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Safety of blood pressure drug Rasilez reviewed

Health Canada is reviewing the safety of the blood-pressure drug Rasilez after a clinical study was stopped early by its manufacturer because the drug could potentially lead to harm when combined with other medications to lower blood pressure.

Novartis, the manufacturer of Rasilez, announced this week that it was halting a multinational clinical trial that was designed to see whether adding the drug to conventional treatments in people with Type 2 diabetes and kidney impairment could reduce the risk of heart and kidney problems.

Data from the clinical trial suggested Rasilez (the brand name for aliskiren) was unlikely to benefit these patients participating in the clinical trial and could potentially lead to harm, Health Canada said.

"Specifically, when used in combination with other blood pressure-lowering drugs known as angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), Rasilez was associated with an increased risk of non-fatal stroke, kidney complications, hyperkalemia (high levels of potassium in the blood) and low blood pressure," the regulator said in a release Thursday.

Health Canada said it is evaluating safety information from the company and other regulators worldwide to determine if regulatory actions are needed, such as strengthening the drug labelling information.

Novartis said it is in discussions with global health authorities about the implications of the findings from the clinical trial.

"As a precautionary measure Novartis will cease promotion of Rasilez/Tekturna-based products for use in combination with an ACE-inhibitor or ARB," the company said in a statement.

Patients in the clinical trial, known as ALTITUDE, should contact their study site for guidance on medication and should not stop treatment until they have seen their doctor, because of the importance of controlling high blood pressure, Novartis and Health Canada advised.

The clinical trial involved 8,606 patients from 36 countries worldwide. Health Canada said the company confirmed 329 of the patients are from Canada.