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As of February 2012, there is a Tetkturna black box warning related to potential harm on developing fetuses.
The specific warning reads:
Do not take aliskiren if you are pregnant. If you become pregnant while taking aliskiren, call your doctor immediately. Aliskiren may harm the fetus.
While this is currently the only Tekturna black box warning, there are other concerns. Recent information indicates that Tekturna problems may also include heart injuries, kidney problems and stroke.
Novartis, the Tekturna manufacturer, recently ended its Altitude study because of the drug showed no added benefit and a potential risk for participants. Will the FDA review this information and adverse reports received by the agency to issue new Tekturna warnings? Only time will tell, but in the meantime it is important to talk to your doctor about whether Tekturna is an effective drug to treat your high blood pressure.