Valturna, manufactured and distributed by Novartis Pharmaceutical Corporation, is a high blood pressure medication that combines two powerful drugs into one tablet. Aliskerin (Tekturna) and valsartan are both popular blood pressure drugs developed by Novartis however the combination of the two has posed serious health risks for users. Complications due to this medication have patients filing Valturna lawsuits and seeking compensation from the pharmaceutical company.
Valturna has been shown to have increased risks of stroke, kidney impairment, hyperkalemia and renal complications. Studies show that this increased risk is largely due to the aliskerin (Tekturna) component of the medication.
ALTITUDE Clinical Trials
Novartis began a clinical trial to test the safety of Tekturna for use in diabetics and patients with kidney or renal impairments. After noticing a high increase in adverse effects such as stoke, renal problems and others, Novartis decided to discontinue the trials. Though Tekturna alone remains on the market, the FDA contraindicated the use of this medication for patients with diabetes that are currently taking angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs). The combined use of these products greatly increases a patient’s risk of adverse effects. Tekturna is still approved for use by appropriate patients however all are warned of the potential dangers of kidney and renal complications.
Once the trials were discontinued, Novartis decided to make a voluntary recall on Valturna since half of the medication was not safe for users. On April 20, 2012, Novartis announced that they would be pulling Valturna from the shelves and that it would no longer be produced for distribution on the U.S. market. By July of that year, Valturna was no longer available.
Hundreds of users suffered severe and harmful side effects from using Valturna before it was removed from the market. Tekturna users are still noticing adverse effects from the medication and are encouraged to seek alternative options for medication.
Complications from Valturna include, but are not limited to, kidney problems, strokes, hyperkalemia, hypotension and renal complications. Kidney problems and stroke cause permanent damage and can leave patients troubled even after drug use has been discontinued.
Valturna Kidney Failure
In September 2009, Valturna (aliskiren/ valsartan) was approved by the United States Food and Drug Administration (FDA) to regulate blood pressure. The single pill contained two blood pressure drugs, aliskiren and valsartan. Novartis Pharmaceuticals Corporation, the manufacturer of Valturna marketed the drug as more effective than aliskiren or valsartan alone. However, a study by the FDA in 2011 showed that use of Valturna could lead to increased risk of kidney failure.
What is Kidney Failure?
Renal (kidney) failure is the inability of the kidneys to excrete wastes. The kidneys job is to help maintain the electrolyte balance in the body, control blood pressure and stimulate the production of red blood cells. Without the function of the kidneys, the body can fill with extra water and waste products. Kidney failure can lead to the need for Dialysis or Transplantation.
Side Effects of Valturna
- Kidney Problems/failure
- High potassium
- Low blood pressure
- Renal complications
- Slow heart rate
- Weak pulse
Kidney Damage Symptoms
Valturna has been linked to kidney damage. The FDA urges patients with diabetes or renal impairments to avoid taking Valturna. Signs of Valturna induced kidney damage include:
- Inability to excrete potassium
- Rising potassium levels in the serum
- Fatal heart rhythm
- Ventricular tachycardia/ fibrillation
- Rising urea levels in the blood
- Inflammation of the heart lining
- Decreased muscle function
FDA Warnings/ Recall of Valturna
The FDA issued a warning to healthcare professionals in April 2012. The warning stated that the blood pressure drug Valturna should not be prescribed to patients with any form of diabetes or kidney impairment. According to reports Novartis marketed Valturna in an off-label use which was not approved by the FDA. In July 2012, Novartis Pharmaceutical Corporation recalled Valturna (aliskiren/valsartan) from the U.S market.
Patients have filed class action lawsuits against Novartis seeking compensation for their injuries as well as medical costs and recovery treatments. Patients with any history of renal complications, diabetes or kidney problems should notify their physician before beginning Tekturna. If you have suffered adverse effects while using Valturna, you may be eligible for compensation. Contact an experienced attorney to review your options and see if you qualify.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.