Our drug recall attorneys at Pintas & Mullins Law Firm are warning of new research that shows the blood pressure drug Tekturna (Aliskiren) may increase the risk of stroke or serious heart and kidney problems. This is a major setback for the hypertension drug that could potentially lead to a recall, according to recent reports by Bloomberg News.
Tekturna is sold by Novartis and was originally approved in 2007 to lower blood pressure. Tekturna was the 16th best selling drug in 2010 for drug maker Novartis, who recently conducted a study to determine whether the medication could help patients suffering from type 2 diabetes and renal impairment. The ALTITUDE study evaluated the effectiveness of Tekturna in reducing or delaying heart and kidney events, along with the drug’s ability to resuscitate sudden death or heart attack patients. Shockingly, the clinical trial came to a halt in January of 2012 when serious safety issues were revealed. Instead of benefiting from the medication, Tekturna study participants actually suffered an increased rate of hypertension, stroke, and renal complications.
As a precautionary measure, Novartis issued a drug warning to healthcare professionals, urging them to stop treating diabetic patients with Tekturna and to consider other, safer alternative treatments as necessary. The drug maker also pledged to stop promoting Tekturna for use in combination with other drugs such as ACE-inhibitors until federal regulators determine whether further changes need to be made. However, for many patients who already suffered serious side effects, these warnings came too late.
The large number of adverse health events recently exposed through clinical trials will likely hurt Novartis financially. Tekturna brought in close to $450 million in sales during the first nine months of 2011, and sales are expected to plummet now that the company has stopped advertising the dangerous drug. Over 1,000 sales jobs could be lost as a direct result of the clinical findings. Analysts suspect that the drug may eventually be sold to another company or completely removed from the market.
Even more concerning to our defective drug lawyers is the harm that many patients have already suffered or the potential harm that they may suffer in the future as a result of using the medication. We are aware that Novartis engaged in off-label marketing, recklessly promoting the use of Tekturna for diabetes patients. In addition to a lack of evidence supporting any positive health benefits for the diabetic population, research now shows that these patients may be seriously harmed by use of the drug.
Drug manufacturers owe a legal duty to patients to conduct appropriate tests for the drugs that they sell. Manufacturers are also required to provide adequate warnings to doctors and patients. When a patient is seriously harmed by a defective drug such as Tekturna, legal recourse may be available. An experienced drug recall lawyer can help protect your legal rights and aggressively pursue a cause of action against the drug manufacturer. Compensation may be available for pain and suffering, lost wages, and medical expenses tied to use of the drug.
It is clear to our drug recall attorneys that Novartis recklessly marketed and engaged in off-label promotions of a dangerous drug that resulted in devastating side effects for patients. A Tekturna lawsuit can help individuals recover for the injuries that they suffered, and hold the drug maker legally responsible for the harm that they caused. Diabetes patients who used this medication should be aware of dangerous side effects, including kidney and heart damage, hypotension and hyperkalemia, and stroke. If you or a loved one experience any of these symptoms, it is important to contact a drug recall attorney today to protect your rights.