Tekturna (known scientifically as aliskiren hemifumarate) is a prescription drug intended to treat high blood pressure and hypertension. It is the first drug of its kind and produced by the Switzerland-based pharmaceutical giant Novartis AG. Tekturna is intended to inhibit the production of renin, which is produced in the kidneys, helping to regulate the body’s arterial pressure. The drug has been clinically proven to improve outcomes for patients facing complications related to elevated blood pressure and hypertension. It was extremely popular during the first nine months of 2011, bringing in almost $450 million in sales.
While effective, Tekturna has also been associated with a variety of serious side effects. Among these side effects are:
- Dizziness (related to hypertension and may include fainting)
- Swelling (including angiodema and affecting the mouth, throat or tongue and lips)
- Kidney Stones
- Hyperkalemia (associated with elevated potassium levels and includes muscle weakness, low heart rate, and various degrees of burning, tingling or pricking)
During clinical testing, two episodes of tonic-clonic seizures (previously known as grand mal seizures) were reported in two patients treated with aliskiren (the active ingredient in Tekturna). One of the patients had a preexisting cause for seizures and a negative electroencephalogram (EEG) and cerebral imaging following the seizures. The other patient’s EEG and imaging results, however, were not reported. Aliskiren was discontinued, and there was no rechallenge.
Less serious, but more common, side effects of Tekturna during testing included 2.3% of users experiencing diarrhea; 1.1% of users experiencing intense coughing; and, over 1% of users developing a rash.
A 2010 survey entitled the ALTITUDE study was designed to evaluate the effect of Tekturna and its active ingredient on the likelihood of cardiovascular and kidney events in high-risk diabetic patients. After a preliminary interim analyses, the doctors working on the study concluded that the patients were unlikely to benefit from Aliskiren. The ALTITUDE study also demonstrated an increased incidence over 18 to 24 months of serious side effects in the highest risk population, including non-fatal stroke, kidney complications, hyperkalemia, and hypotension.
In 2011, as a precautionary measure, Novartis began to place warning labels on the drug in the United States, Canada and Europe, urging health care providers to stop treating diabetic patients with Tekturna and to consider other, safer alternative treatments, as necessary. This was due to reports showing a high rate of adverse events. The FDA also issued a warning against the use of Tekturna when combined with other ACE Inhibitors and ARBs in patients with kidney impairment or diabetes. While the FDA has not officially linked these drugs to stroke and death, research is ongoing.
Novartis has 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 have unfortunately come too late.
Tekturna has now become the subject of many lawsuits naming Novartis as a defendant. Sheff Law is a Massachusetts law firm with the resources, experience, and national reputation to investigate injuries and deaths that may result from taking Tekturna. Patients across Massachusetts and America have been affected by the potential harmful consequences of using Tekturna. If you or a loved one has been injured or become ill as a result of taking Tekturna or another defective drug, contact an attorney at Sheff Law today by filling out a free consultation form, or call at (888) 423-4477 or 617-227-7000.
February 23rd, 2016 | Posted in Blog