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U.K. Regulator Issues Drug Safety Update For Rasilez

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British regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), just issued a Drug Safety Update for Rasilez, sold as Tekturna in the United States

Using aliskiren (Rasilez or Tekturna) in combination with two types of heart drugs—angiotensin-converting enzyme (ACE) inhibitors and Angiotensin II receptor blockers (ARB)—has been linked to serious and adverse cardiovascular and renal reactions in a large clinical trial known as ALTITUDE, said NewsInferno. According to the MHRA, this combination is now contraindicated in Type 1 and Type 2 diabetics and for patients with kidney impairment. Also, said the MHRA, the aliskiren combination with an ACE inhibitor or an ARB, is not recommended for patients with severe renal impairment.

The ALTITUDE study (ALiskiren Trial In Type 2 diabetes Using cardiovascular and renal Disease Endpoints) was a four-year, multi-center, randomized, placebo-controlled trial that was created to review aliskiren’s effect on the potential for cardiovascular and kidney events in high-risk diabetic patients, NewsInferno explained. Participants were randomized to receive either aliskiren 300 mg daily or placebo.

All patients recruited into the trial were already taking either an ACE inhibitor or ARB, so those patients randomized to the aliskiren group received two agents that block the RAAS (dual RAAS block). In total, over 8600 patients were recruited into the study.

Approved as Rasilez and Tekturna in 2007, aliskiren, manufactured by Novartis, was hoped to be the drug maker’s next blockbuster. Aliskiren was approved for the treatment of hypertension (high blood pressure) either as single (monotherapy) or combination therapy with other drugs, noted NewsInferno and works by inhibiting the renin-angiotensin-aldosterone system (RAAS) through its direct effect on renin, which blocks the conversion of angiotensinogen to angiotensin I.

In December, Novartis announced ALTITUDE had to be ceased after an independent review committee saw increased incidences of adverse events in patients receiving Rasilez/Tekturna in addition to standard care, said NewsInferno. The committee also saw an increased incidence of serious side effects in the high risk population after a period of 18-24 months. These side effects included non-fatal stroke, kidney complications, hyperkalemia (high potassium), and hypotension (low blood pressure).

As a precautionary measure, Novartis stopped promotion of the drug and combination products containing aliskiren in combination with an ACE inhibitor or ARB in December. In January, Novartis agreed to a request from European regulators to add new safety warnings to the labels of aliskiren products concerning the ALTITUDE’s trial’s findings. The drug maker also wrote to physicians worldwide recommending that Type 2 diabetes patients should not be treated with aliskiren, or combination products containing aliskiren, also receiving an ACE inhibitor or ARB, said the MHRA.

The MHRA also stated that the combination is not recommended in other patients and that any use of aliskiren—either alone or in combination with other drugs—is not longer recommended for any patient suffering with severe kidney impairment.

U.K. prescribers have been advised to review, at a routine appointment, the treatment of patients prescribed aliskiren in combination with an ACE inhibitor or an ARB, said NewsInferno. For those patients taking an ACE inhibitor or an ARB, healthcare professionals should stop aliskiren, not initiating new treatment in diabetics or kidney patients. Kidney function and glucose tolerance should be monitored at appropriate intervals In all patients in which aliskiren treatment is continued or initiated, said the MHRA.

Tekturna Information:

Aliskarin is sold alone and in the following combination products:

Amturnide (containing Amlodipine, Hydrochlorothiazide, and Aliskiren)
Tekamlo 150/10 (containing Amlodipine and Aliskiren)
Tekamlo 150/5 (containing Amlodipine and Aliskiren)
Tekamlo 300/10 (containing Amlodipine and Aliskiren)
Tekamlo 300/5 (containing Amlodipine and Aliskiren)
Tekturna HCT 150/12.5 (containing Hydrochlorothiazide and Aliskiren)
Tekturna HCT 150/25 (containing Hydrochlorothiazide and Aliskiren)
Tekturna HCT 300/12.5 (containing Hydrochlorothiazide and Aliskiren)
Tekturna HCT 300/25 (containing Hydrochlorothiazide and Aliskiren)
Valturna (containing Aliskiren and valsartan)

Possible Tekturna side effect include:

  • Strokes (a/k/a cerebrovascular accident (CVA) – rapid loss of brain function(s) due to disturbance in the blood supply to the brain i.e. bleed)
  • Heart attacks
  • Acute rental failure and other rental complications (renal = kidney)
  • Hyperkalemia (kidneys not functioning adequately)
  • Hypotension (abnormally low blood pressure)
  • Syncope (loss of consciousness)

Tekturna and other aliskiren products are contraindicated in:

  • Diabetic patients (type I & type II)
  • Non-diabetic patients whose Glomerular Filtration Rate (GFR) is <60ml (GFR tells how much kidney function you have. It may be estimated from your blood level of creatinine
  • Patients taking an ACE inhibitor (Angiotensin-Converting Enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik)
  • Patient taking an ARB (Angiotensin Receptor Blockers (primarily used for the treatment of hypertension where the patient is intolerant of ACE inhibitors)
  • Patient has severe renal impairment
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