Rasilez (Aliskiren) – a blood pressure drug sold as Tekturna in the U.S. – has health regulators in the U.K. concerned, as they’ve announced new contraindications and warnings regarding the drug.
According a Drug Safety Update issued by the Medicine and Healthcare Products Regulatory Agency, the use of Aliskiren in combination with two types of heart drugs called ACE inhibitors and Angiotensin II receptor blockers (ARB) is now contraindicated in type 1 and type 2 diabetics, as well as patients with kidney impairment.
Aliskiren was brought to market as Rasilez and Tekturna in 2007, and Novartis had high hopes that the drug would become a best-seller. It is approved as a treatment for hypertension (high blood pressure) either as monotherapy or in combination with other medications.
However, an independent review committee noted higher adverse events in patients receiving Rasilez/Tekturna in a trial clinical study called “Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE).”
The ALTITUDE study was designed to evaluate the effect of Aliskiren on the likelihood of cardiovascular and kidney events in high-risk diabetic patients. On the basis of preliminary interim analyses, the Data Monitoring Committee concluded that study patients were unlikely to benefit from Aliskiren.
There was also an increased incidence after 18 to 24 months of serious side effects in the high risk population, including non-fatal stroke, kidney complications, hyperkalemia (high potassium), and hypotension (low blood pressure).
In January, Novartis agreed to a request from European regulators to add new safety warnings to the labels of Aliskaren products to reflect the findings of the ALTITUDE trial.