Tekturna Side Effects: Blood Pressure drug linked
to stroke & serious injuries
Tekturna (Aliskiren) is a blood pressure drug sold by Novartis. 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 extremely troubling. Rather than helping those who ingested Tekturna, Novartis found 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 in Canada, where the medication is sold under the brand name Resilez.
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. Novartis paid illegal kickbacks to health care professionals through mechanisms such as speaker programs, advisory boards, entertainment, travel and meals to induce them to prescribe Trileptal, as well as Diovan, Zelnorm, Sandostatin, Exforge and Tekturna. 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. In fact, 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.
The ALTITUDE study found an increase in Tekturna side effects after 18-24 months. These dangerous side effectsincluded 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.
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.
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.
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. Tekturna is indicated for the treatment of hypertension, to lower blood pressure.
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.
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.
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.
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.
Novartis' Off-label Promotion of Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide
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. Novartis' sales reps were instructed to sell these drugs specifically for use in diabetic patients; none of these drugs carry a special indication for use in the diabetic patient population.
Because Tekturna is the only drug on the market that is a Direct Renin Inhibitor, this allowed for Novartis to heavily promote the drug (or one of its combinations) for use in the diabetic patient.
Sales representatives voiced concerns about selling these drugs for uses for which they were not indicated. Company managers refused to budge.
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.
Novartis trained its sales representatives to make claims that Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide would significantly lower blood pressure, protect the heart, protect the kidneys and protect organs. Yet, such claims were unsupported by medical science and in fact, contrary to medical data that suggests that the drugs Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide cause an increase in cardiovascular risk, including stroke, renal complications, hyperkalemia and hypotension, especially in the diabetic patient population.
During the time that Novartis was actively engaging its sales representatives to use such tactics, it is believed by some that Novartis possessed and still possesses information that Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide causes serious health risks, some of which has been released via the ALTITUDE clinical trial.
According to some, Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide have minimal blood pressure lowering effects and are of little benefit to patients. To the contrary, 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.
But prior to its December 20th action, Novartis paid kickbacks in the form of speaker fees and "Lunch and Learns" in order to promote Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide to the diabetic patient population.
Indeed, Novartis paid physician speakers to hold "unbranded" speaker series supporting the Tekturna family of brands in order to promote Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide to the diabetic patient population.
Novartis even promoted Valturna to the diabetic patient population through use of $15 Vouchers that were used for insurance and cash pay patients.
Novartis also off-label promoted Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide to the diabetic patient population with product samples and vouchers to influence prescribers.
Additionally, Novartis off-label promoted Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide to the diabetic patient population during professional conventions.
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.
For another analysis on the topic, see at Dr. Shezad Malik's blog (here).
Experienced Drug Product Liability Lawyers Serving all of Tennessee
If you or a family member is suffering from a serious injury or health complication as the result of Tekturna you should speak with an experienced defective drug product attorney about your legal rights and options. You may have grounds to file a claim in pursuit of compensation for your current and future medical bills, pain and suffering, mental anguish, lost wages, and decreased quality of life. In the event that your loved one has died due to a drug error with Tekturna, you can speak with an attorney about filing a wrongful death or injury claim.