New York, New York (PRWEB) April 20, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the legal rights of people injured by defective drugs, is warning of potentially serious Tekturna (Aliskiren) and Valturna side effects, including non-fatal strokes, heart attacks and kidney failure, in patients with diabetes or kidney problems. Novartis has announced that it will be modifying the labels for Tekturna and Aliskiren with new warnings regarding these risks. The company also announced that it will cease marking Valturna, a single-pill combination of Aliskiren and the angiotensin receptor blockers (ARB), Valsartan, in the U.S. by July 20, 2012. [pharma.us.novartis.com/assets/pdf/Aliskiren%20FDA%20Update%20US%20Statement.pdf]
Approved in 2007, Tekturna is indicated for the treatment hypertension (high blood pressure) either as monotherapy or in combination with another medication. According to Novartis, the modified Tekturna labels will warn against:
- The combined use of Aliskiren-based products with ACE Inhibitors and ARBs patients with diabetes.
- A warning against the use of Aliskiren-based products in patients with moderate renal (kidney) impairment (eGFR < 60 ml/min) who are also taking an ACE inhibitor or an ARB.
The labels for Tekturna HCT (Aliskiren and hydrochlorothiazide), Tekamlo(TM) (Aliskiren and amlodipine) and Amturnide (Aliskiren, amlodipine and hydrochlorothiazide) will also be subject to these modifications, Novartis said.
Novartis said it will continue to make Valturna available in the U.S. until July 20, 2012. Patients taking Valturna are being advised discuss alternative therapies with their doctors prior to that date.
According to a statement from Novartis, the company is taking these actions at the request of the U.S. Food & Drug Administration (FDA), which has completed a preliminary review of its halted ALTITUDE study. The ALTITUDE clinical trial was designed to evaluate the effect of Aliskiren on the likelihood of cardiovascular and kidney events in high-risk diabetic patients. The more than 8,600 type-2 diabetes patients enrolled in ALTITUDE were treated with either Aliskiren or a placebo in combination with either an ARB or ACE Inhibitor. Novartis announced in December that ALTITUDE was being halted after an independent review committee noted higher adverse events in patients receiving Aliskiren in addition to standard of care in the trial. There was also an increased incidence after 18-24 months of serious side effects in the high risk population, including non-fatal stroke, kidney complications, hyperkalemia, and hypotension. [novartis.com/newsroom/media-releases/en/2011/1572562.shtml]
Parker Waichman LLLP offers free legal consultations to victims of Tekturna side effects. If you or a loved one suffered a stroke, heart attack, kidney problem or other side effect while taking Tekturna or Valturna, please contact their office by visiting the firm's Tekturna Injury page at http://www.yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
For more information regarding Tekturna or Valturna injury lawsuits and Parker Waichman LLP, please visit: http://www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Herbert Waichman, Partner