FDA OKs New High Blood Pressure Drug
Tekturna Is First in a New Class of Blood Pressure Drugs
March 6, 2007 -- The FDA today approved a new drug called Tekturna to treat
hypertension (high blood pressure).
Tekturna is the first FDA-approved drug in a new class of high blood
pressure drugs called renin inhibitors. The kidneys make renin, an enzyme, to
help regulate blood pressure.
Renin can raise blood pressure. Tekturna, taken once daily by mouth, blocks
"Hypertension is rightly called 'the silent killer' because it usually
has no symptoms until it causes major damage to the body organs," says the
FDA's Douglas Throckmorton, MD, in an FDA news release.
Throckmorton is the deputy director of the FDA's Center for Drug Evaluation
"Today's approval adds a new safe and effective treatment option for
people who need help to control their blood pressure," Throckmorton
The FDA says Tekturna's effectiveness in lowering blood pressure was
demonstrated in six clinical trials that included more than 2,000 people with
mild to moderate hypertension.
Patients either got Tekturna or a sugar pill (placebo).
Tekturna lowered blood pressure more than the placebo, says the FDA.
Tekturna significantly reduced blood pressure for 24 hours, states a news
release from Novartis, the drug company that makes Tekturna.
Tekturna's blood pressure effects lasted for up to one year and was greater
when Tekturna was taken with a diuretic, or water pill, according to the
In the clinical trials, Tekturna's side effects were usually mild and brief,
according to the FDA.
Diarrhea was the most common side effect associated with Tekturna. About 2%
of the patients taking the higher of two Tekturna doses had diarrhea, compared
with about 1% of those taking the placebo, states the FDA.
Other less common side effects included cough and rash, according to
The FDA notes rare cases of allergic reactions in patients taking Tekturna.
Those allergic reactions swelled the face, lips, or tongue, making breathing
difficult. Such allergic reactions have been seen with certain other types of
blood pressure drugs, the FDA notes.
Tekturna is one of several blood pressure drugs that should not be taken
during pregnancy because it may cause injury or death to the developing
Novartis says it will do a large trial to track Tekturna's long-term
effects. Novartis is a WebMD sponsor.