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."
Taking Blood Pressure Pills at Night May Offer Benefits: Study
For certain people, it may be better to take high blood pressure medications at night instead of in the morning, says an Italian study in the December issue of the American Journal of Kidney Diseases.
The researchers concluded that this simple change may help normalize blood pressure patterns in people at increased risk from heart and kidney disease, the Canadian Press reported.
In healthy people, blood pressure drops by 10 percent to 20 percent during sleep. Scientists suspect that this may occur in order to give arteries a bit of rest. People with hypertension who don't experience this blood pressure dip at night are more likely to develop serious heart disease than other hypertension patients who do experience the dip.
People with chronic kidney disease are most likely to be "non-dippers," which increases their risk of worsening kidney damage and heart disease.
In this study, 32 non-dippers with kidney disease started taking a high blood pressure drug at night instead of in the morning, the CP reported. Within two months, nearly 90 percent had turned into dippers, with an average seven-point drop in nighttime blood pressure. There were also signs of improved kidney function. The patients experienced no side effects or increases in daytime blood pressure.
European Commission Approves Once-a-Day HIV Pill
European regulators have approved the once-a-day HIV pill Atripla, which combines three existing drugs (efavirenz, tenofovir and emtricitabine). The pill will soon be available to HIV patients in a number of European countries, BBC News reported.
Atripla was approved in the United States in July last year and is now given to about half of all newly diagnosed HIV patients.
Early HIV drug therapy required patients to take as many as 30 pills on an empty stomach at different times, BBC News reported. That had been reduced to just several pills a day for newly -diagnosed HIV patients. This new pill further simplifies the mediation regimen.
Atripla was developed through a collaboration of three drug makers -- Gilead Sciences, Bristol-Myers Squibb and Merck.
"This is a big advance for patients. It almost normalizes HIV," Dr. Simon Portsmouth, a leading HIV consultant, told BBC News. "They can just take this pill before they go to bed at night, and it doesn't take over their whole life."
Canadian Reactor Resumes Production of Medical Isotopes