New Hypertension Drug Gets FDA Approval
First approved blood pressure treatment that acts by inhibiting renin
WEDNESDAY, March 7 (HealthDay News) -- The U.S. Food and Drug Administration has approved a new drug for hypertension called Tekturna (aliskiren), which acts by inhibiting renin. The drug is effective with results sustained for up to a year, although it is less effective in black patients than whites and Asians. Its efficacy is boosted by concurrent use of the diuretic hydrochlorothiazide.
The drug, manufactured by Novartis Pharmaceuticals in East Hanover, N.J., was tested in six placebo-controlled eight-week clinical trials including over 2,000 patients with mild to moderate hypertension.
Reported side effects from safety tests conducted on 6,460 patients included diarrhea, which affected approximately 2 percent of patients who took the higher of the two approved doses, and there were rare cases of allergic reaction. As with other drugs that have a direct effect on the renin-angiotensin system, Tekturna is not suitable for use during pregnancy due to the risk to the fetus.
"Hypertension is rightly called 'the silent killer' because it usually has no symptoms until it causes major damage to the body organs," said Douglas C. Throckmorton, M.D., FDA's deputy director of the Center for Drug Evaluation and Research, in a statement. "Today's approval adds a new safe and effective treatment option for people who need help to control their blood pressure."