Analysis of adverse event reports questions benefit of blood pressure drug Tekturna

A recent analysis of adverse health events linked to certain prescription drugs identified 100 incidents linked to the blood pressure medication Tekturna in just the first part of this year.

The Institute for Safe Medication Practices (ISMP) combed a database compiled by the Food and Drug Administration that tracks adverse events linked to prescription drug side effects. Tekturna was identified as one of several “suspect drugs” because 100 adverse event reports were filed against it in just the first quarter of 2012.

The national law firm of Parker Waichman LLP has highlighted the main notes from the ISMP report. The firm actively represents victims of Tekturna side effects, a growing class of people since the FDA issued a warning earlier this year and updated the safety labels on the drug to indicate the high risk of side effects when the drug was taken in conjunction with other blood pressure medicines or by patients suffering from type 2 diabetes or impaired kidneys.

In its regular ISMP QuarterWatch report, the public health advocacy group noted that of the 100 adverse event reports linked to the use of Tekturna, the most commonly reported side effect was angioedema. Angioedema is marked by excessive and rapid swelling, mostly in the face, tongue, lips, and throat. If this condition affects or obstructs a person’s airway, they could face life-threatening consequences if emergency treatment is not delivered quickly. 

The report flatly questions the clinical use of Tekturna. ISMP also notes that the drug “might be harmful in at least some patient groups.” One of those groups is patients taking drugs that interact with the renin-angiotensin system, like valsartan which is marketed under the brand name Diovan. Since there are so many other blood pressure treatments on the market available to patients, ISMP wonders if Tekturna has a place among them.

Tekturna is manufactured and marketed by the pharmaceutical firm Novartis. The drug is designed to treat patients suffering from hypertension, high blood pressure, by interfering with the body’s renin-angiotensin system, an enzymatic pathway that controls blood pressure, according to the firm’s information.

In addition to the risks noted in the ISMP report, Tekturna has also been linked to other dangerous side effects and a clinical trial of the drug, named ALTITUDE, that tested its impact on patients suffering from type 2 diabetes who were at greater risk of kidney impairment and heart disease was stopped when too many participants experienced serious side effects like a non-fatal stroke, kidney problems, dangerously high levels of potassium (known as hyperkalemia), and hypotension (low blood pressure).

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