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Novartis Prematurely Halts Study on Tekturna, Citing Serious Side Effects

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Approved in 2007 for use as a treatment for high blood pressure, Tekturna (aliskiren) has recently come under scrutiny because of reports of serious Tekturna side effects.

In December 2011, manufacturer Novartis stopped advertising Tekturna and issued a press release detailing the findings from a recent study, which showed that patients with type 2 diabetes and kidney impairment who take Tekturna are at a significantly higher risk of non-fatal stroke, kidney complications, hyperkalemia (high potassium levels), and low blood pressure.

Meanwhile, patients who have suffered from these injuries may be eligible to file a Tekturna lawsuit. A thorough evaluation with a Tekturna lawyer can help determine whether or not an individual case may prove successful in court.

What is Tekturna?

Tekturna is a high blood pressure medication that may be used alone or in conjunction with other high blood pressure medications like ACE inhibitors. At the time of its approval by the FDA, it was the first of a new class of high blood pressure drugs called "renin inhibitors," which block the enzyme renin from elevating blood pressure.

In an attempt to expand the use of Tekturna as a protective agent for cardiovascular and kidney conditions, Novartis launched several new studies to test the long-term use of the drug, including a clinical trial called the "ALTITUDE" trial. Unfortunately, the results of that trial backfired on the manufacturer.

The ALTITUDE Trial Illuminates New Tekturna Side Effects

This trial involved over 8,500 patients from 36 countries, all of whom had type 2 diabetes and kidney impairments. The purpose of the trial was to test whether or not Tekturna, in combination with an ACE inhibitor or angiotensin receptor blocker (ARB), may reduce the risk of cardiovascular and kidney events in this population. In December 2011, however, Novartis halted the trial.

An independent review committee had discovered that those patients taking Tekturna were reporting a higher number of serious Tekturna side effects, particularly after 18–24 months. These included those mentioned above: stroke, kidney problems, hyperkalemia, and hypotension. Based on a recommendation by the Data Monitoring Committee (DMC) overseeing the study, Novartis recommended that ALTITUDE researchers remove Tekturna drugs from their patients' treatment regimens, and sent a letter to all physicians advising them to stop prescribing Tekturna to diabetic patients who also take an ACE inhibitor or ARB.

In a press release published December 20, 2011, Novartis indicated that sales of Tekturna were likely to be negatively impacted by the study results going forward.

FDA Warns of New Tekturna Side Effects

On April 20, 2012, the FDA released a new Drug Safety Communication notifying doctors of the possible risks when using drugs like Tekturna with other high blood pressure drugs and in patients with diabetes or kidney impairment. Novartis also announced that they will be making changes to the warning labels to alert patients to the risks.

Diabetic and kidney-impaired patients who have been impacted by Tekturna side effects are likely to be understandably upset that they weren't warned prior to this of the risks associated with taking the drug. These patients may consult with a Tekturna lawyer about filing a Tekturna lawsuit that may result in damages awarded in court. Already, Novartis has paid $422 million to settle a U.S. Department of Justice and whistleblower lawsuit, which involved allegations that the company had paid illegal kickbacks to healthcare professionals to induce them to prescribe Tekturna, among other medications.