Our drug recall lawyers at Pintas & Mullins Law Firm are once again warning the public about the blood pressure drug Tekturna, which contains aliskiren and which, according to an Institute for Safe Medication Practices (ISMP) report, is associated with deadly side effects. Tekturna is an antihypertensive. The ISMP is a not-for-profit public safety group and their report stressed the increasing number of unfavorable event reports related to Tekturna and also Actos, Cymalta, Xarelto and other suspect drugs.
The ISMP’s QuarterWatch report is based on reports of adverse events submitted to the FDA. It highlights that the agency received at least 100 reports of complications associated with Tekturna in the first three months of 2012.
Angioedema, a medical state that causes rapid swelling, is the major and most severe side-effect. The condition usually affects the throat, lips, tongue or face and can be deadly if the swelling is enough to obstruct the airway.
The drug could be harmful in some patient groups when taken along with similar drugs such as valsartan, marketed under the trade name of Diovan. Reflecting on the drug’s safety problems, the ISMP questioned its clinical utilization considering that there were many other kinds of blood pressure treatments available.
Although Tekturna got the go-ahead in 2007 to be used as a hypertension drug, the drug’s manufacturer Novartis suffered a reversal in December 2011. The reversal was due to the lack of clinical studies assessing the drug’s effects on patients with type 2 diabetes and the chance of developing heart disease or kidney impairment. The studies, termed “ALTITUDE trials,” were halted owing to the possibility of severe complications.
The FDA updated Tekturna’s safety label early in 2012. The agency cautioned against using the hypertensive along with other hypertension medication, particularly ARBs or ACE inhibitors, in patients with kidney impairment or diabetes.
The QuarterWatch report also emphasized the increased danger of bladder cancer when taking Actos, a medication for Type 2 diabetes, for more than two years.
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The FDA safety announcement from April 2012 reveals that with ALTITUDE, the possibilities of hyperkalemia, hypotension and renal impairment in patients taking aliskiren along with ACEI or ARB increased in comparison to a section of patients taking placebo and ACEI or ARB.
The preliminary information from ALTITUDE also showed a small excess of stroke or death in the aliskiren group. At the time of the FDA’s safety announcement, the agency had not arrived at a conclusion regarding an actual connection between the drugs and stroke or death.
For the ALTITUDE study, more than 8,500 patients with renal disease and type 2 diabetes were randomly selected to receive placebo or aliskiren and ARB or ACE inhibitor.
Effective 20th of April 2012, the following recommendations were to be included in the drug labels of products containing aliskiren.
- A warning to refrain from utilization of aliskiren with ACEIs or ARBs in patients with moderate to serious renal impairment.
- A fresh contraindication against the utilization of aliskiren with ACEIs or ARBs in patients with diabetes owing to the possibility of hypotension, renal impairment and hyperkalemia.
Considering the dangerous complications associated with Tekturna, it is advisable to inform a healthcare professional if you are/were diagnosed with kidney problems or diabetes. Do not stop taking aliskiren without getting the opinion of your healthcare provider. Stopping the drug suddenly can lead to problems if the hypertension is not treated.
Inform your doctor if you are taking an ARB (angiotensin receptor blocker) or ACEI (angiotensin converting enzyme inhibitor).
If you experience any side effects from taking Tekturna, you can report them to the FDA MedWatch program. You also may be eligible to receive compensation with the assistance of a skilled drug recall attorney. Our attorneys will guide you through the legal process and help you secure the best possible settlement.