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High Blood Pressure Drug, Tekturna, Under Investigation

Filed January 29th, 2013 admin

Novartis is under investigation for its marketing of Tekturna (aliskiren), a high blood pressure medication, Bloomberg News reports. The report has caused national law firm, Parker Waichman, to weigh in.

According to Bloomberg News, last year a U.S. unit of the company received a subpoena from federal prosecutors in Louisville, Kentucky requesting documents on sales practices; this includes payments to healthcare providers for the drug and other medicinal products.

Tekturna, which was approved in the U.S. in 2007, first raised safety concerns when Novartis halted clinical trials of the drug in December 2011. The ALTITUDE trials were conducted to see whether or not Tekturna could prevent cardiovascular and kidney problems in patients with diabetes. Novartis stopped the study after a review committee discovered that patients taking Tekturna had a higher rate of complications, including: non-fatal stroke, kidney problems, complications, high potassium and low blood pressure.

Late last year, the Institute for Safe Medication Practices (ISMP) released a report focused on the increasing number of adverse events associated with four “suspect” drugs, including Tekturna. The ISMP used the FDA’s adverse event report database and found that in the first quarter of 2012 alone there were 100 reports of complications associated with Tekturna. The most prominent side effect was angioedema, a rapid swelling that typically affects the face, tongue, lips or throat. ISMP’s report said that the swelling can happen at any time during treatment and can become life threatening if the airway is obstructed.

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