If you have taken Amturnide to control your high blood pressure, you may already be aware that a recently clinical study found that Amturnide increases the risk of stroke, renal complications, low blood pressure, and toxic high levels of potassium in the bloodstream. Novartis, the drug company responsible for Amturnide, has ceased all promotion of this medication.
UPDATE: New Warnings on Amturnide Label
April 20, 2012 –The U.S. Food and Drug Administration (FDA) announced today that the labels on Amturnide and other aliskiren-containing drugs will be updated to include new risk information. In a Drug Safety Communication, the FDA warned doctors that Amturnide can cause kidney problems, dangerous low blood pressure (hypotension), or dangerously high levels of potassium in the bloodstream (hyperkalemia). The FDA advised doctors not to prescribe Amturnide with an ARB or ACE inhibitor to people with diabetes or kidney problems.
Amturnide is a prescription medication used to help lower high blood pressure (also called “hypertension”). It is manufactured by the pharmaceutical company Novartis, and was approved by the U.S. Food and Drug Administration (FDA) in December 2010.
Amturnide contains a combination of three medications:
- Aliskiren: A direct renin inhibitor (DRI), sold alone under the brand-name Tekturna.
- Amlopidine: A calcium-channel blocker, which relaxes smooth muscles
- Hydrochlorothiazide (HCTZ): A diuretic, which treats high blood pressure by helping the body get rid of excess fluid and salt in the bloodstream, making blood easier to pump
Amturnide is not indicated as a first-line treatment for high blood pressure, but rather, for patients who do not benefit from aliskiren alone (Tekturna) or aliskiren plus amlopidine (Tekamlo). Amturnide is only for people who have tried these combinations and need a stronger medication to reduce their high blood pressure.
It is estimated that, globally, one billion people suffer from high blood pressure, though most people do not receive adequate treatment. Around 50% of Americans with high blood pressure do not keep it under control. This is a problem, because high blood pressure increases the risk of heart attack, stroke, and death.
Physically, high blood pressure is caused by constricted, narrow blood vessels. More than 85% of people who treat high blood pressure take a combination of medications that help the smooth muscles along the blood vessels relax, thereby lowering blood pressure.
Several drugs that contain aliskiren are manufactured by Novartis. The Schmidt Firm, PLLC is currently accepting cases of severe, potentially life-threatening injuries caused by the following medications:
- Tekturna (aliskiren)
- Tekturna HCT (aliskiren and hydrochlorothiazide)
- Valturna (aliskiren and valsartan, an ARB)
- Tekamlo (aliskiren and amlodipine)
- Amturnide (aliskiren and amlodipine besylate, hydrocholorothiazide)
Amturnide and the ALTITUDE Clinical Trial
Concern over the safety of Amturnide is growing, following the premature termination of the ALTITUDE clinical study. Researchers were hoping that aliskiren would benefit people with high blood pressure and Type-2 diabetes who were at high risk of life-threatening cardiovascular events or renal impairments. Instead, when an independent data monitoring committee reviewed preliminary results, they found an increased risk of non-fatal stroke, renal complications, hyperkalemia (toxic levels of potassium in the bloodstream that can cause irregular heartbeat and sudden death), and low blood pressure. The clinical trial was immediately suspended on safety concerns.
In response, Novartis sent a letter to physicians announcing that it was ceasing all promotion of aliskiren-containing high blood pressure medications. In addition, they asked that physicians stop prescribing aliskiren with an ARB or an ACE inhibitor, and switch all patients taking Valturna to another medication. The problem is that 85% of people with high blood pressure take a combination of drugs to treat their condition, which nearly always includes an ARB or an ACE inhibitor. The results of the ALTITUDE study significantly reduce the number of people who could potentially use Amturnide safely.
Amturnide and other medications containing aliskiren have not been recalled. It is possible that there will be an Amturnide recall in the future. Thus far, no health authorities have mandated a recall, and Novartis has not volunteered to recall any of its medications containing aliskiren. If there is a recall, the most likely medication to be affected is Valturna. This is because Valturna contains a combination of aliskiren and a type of high blood pressure medication called an ARB. The ALTITUDE clinical study found that aliskiren plus an ARB carries a particularly high risk of side effects. Novartis has already asked physicians to stop prescribing Valturna, and recommended that current Valturna patients switch to another treatment.
After reviewing safety information, European health authorities required that Novartis update the safety labeling on Rasilez, the European brand-name version of Tekturna. The new label will warn prospective patients who have diabetes that they should not combine the medication with an ACE inhibitor or an ARB.
Amturnide and Stroke
The ALTITUDE clinical study was terminated because one side effect was a risk of stroke. Though, fortunately, the strokes in the study were non-fatal, all strokes have the potential to cause lifelong disability and death. Strokes are caused when there is a disruption to the blood supply to a part of the brain, which causes brain cells to die. The cause can be either a blood clot (ischemic stroke) or a broken blood vessel that causes bleeding in the brain (hemorrhagic stroke). In all types of stroke, brain damage is permanent. Severe brain damage can cause death.
Amturnide and Kidney Damage
Amturnide can cause damage to the kidneys, which increases the risk of a severe condition called hyperkalemia. It is thought that Amturnide interferes with the kidneys’ capacity to remove extra potassium in the bloodstream. Over time, potassium levels continue to rise, and can actually reach toxic, life-threatening levels. One of the biggest dangers with hyperkalemia is that it is not always treated or diagnosed right away, because the first symptoms are relatively mild (muscle weakness, heart palpitations, nausea, slow pulse, and fatigue). However, if untreated, 67% of people with hyperkalemia will die, usually by sudden, severe irregular heartbeat that causes death.