Novartis Updates Tekturna Safety Label

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Novartis Updates Tekturna Safety Label and withdraws ValturnaOverview: In compliance with the U.S. Food and Drug Administration (FDA), Novartis has updated the label on Tekturna/Rasilez (aliskiren) and other similar medications. The high blood pressure medication is now contraindicated in patients with diabetes and in patients with moderate renal impairment who are also taking angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs); medical professionals worry that the combination may increase the instances of renal impairment, hyperkalemia and hypotension.

 

 

  • According to new safety recommendations, Tekturna and Tekturna HCT should not be taken in combination with ACEIs or ARBs in patients with Type I or Type II diabetes
  • Tekturna should not be taken in combination with ACEIs or ARBs in patients with moderate to severe renal impairment (where [GFR] < 60mL/min)
  • The above combinations can increase the risk of kidney failure, hyperkalemia and hypotention
  • Previously, similar warnings were issued in the UK and Canada after the ALTITUDE studies were stopped

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

Latest Label Change

Last week, Novartis updated the safety information on medications containing aliskiren including:

  • Tekturna (aliskiren hemifumarate)
  • Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide)
  • Tekamlo (aliskiren hemifumarate and amlodipine besylate)
  • Amturnide (aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide)

The modified label is directed towards patients with diabetes, and to patients who have moderate to severe kidney failure, defined as having a glomerular filtration rate (GFR) less than 60 mL/min; the GFR indicates how quickly the kidneys are able to filter through the blood. In accordance with the FDA’s orders, the new labels states that these patients should not use Tekturna in combination with ACE inhibitors and ARBs, which are also used to treat high blood pressure-common ACE inhibitors and ARBs include Monopril and Diovan, respectively. In diabetics, the combination of these medications may increase the risk of hyperkalemia, hypotension and renal impairment.

Background: ALTITUDE Study Prompted Safety Reviews

Tekturna began to raise serious safety concerns last December, when the Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE) study was halted due to safety concerns. The study was conducted to see whether or not Tekturna was effective at lowering the risk of renal and cardiovascular events in patients with type II diabetes. The trials were stopped when an independent review committee found increased occurrences of non-fatal stroke, renal complications, hyperkalemia and hypotension.

The ALTITUDE findings led to regulatory action in both Europe and Canada. The European Medicines Agency (EMA) launched a review almost immediately, and released updated guidelines (similar to the FDA’s) in March. Health Canada reviewed and updated Tekturna’s label in January.