Tekturna®, TekturnaHCT®, Valturna®, Tekamlo®, Amturnide® and all Aliskiren Based Products Alert
Please Note: The Willis Law Firm, is no longer accepting Tekturna claims. If you feel that you may have a potential case, we urge you to locate another law firm adequately suited to handle your claim. Do not wait, as filing deadlines in some states are as short as One Year form the date of the injury in question. We urge you to speak to other lawyers as soon as possible.
On Decemeber 20, 2011 Novartis announced that the above drugs may cause serious and potentially life threatening side effects particularly for patients with Type 2 diabetes when taken with ACE & ARB drugs, including stroke, kidney damage, high potassium, low blood pressure and possible death. (See below)
Novartis has suspended promotion of Tekturna®, TekturnaHCT®, Valturna®, Tekamlo®, Amturnide®, Aliskiren® after terminating a study in patients with Type 2 diabetes and renal impairment who are also at high risk of cardiovascular and renal events after researchers saw an increased number of adverse events including non-fatal stroke, kidney complications, hyperkalemia and hypotension. An increased number of adverse events potentially caused by the drugs were found in a drug trial that was terminated according to Novartis and other sources on December 20, 2011. These adverse events increased when the drugs were given in combination with the heart/cardiovascular treatment ACE (angiotensin converting enzyme) and ARB (angiotensin receptor blocker) drugs. Patients with Type 2 diabetes are particularly at risk. Variations of the drug in combination with others may include HCT (hydrochlorothiazide) valsartan and/or amlodipine.
Potential side effects include:
NOTE: Novartis indicates that patients should not cease taking these drugs without consulting with their health care professional. If any drug reaction, side effect or injury occurs, seek medical treatment immediately. If you have any questions about these drugs and you medical care or possible health effects, then talk to you Doctor. If you are having serious or life threatening complications, call for medical attention immediately.
If you or a loved one have taken Tekturna®, TekturnaHCT®, Valturna®, Tekamlo®, or Amturnide® and suffered a stroke, heart attack, kidney damage, kidney failure, been diagnosed with high potassium or low blood pressure, then call our law firm to discuss a possible lawsuit, or claim for monetary damages for the injuries you have suffered. Talk to a Board Certified Personal Injury Trial Lawyer with over 25 years of personal injury trial experience. Call for a Free and Confidential Case Consultation regarding your injuries and losses.
Novartis announces termination of ALTITUDE study with Rasilez®/Tekturna® in high-risk patients with diabetes and renal impairment.
Basel, December 20, 2011 – Novartis announced that following the seventh interim review of data from the ALTITUDE study with Rasilez®/Tekturna® (aliskiren), a decision to terminate the trial has been taken on the recommendation of the independent Data Monitoring Committee (DMC) overseeing the trial. The DMC concluded that patients were unlikely to benefit from treatment added on top of standard anti-hypertensives, and identified higher adverse events in patients receiving Rasilez/Tekturna in addition to standard of care in the trial. Specifically, in the trial arm in which Rasilez/Tekturna was added to the standard of care there was an increased incidence after 18-24 months of non-fatal stroke, renal complications, hyperkalemia and hypotension in this high-risk study population. The placebo-controlled Phase III ALTITUDE study is the first trial to investigate Rasilez/Tekturna for more than one year in a specific population of patients with type 2 diabetes and renal impairment. These patients are known to be at high risk of cardiovascular and renal events. In the study, Rasilez/Tekturna was given in addition to optimal cardiovascular treatment including an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). Novartis is in ongoing discussions with health authorities worldwide about the implications of the findings from ALTITUDE for patients. As a precautionary measure Novartis will cease promotion of Rasilez/Tekturna-based products for use in combination with an ACE-inhibitor or ARB.
“Patient safety is the highest priority for Novartis, and we are in a dialogue with health authorities worldwide,” said David Epstein, Division Head of Novartis Pharmaceuticals. Novartis is recommending that ALTITUDE investigators remove Rasilez/Tekturna-based products from their patients’ treatment regimen and review their high blood pressure medication. Novartis is also reviewing the findings with DMCs of other clinical studies involving Rasilez/Tekturna-based products and combination therapies. 2/3
Patients in ALTITUDE should contact their study site for guidance on medication and should not stop treatment until they have seen their physician in view of the importance of controlling high blood pressure. Any patients using Rasilez/Tekturna or other aliskiren combination products who may have questions about their medication should consult their healthcare provider. For more information visit www.novartis.com.
Total sales of Rasilez/Tekturna-based products for the first nine months of 2011 were USD 449 million (1% of Novartis Group sales) and are likely to be negatively impacted by the study results going forward. Product profitability in 2011 was negative. A further update of the actual financial implications will be communicated when the regulatory dialogue has been concluded.
Aliskiren was approved in 2007 in the EU and US under the brand-names Rasilez and Tekturna respectively, for the treatment of hypertension (high blood pressure) either as monotherapy or in combination with other medications. The efficacy and safety of Rasilez/Tekturna have been investigated in more than 57,000 patients who have been treated with this medicine in clinical studies.
Rasilez/Tekturna-based products include:
ALTITUDE was a multinational study in 8,606 patients from 36 countries evaluating the potential benefits of Rasilez/Tekturna to reduce the risk of cardiovascular and renal events in this patient population. ALTITUDE was the first randomized, double-blind, placebo-controlled study to investigate Rasilez/Tekturna for more than one year in a specific population of patients with type 2 diabetes and renal impairment. These patients are known to be at high risk of cardiovascular and renal events. In the study, Rasilez/Tekturna was given in addition to optimal cardiovascular treatment including an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).
Date: December 20, 2011 9:15:42 AM CST
Subject: Urgent message about Aliskiren Speaker Programs
Novartis Pharmaceuticals Corporation
Novartis is writing to inform you that as a precautionary measure, in the best interest of patients, we have temporarily ceased promotion of Tekturna and all aliskiren-based products for use in combination with an ACE or ARB. This includes ceasing promotion of Valturna.
We have subsequently suspended all branded and unbranded promotional educational programs supporting Tekturna, Tekturna HCT, Tekamlo, Amturnide and Valturna.
Healthcare professionals should not combine an Aliskiren containing product with an ACE or an ARB. Therefore healthcare professionals should switch patients who are on Tekturna or any aliskiren-based products, in combination with an ACE or an ARB, to an alternative anti-hypertension regimen. This includes switching all patients on Valturna to an alternative therapy. This change should take place as soon as medically feasible, consistent with patient safety and the prescribing physician’s clinical judgment.
These actions are being taken following an interim review of data from the ALTITUDE clinical trial. This was the first study to investigate Tekturna for more than one year in a specific population of patients with type 2 diabetes and renal impairment. In the study, Tekturna was given in addition to optimal cardiovascular treatment including an ACE inhibitor or ARB.
Novartis was informed that the independent Data Monitoring Committee (DMC) overseeing ALTITUDE had recommended stopping the trial because Tekturna was unlikely to show any benefit, and potential safety concerns had been identified in these high-risk patients. Specifically, Tekturna was associated with an increased risk of non-fatal stroke, renal complications, hyperkalemia, and hypotension.
In view of the unexpected study findings, a decision was taken to terminate the ALTITUDE study. Patient safety is the highest priority for Novartis and we are in dialogue with health authorities worldwide. We are now assessing the results of the ALTITUDE study and the potential implications for aliskiren-based products.
Head, Cardiovascular/Metabolism & Inflammation Medical Unit
Novartis Pharmaceuticals Corporation
If you or a loved one have taken Tekturna®, TekturnaHCT®, Valturna®, Tekamlo®, or Amturnide® and suffered a stroke, heart attack, kidney damage, kidney failure, been diagnosed with high potassium or low blood pressure, then call our law firm to discuss a possible lawsuit or claim for monetary damages for the injuries you have suffered. Talk to a Board Certified Personal Injury Trial Lawyer with over 25 years of personal injury trial experience. Call for a Free and Confidential Case Consultation regarding your injuries and losses.