FDA Received 100 Adverse Event Reports Linked to Tekturna®, According to ISMP


FDA Received 100 Adverse Event Reports Linked to Tekturna®, According to ISMPOverview: The U.S. Food and Drug Administration (FDA) has received a substantial number of adverse event reports associated with Tekturna, according to a report by the The Institute for Safe Medication Practices (ISMP). The non-profit consumer safety group focused on the serious side effects associated with several drugs, including Tekturna, in their latest QuarterWatch report.

  • According to the ISMP’s QuarterWatch report for first quarter 2012, the FDA received 100 adverse event reports associated with Tekturna
  • The most prominent side effect was angioedema, a reaction that can lead to swelling and airway blockage
  • Tekturna is a high blood pressure medication that has been linked to serious side effects when used in certain patient populations

Product: Tekturna® (aliskiren), also sold under the brand name Rasilez outside the US

Manufacturer: Novartis

Side Effects & Complications

  • Strokes
  • Heart attacks
  • Acute renal failure
  • Renal complications
  • Hyperkalemia (high levels of potassium)
  • Hypotension (low blood pressure)
  • Syncope

ISMP Report

The ISMP’s most recent QuarterWatch Report focused on four “suspect drugs that resulted in greatly increased numbers of reports. In addition to Tekturna, the report discussed serious adverse events associated with Actos, Cymbalta and Xarelto. According to the report, the FDA received over 100 adverse event reports related to the hypertension drug in the first quarter of 2012. The most prevalent event reported was angioedema, rapid swelling that can affect the face, tongue, lips or throat. The ISMP states that angioedema “can occur at any time during treatment and may be life threatening if the airway is obstructed.” The report also noted that the medication may lead to serious complications when taking in combination with other similar drugs.

The report also found that Actos, a type 2 diabetes medication, was associated with an increased risk of bladder cancer after using the drug for two years. Xarelto, a warfarin replacement drug like Pradaxa, was linked to the largest number of adverse event reports and was associated with severe blood clots in younger patients while withdrawal of the antidepressant Cymbalta was linked to suicidal thoughts, blackouts, tremors and nausea.

The ISMP concluded that for Tekturna “the angioedema signal combined with issues about the safety of the drug when used in combination with other antihypertensives that act on the renin-angiotensin system raises questions about the clinical utility of this drug for an indication with many alternatives.”


Tekturna was approved in March 2007 to treat patients with high blood pressure hypertension. At the time, the FDA approved for the drug to be alone or in combination with other high blood pressure medications.

The hypertension medication raised safety concerns last year, when clinical trials were stopped due to the presence of serious side effects. The so-called ALTITUDE trials were intended to study the effects of Tekturna in patients with type 2 diabetes or kidney impairment, but studies were halted after a review committee observed elevated rates of non-fatal stroke, renal complications, hyperkalemia (high potassium) and hypotension (low blood pressure).

In April, the FDA updated the safety label on Tekturna, contraindicating the drug in patients who have diabetes or moderate kidney impairment also taking hypertension drugs including ACE inhibitors or ARBs.