Independent watchdog group, the Institute for Safe Medical Practices (ISMP) reports a 90 percent increase in significant adverse drug event reports received by the U.S. Food & Drug Administration (FDA) over the past four years.
Among these, are events associated with Novartis’ Tekturna (aliskiren). As we’ve explained, Novartis launched Tekturna in 2007 for the treatment of high blood pressure, conducting a number of trials to determine if Tekturna could protect vital organs when taken for longer periods.
ISMP explained that it observed a serious hypersensitivity reaction—angioedema, a sudden swelling that can impact the tongue, face, lips, or throat—that can take place at any time during treatment and could result in life-threatening problems if the patient’s airway is obstructed. Also, a combination medication involving aliskiren and valsartan, an angiotensin receptor blocker, was withdrawn when a clinical trial revealed that treating patients with two drugs that are active in “the renin-angiotensin pathway” could harm some patients. Novartis told ISMP it was investigating the angioedema issue.
The FDA received 57,393 reports meeting ISMP’s criteria for an adverse event, which was a 23.8 percent increase over the prior quarter, what ISMP described as “sustained and substantial growth” in adverse event reporting linked to new and existing medications. A 30.1 percent increase was seen in the same quarter of the prior year. Tekturna was among the top four medications in which adverse events were reported and was associated with 100 adverse event reports to the FDA in the first quarter, said Lawyers USA Online. ISMP’s report, Quarter Watch, relies on FDA data, said Lawyers USA Online.
We recently wrote that Tektuma was scheduled to undergo a Canadian Safety Review after Novartis halted a clinical study over unexpected adverse reactions. ” Tekturna is in a class of drugs known as direct rennin inhibitors, and is known generically as aliskiren, which is sold in Canada and elsewhere, under the brand name Rasilez.
When blood pressure increases to high levels, explained CBC News, the pressure forces the heart to work harder, increasing death risks from a number of causes, including heart disease and stroke. Tekturna is intended to reduce the body’s production of the enzyme renin, which has been shown to increase blood pressure.
Novartis, announced it was halting the multinational clinical trial created to determine if adding Tektuma to tradition treatments in people diagnosed with Type 2 diabetes and kidney impairment could lower risks for cardiac and kidney problems, explained CBC News. Novartis also said it will stop marketing aliskiren for use with ACE-inhibitors and angiotensin receptor blockers until regulators determine if the aliskiren’s marketing license needs to be amended.
The ceased trial—known as ALTITUDE—involved 8,606 Type 2 diabetes patients at increased risk for heart or kidney failure and who took Tekturna in addition to receiving traditional heart treatment. Participants came from 36 countries. The committee overseeing the study discovered greater-than-expected, unwanted adverse events once the drug was added to traditional treatments, including higher rates of nonfatal stroke, renal complications, and other problems. The committee also found the drug failed to prove more effective than a placebo.
Just prior, we wrote that Europe’s key drug regulator, the European Medicines Agency (EMA) announced it was initiating a review of aliskiren’s benefits and risks and had advised doctors to stop prescribing the medication to diabetic patients also taking older generation hypertension medications (ACE inhibitors, angiotensin receptor blockers).
We also previously wrote about a study published in the American Journal of Hypertension in 2007 that called into question the drug’s efficacy. The study was conducted at Weill Medical College of Cornell University in New York.