Tekturna Kidney Damage Warning Added to Labels in Europe
European drug regulators are calling for new kidney damage warnings for Tekturna and other drugs containing the active ingredient aliskiren.
The new warnings and contraindications were announced by the European Medicines Agency (EMA) on Friday.
Tekturna (aliskiren) is manufactured by Novartis and was first approved in the United States in 2007 for the treatment of hypertension. In Europe and other countries outside of the United States, the mediation is sold under the brand name Rasilez.
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The EMA recommended that combinations of Tekturna with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) be contraindicated in patients with diabetes or moderate to severe renal (kidney) impairment. European officials say that the drug can be more risk than benefit to diabetes patients and those with kidney problems being given ACE inhibitors or ARBs and is recommending that doctors with patients in those situations seek another drug for controlling high blood pressure.
The decision comes after a Novartis cancelled a Tekturna clinical trial known as ALTITUDE due to a sharp spike in the number of strokes and kidney problems among test subjects. The study was an attempt to see if Tekturna could help diabetes patients with kidney problems.
The research suggested that Tekturna side effects may increase the risk of not only strokes and kidney damage, but also may cause hypotension (low blood pressure) and hyperkalemia (high potassium), both of which can cause circulatory problems, such as a low pulse and heart rate.
The ALTITUDE trial involved the use of Tekturna along with ACE inhibitors or ARBs. As a result, Novartis says it will cease promoting the use of Tekturna in combination with those drugs in any patients. The EMA says data from the studies seems to confirm that the combinations were likely the cause of the health problems seen in the trial. The company is in consultations with governments worldwide about Tekturna health risks.
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