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The approval was based on findings from four studies in which more than 2,000 people received Bystolic. The drug's efficacy was similar to that of other FDA-approved beta blockers. Common side effects experienced by people taking Bystolic included headache, fatigue, dizziness and diarrhea.
Beta blockers are a well-established class of medications that lower blood pressure by reducing the force with which the heart pumps blood. Nearly one in three American adults has high blood pressure, which increases the risk of stroke, heart failure, heart attack, kidney failure and death.
"High blood pressure is often called the 'silent killer' because it usually has no symptoms until it causes damage to the body," Dr. Douglas C. Throckmorton, FDA's deputy director of the Center for Drug Evaluation and Research, said in a prepared statement. "Bystolic offers a new treatment option for people who need to control their high blood pressure."
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