According to the CDC, approximately 70 million adults in the U.S. have hypertension—high blood pressure—and only about half of those people have their condition under control. Including the cost of medication, days missed from work, and necessary healthcare, the cost of high blood pressure costs America over $45 billion annually. Tekturna, a medication manufactured by Novartis, has been prescribed to patients to control their high blood pressure. However, this drug has also been linked to serious complications in type 2 diabetics, and affected patients may be eligible for compensation.
What Is Tekturna?
Tekturna is taken once daily to treat high blood pressure and can be used alone or in combination with other blood pressure medications. First approved by the FDA in March 2007, the genetic form of this drug is known as aliskiren. In Europe, Tekturna is marketed under the brand name Rasilez.
Tekturna works by tracking renin, an enzyme in the body and bloodstream that is connected to a process of narrowing blood vessels. When renin is inhibited, blood vessels relax and blood flows more freely. This lowers a patient's blood pressure.
Side Effects Associated With Tekturna
The most common side effects of Tekturna include dizziness, headache, back pain, tiredness, flu-like symptoms, diarrhea, cough, and vertigo. However, Tekturna is also associated with two very serious side effects: hyperkalemia and stroke. The risk of these serious side effects appears to increase after a patient has taken Tekturna for 18-24 months.
Hyperkalemia is a kidney condition characterized by elevated levels of potassium. In extreme cases, hyperkalemia can cause potentially fatal abnormal heart rhythms. Hyperkalemia can be difficult to diagnose because its symptoms overlap with a number of other conditions. Patients may experience chest pain, numbness, tingling, weakness, fatigue, and/or heart palpitations. A blood test can provide a definitive diagnosis.
Patients with hyperkalemia are treated with hemodialysis, which involves using a machine to remove waste from the blood. Patients may also be given diuretics to stimulate urine production, since this will lower potassium levels.
Another serious side effect of Tekturna is the increased risk of patients experiencing non-fatal strokes caused by blood clots or bleeding in the brain. A patient who is experiencing a stroke will notice warning signs such as blurred vision, slurred speech, difficulty walking or balancing, muscle weakness, confusion, headache, and dizziness. Loss of consciousness can also occur when a patient is having a stroke.
What Is the Basis of the Legal Action Against Novartis?
Novartis is currently at the center of multiple lawsuits related to Tekturna. Evidence of the harmful side effects of Tekturna comes from a multinational ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints) study involving over 8,600 patients. Participants were given Tekturna with an angiotensin converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) to look at how effective the treatment would be in reducing heart and kidney events for type 2 diabetics. The study was halted prematurely when evidence showed patients gained no significant benefit from the drug but experienced a high risk of hyperkalemia and stroke.
The company has also come under fire because evidence showed it encouraged off-label marketing of Tekturna to diabetic patients, even though the drug was not indicated for this purpose. The Federal Food, Drug, and Cosmetic Act makes it illegal for pharmaceutical companies to market their products for uses not approved by the FDA. Companies that do so open themselves up to civil liability under the False Claims Act, as well as various criminal penalties.
You May Be Entitled to Compensation
Only patients who took Tekturna and experienced serious side effects are eligible for compensation. If you were diagnosed with hyperkalemia or had a stroke after taking Tekturna, you may be entitled to compensation for medical expenses, lost wages, and pain and suffering.
To pursue legal action against Novartis, you'll need to enlist the services of an attorney skilled in the complex litigation of cases involving dangerous drugs. Neblett, Beard & Arsenault is committed to helping the men and women harmed by Tekturna receive the compensation they need to move forward with their lives. Schedule a free consultation at one of our six convenient office locations to learn more. You can also call us directly at 800.256.1050.