Recall of another anti-hypertensive drug, Irbesartan!

Irbesartan recall after valsartan has created a panic in hypertensive patients. Irbesartan is an antihypertensive drug and very effective in the reduction of proteinuria especially in diabetic patients with nephropathy.

The recent detection of “N-nitrosodiethylamine (NDEA)”, a carcinogenic impurity in certain batches of the Irbesartan has prompted the manufacturers and suppliers to recall all the contaminated products.

Aurobindo Pharma Limited is an Indian based pharmaceutical company. All the 22 batches contaminated with the carcinogenic impurities were supplied to the ScieGen Pharmaceuticals, Inc.


Irbesartan is available by the following brand names in Pakistan.

  1. Aprovel and Co-Aprovel – SANOFI AVENTIS (PAKISTAN) LTD.
  2. Arbinen and Co-Arbinen – NENZA PVT LTD
  3. Arbi and Arbi-D – Pharmevo PVT LTD
  4. Co-Arbista and C0-Arbista Forte – Sante PVT LTD
  7. Hyponorm-H – Werrick pharmaceuticals
  8. Vepro – S.J. & G. Fazul Ellahie (PVT) LTD
  9. Zapose and Zepose plus – WILSHIRE LABORATORIES (PVT) LTD.

The recent detection of carcinogens as impurities in certain brands of irbesartan has again increased the uncertainty of essential medicines among its users, especially diabetic patients.

DON’T PANIC, Continue your antihypertensive medicines.

Patients in Pakistan and elsewhere, using Irbesartan salt should continue using the drug for several reasons.

  1. Withdrawal of antihypertensives may lead to a rise in the blood pressure leading to various end-organ complications – not less severe than cancer.

  2. Similarly, patients using irbesartan for proteinuria may end up with worsening diabetic nephropathy and renal function. Deterioration in renal function may lead ultimately to hemodialysis.

  3. The raw material for the brands being used here in Pakistan and most countries are not being marketed from the Indian based pharmaceutical company – Aurobindo Pharma Limited. Since there is a problem with impurities and not the drug itself, patients using these drugs need not panic and continue their medicines.

  4. Since ACE inhibitors have recently been associated with the development of lung cancer and valsartan brands have been recalled, we are left with only a few choices. However, if at all, patients want to shift to other antihypertensive medicines, some of the choices include
    1. Angiotensin Receptor Blockers: 
      1. Losartan
      2. Telmisartan
      3. valsartan
      4. Candesartan
    2. Calcium Channel Blockers:
      1. Amlodipine
      2. Nifedipine
      3. Nicardipine
    3. beta-blockers
      1. Atenolol
      2. Metoprolol
      3. Bisoprolol
      4. Carvedilol

Patients should consult their primary care physicians prior to changing their medicines.

Read More …

  1. FDA/ DRAP recalls Valsartan because of carcinogenic impurities
  2. Dapagliflozin launched in Pakistan
  3. Severe genital infections associated with the use of SGLT2 Inhibitors

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