination with other antihypertensive medications in patients with poorly controlled hypertension. In all, 2,000 patients were treated with Bystolic, and the drug's blood pressure-lowering efficacy was similar to that reported for other beta blockers.
The most commonly reported side effects of Bystolic in the clinical trials were headache, fatigue, dizziness and diarrhea.
"High blood pressure is often called the 'silent killer' because it usually has no symptoms until it causes damage to the body," comments Douglas C. Throckmorton, M.D., FDA's deputy director of the Center for Drug Evaluation and Research. "Bystolic offers a new treatment option for people who need to control their high blood pressure."
Bystolic is sponsored by Mylan Bertek Pharmaceuticals Inc. of Research Triangle Park, N.C., and sales and marketing rights are owned by Forest Laboratories, Inc. of New York City.
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