Timeline: Tekturna/Rasilez (aliskiren)


timeline Tekturna Rasilez (aliskiren)Mar. 5, 2007: The U.S. Food and Drug Administration (FDA) approves Novartis’ Tekturna as once-daily oral therapy to treat high blood pressure. Tekturna may be taken alone or in combination with other medications used to treat high blood pressure.

May 2007: The American Journal of Hypertension publishes a study that raises questions about Tekturna’s effectiveness. Researchers analyzed 5,000 patients among six clinical trials who were diagnosed with hypertension. Overall, the findings indicated that Tekturna is not more effective at lowering high blood pressure when compared to angiotensin-converting enzyme inhibitors (CEIs), angiotensin receptor blockers (ARBs) or diuretics.

May 2008: The FDA updates the safety labeling to contraindicate use with cyclosporine, an immunosuppressant.

Jul. 2009: The FDA approves Tekturna as first-line treatment in patients who will mostly likely rely on multiple medications in order to achieve a health blood pressure.

Dec. 2011: Novartis stops its ALTITUDE trials, clinical studies meant to determine whether Tekturna would be able to reduce the risks of cardiovascular events and kidney impairment in patients with type II diabetes. The trial was stopped after a review committee discovered that the Tekturna users were experiencing an elevated rate of non-fatal stroke, renal complications hyperkalenia (high potassium) and hypotension (low blood pressure) on top of standard trial treatment.

Dec. 2011: The EMA begins a safety review of Tekturna. The agency has instructed doctors to stop prescribing the medication to elderly patients who are taking other types of high blood pressure medication.

Jan. 2012: Tekturna will undergo a safety review in Canada, following the outcome of the  ALTITUDE trials.

Jan. 23, 2012: Health Canada updates the label for Tekturna, contraindicating the medication in patients who are taking ACE inhibitors and ARBs in patients with type II diabetes.

Mar. 8, 2012: The Medicines and Healthcare products Regulatory Agency (MHRA) releases new warnings about Tekturna (sold as Rasilez). Based on the ALTITUDE trial, the agency warns that when combined with angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), use of Tekturna may be associated adverse effects on cardiovascular and renal health.  

Apr. 22, 2012: In accordance with FDA’s requests, Novartis updates the safety information on Tekturna and Tekturna HCT. The medication is now contraindicated in US patients who have diabetes or moderate renal impairment (GFR< 60 mL/min) taking ACE inhibitors or ARBs.

Oct. 2012: According to the ISMP’s QuarterWatch report for first quarter 2012, the number of serious adverse event reports reported to the U.S. Food and Drug Administration has increased 90 percent in the past four years. The report, which focused on Tekturna, Actos, Cymbalta and Xarelto, stated that the FDA received 100 adverse event reports related to Tekturna; the most common side effects included angioedema, rapid swelling that can block the airway.

Nov. 3, 2012: The New England Journal of Medicine publishes a study evaluating the effects of Tekturna in Type 2 diabetics with chronic kidney disease, cardiovascular disease or both. At median follow-up, 18.3 % of patients taking Tekturna had experienced the primary endpoint, which included: “cardiovascular death or a first occurrence of cardiac arrest with resuscitation, nonfatal myocardial infarction, nonfatal stroke, unplanned hospitalization for heart failure,end-stage renal disease, death attributable to kidney failure, or the need for renal-replacement therapy with no dialysis or transplantation available or initiated, or doubling of the baseline serum creatinine level.” Comparatively, the primary endpoint occurred in 17.1% of the placebo group. The authors concluded that “The addition of aliskiren to standard therapy with renin–angiotensin system blockade in patients with type 2 diabetes who are at high risk for cardiovascular and renal events is not supported by these data and may even be harmful.”