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Blood Pressure Medication Tekturna Linked to Potentially Deadly Complications, Says Public Safety Group

Nov 1, 2012

Parker Waichman LLP is reporting that Tekturna, a drug used to treat hypertension, is associated with potentially fatal side effects. According to a report by the Institute for Safe Medication Practices (ISMP), the U.S. Food and Drug Administration (FDA) received at least 100 adverse event reports linked to the drug; among them were reports of angioedema, a rapid swelling that can lead to airway obstruction.

Parker Waichman, a national law firm dedicated to protecting the rights of victims injured by defective drugs, is notifying the public about a recent report by the Institute for Safe Medication Practices (ISMP), a non-profit public safety group. The report emphasized the increasing number of adverse event reports associated with Tekturna and other "suspect drugs," including Actos, Xarelto and Cymbalta.

The ISMP's QuarterWatch report, which is based on adverse event reports submitted to the U.S. Food and Drug Administration (FDA), found that the agency had received 100 reports of complications linked to Tekturna during the first quarter of 2012. The most serious and prominent side effect was angioedema, a medical condition that causes rapid swelling. Typically, the condition affects the face, tongue lips or throat; this "can occur at any time during treatment and may be life threatening if the airway is obstructed," the ISMP states.

The report also found that Tekturna "might be harmful in at least some patient groups" when taken with similar drugs that involve the renin-angiotensin system, including valsartan, sold under the brand name Diovan. In considering these safety issues, the ISMP questioned the clinical use of Tekturna given the fact that there are many different types of blood pressure treatments available.

The QuarterWatch report also highlighted the increased risk of bladder cancer when taking the Type 2 diabetes medication Actos for more than two years. Xarelto, a warfarin replacement medication approved to decrease the risk of blood clots after knee and hip replacement surgery, was linked to the greatest number of adverse event reports, including severe blood clots in younger patients. According to the ISMP, the FDA also received reports of suicidal thoughts, nausea, blackouts and tremors associated with the withdrawal of Cymbalta, an antidepressant.

Tekturna was approved in 2007 to treat patients who suffer from high blood pressure, or hypertension. The medication, which is also sold under the brand name Rasilez outside of the United States, works by interfering with the body's renin-angiotensin system, an enzymatic pathway that controls blood pressure.

Last December, Novartis suffered a setback with Tekturna when clinical studies evaluating its effects on patients with type 2 diabetes at risk for kidney impairment or heart disease were stopped due to the presence of serious side effects. The studies, called the ALTITUDE trials, were halted due to complications including:

  • Non-fatal stroke
  • Renal complications
  • Hyperkalemia (high potassium)
  • Hypotension (low blood pressure).

In April, the FDA updated the safety label on Tekturna. The agency warned against using the drug with other hypertension medications, specifically ACE inhibitors or ARBs, in patients with diabetes or kidney impairment.

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