Novartis is looking at big trouble over the side effects caused by Tekturna (Aliskiren), a blood pressure drug sold by Novartis, after Tekturna's clinical trials were canceled by Novartis due to a high number of strokes and kidney problems among diabetic test subjects. Tekturna HCT, Valturna, TekAmlo and Amturnide are all variations of Teckturna (Aliskiren).
During the clinical trials, Novartis was testing Tekturna to see if it could be useful in the treatment of hypertension by diabetics. The results were disastrous. Rather than helping those who ingested Tekturna, Novartis that Tekturna may actually increase the risk of non-fatal strokes, kidney problems and other health risks.
As a result of the Tekturna clinical trial findings, a safety review of the potential Tekturna problems was launched this week in Canada, where the medication is sold under the brand name Resilez.
Here's where Novartis went wrong. Long before testing the safety and efficacy of Tekturna on diabetic patients, Novartis engaged in extraordinary reckless behavior --all in the name of increasing its profits. Among other things, Novartis was instructing its sales representatives to engage in "off-label marketing" of Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide for use in the diabetic patient population while claiming it had "protective effects" on these patients even though it was not specifically indicated for use in diabetic patients and actually caused serious adverse health effects.
Novartis announced the cancellation of the clinical trials via a December 20, 2011 press release. The trial, which was known as ALTITUDE, involved 8,609 patients from 36 countries. The ALTITUDE trial was a randomized, double-blind, placebo-controlled study of the drug's use in patients with diabetes and kidney problems. See http://www.reuters.com/article/2011/12/20/idUS48151+20-Dec-2011+HUG20111220
The ALTITUDE study found an increase in Tekturna side effects after 18-24 months. These dangerous side effects included not only strokes and renal complications, but also caused hypotension (low blood pressure) and hyperkalemia (high potassium), both of which can cause dangerous circulatory problems, such as a low pulse and heart rate. See http://www.reuters.com/article/2011/12/20/idUS48151+20-Dec-2011+HUG20111220
The ALTITUDE trial involved the use of Tekturna along with agiontensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). As a result, Novartis says it will cease promoting the use of Tekturna in combination with those drugs in any patients. See http://www.reuters.com/article/2011/12/20/idUS48151+20-Dec-2011+HUG20111220
The ALTITUDE trials were cancelled after an independent Data Monitoring Committee (DMC), which was overseeing the clinical trial, became alarmed by the high rate of Tekturna health risks among the ALTITUDE trial subjects and recommended that Novartis immediately stop the study because of the dangerous side effects and the risk to the study's participants. See http://www.rttnews.com/1784537/novartis-reveals-termination-of-altitude-trial-with-rasilez-tekturna.aspx
Tekturna (Aliskiren) is an anti-hypertensive (blood pressure lowering) medication. Novartis claims it works by decreasing substances in the body that narrow blood vessels and raise blood pressure. Tekturna was launched by Novartis in April 2007. See http://www.drugs.com/tekturna-hct.html
Tekturna is indicated by the FDA for the treatment of hypertension, to lower blood pressure. See http://www.drugs.com/tekturna-hct.html
TekturnaHCT contains a combination of hydrochlorothiazide and Aliskiren. Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention. TekturnaHCT is indicated for the treatment of hypertension, to lower blood pressure in: (a) patients not adequately controlled with monotherapy; or (b) as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. See http://www.drugs.com/tekturna-hct.html
Valturna is a combination of aliskiren, a renin inhibitor, and valsartan, an angiotensin II receptor blocker (ARB). Valturna is indicated for the treatment of hypertension, to lower blood pressure: (a) in patients not adequately controlled with monotherapy; (b) May be substituted for titrated components; (c) as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. Novartis launched Valturna in January 2010. See http://www.drugs.com/pro/valturna.html
TekAmlo contains a combination of Aliskiren, a renin inhibitor, and amlodipine, a dihydropyridine calcium channel blocker. Novartis launched TekAmlo in 2011. Amlodipine relaxes (widens) blood vessels and improves blood flow. TekAmlo is indicated for the treatment of hypertension, to lower blood pressure: (a) as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals; (b) in patients not adequately controlled with monotherapy; (c) as a substitute for its titrated components. See http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=28627
Amturnide is a combination of Aliskiren, amlodipine besylate (a dihydropyridine calcium channel blocker) and hydrochlorothiazide (HCTZ) (a thiazide diuretic). Amlodipine is in a group of drugs called calcium channel blockers. Amlodipine besylate relaxes (widens) blood vessels and improves blood flow. HCTZ is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention. Amturnide is indicated for the treatment of hypertension, to lower blood pressure, and is not indicated for initial therapy. See http://dailymed.nlm.nih.gov/dailymed/mobile/drugInfo.cfm?id=56247
Novartis' Off-label Promotion of Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide
According to messages from sales representatives on CafePharma, Novartis engaged in an off-label marketing campaign to promote Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide specifically for use in the diabetic patient population, a use for which each of the drugs is not indicated. See http://www.cafepharma.com/boards/showthread.php?t=480316 See also http://www.cafepharma.com/boards/showthread.php?t=482965 See also http://www.cafepharma.com/boards/showthread.php?t=486183
In fact, sales representatives were trained to illegally used an unbranded sales aid (approved for a disease state, not a drug) that showed the effect of Renin in a rat kidney in order to sell Tekturna and Valturna to the diabetic patient population. This sales aid was used by Novartis to convince prescribers that these drugs had positive health effects for the diabetic patient population. The sales aid was known as the "flash card campaign." http://www.cafepharma.com/boards/showthread.php?t=486183 See also http://www.cafepharma.com/boards/showthread.php?t=486127
According to some, these drugs can cause more harm than good. Moreover, Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide carry serious cardiovascular and renal side-effects when used in combination with an ACE or ARB, a use which is most common.
On December 20, 2011, Novartis temporarily suspended the promotion of Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide for use in combination with an ACE inhibitor or ARB. See http://www.reuters.com/article/2011/12/20/idUS48151+20-Dec-2011+HUG20111220
What is Next?
Novartis has not yet released data from the study, but has informed all of the clinical trial's investigators to remove Tekturna products from their patients' treatment regimen. The company is also in consultations with governments worldwide about Tekturna health risks.
JONES WARD PLC partner Larry Jones says, "Given the level of misconduct associated with the marketing and off-label promotion of this drug, combined with the disastrous side effects, it is likely that Novartis will soon be taken to task for putting the desire for profits over the safety of consumers. We intend to be intimately involved with holding Novartis responsible for the lives it has damaged."
For another great article on the topic, look at Dr. Shezad Malik's blog http://fortworth.injuryboard.com/fda-and-prescription-drugs/novartis-tekturna-problems-study-cancellation.aspx?googleid=297374
For more information about Tekturna lawsuits, feel free to contact The Recall Lawyers or dangerous drug attorney Larry Jones by clicking here: larry@jonesward.com.
