Researchers found that patients taking aliskiren, one of the ingredients in Amturnide, suffered a higher rate of non-fatal strokes, renal complications, hyperkalemia (toxic high levels of potassium), and low blood pressure. These severe side effects have the potential to cause lifelong medical problems, disability, or death.
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 one of a new line of medications containing aliskiren, a new drug created by the pharmaceutical company Novartis. Amturnide is a combination of three medications that can significantly lower high blood pressure, including:
- Aliskiren: The first FDA-approved “direct renin inhibitor” (DRI), which lowers blood pressure by inhibiting renin, a substance that normally causes blood vessels to constrict. Aliskiren is sold alone under the brand-name Tekturna.
- Amlopidine: A calcium-channel blocker, which relaxes smooth muscles. Aliskiren plus amlopidine is sold under the brand-name Tekamlo.
- Hydrochlorothiazide (HCTZ): A widely-used diuretic that treats high blood pressure by helping the body eliminate water and salt from the bloodstream, making it easier for the heart to pump blood
The FDA approved Amturnide in December 2010. It is not intended to be a first-line treatment. Instead, it is intended to be used by patients who did not benefit from either Tekturna or Tekamlo. Amturnide is more effective at reducing blood pressure than either of these medications.
High blood pressure, also known as “hypertension,” is a disorder in which the smooth muscles along the blood vessels are abnormally constricted, causing blood vessels to narrow and tighten. This makes it more difficult for the heart to pump blood through the body, and increases pressure. Though only 50% of Americans with high blood pressure control their disorder with a medication, untreated hypertension is associated with a higher risk of heart attack, stroke, and other deadly cardiovascular events.
Several drugs that contain aliskiren are manufactured by Novartis. The Clark Firm, LLP 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
The ALTITUDE clinical trial was intended to see whether people who had high blood pressure and Type-2 Diabetes would benefit from using aliskiren for at least 18-24 months. The patients were all at high risk of cardiovascular events and renal problems. They were split into one group taking aliskiren and one group taking a placebo. What the study found was that the group taking aliskiren had a higher risk of non-fatal stroke, renal problems, hyperkalemia (toxic levels of high potassium in the bloodstream), and low blood pressure. Based on these preliminary findings, Novartis immediately terminated the study.
As you may already be aware, Novartis has recently ceased all promotion of Amturnide and other aliskiren-containing hypertension medications. Novartis has also recommended that people currently taking an aliskiren-containing medication should not combine their treatment with an ACE inhibitor or an ARB. Unfortunately, more than 85% of people who take medication to treat hypertension use a combination of drugs. This therapy almost always includes an ACE inhibitor or an ARB, the most common and widely-used medications to treat high blood pressure. This means that very few people can use Amturnide safely.
Novartis has not yet issued an Amturnide recall, and the drug remains available for U.S. consumers. However, it is possible that there will be a recall of Amturnide in the future. So far, only European health authorities have mandated that Novartis change the safety information on Rasilez, to warn that patients with diabetes should not use Rasilez with an ARB or ACE inhibitor. Rasilez is the European version of Tekturna; the primary ingredient in both medications is aliskiren. Novartis announced that the company is currently in talks with global health authorities regarding the future of Amturnide and other hypertension medications containing aliskiren.
Amturnide and Stroke
The ALTITUDE study was terminated because researchers found a higher risk of stroke. The good news is, the strokes in the study were non-fatal. However, even non-fatal strokes have the potential to cause lifelong disability. This is because strokes can cause severe, permanent brain damage. The types of disability depend on what part of the brain was damaged during the stroke. There are actually two different types of stroke: hemorrhagic stroke (bleeding in the brain) and ischemic stroke (blood clot in the brain). In all types of stroke, part of the brain is deprived of oxygen-rich blood, causing brain cells to die. There is no way to cure brain damage.
Amturnide and Kidney Damage
Amturnide has been linked to kidney damage, which reduces the body’s ability to remove certain substances, such as potassium, from the bloodstream. In a condition called hyperkalemia, potassium levels get extremely high and become toxic. Because hyperkalemia is difficult to diagnose, around 67% of people with this condition will die. The first symptoms are mild: nausea, muscle weakness, fatigue, heart palpitations, and slow pulse. However, if potassium levels continue to rise, a person can suffer severe irregular heartbeat that can cause sudden death.