DRUG ALERT: Valsartan Recall

valsartan alert

The UK Medicines and Healthcare products Regulatory Agency’s (MHRA) has asked all pharmacies in the UK to recall all batches of valsartan-containing medicines made by Dexcel Pharma Ltd and Accord Healthcare (previously known as Actavis Group) as a precaution. This follows an urgent investigation in to medicines containing valsartan used to treat high blood pressure and heart conditions.

The recall is also underway across Europe, and follows identification of an impurity, N-nitrosodimethylamine, in valsartan-containing drugs manufactured at a facility based in China. This impurity may have cancer-causing properties, and the withdrawal is a precaution only.

If you are taking any of the affected valsartan products, the MHRA advises that it is vital that you do not stop taking your medication, but you should contact your doctor as soon as possible. Your doctor can assess your treatment and switch you to another valsartan-containing product that is not affected by this issue.

If your valsartan product is not made by the two identified manufacturers ( Dexcel Pharma Ltd and Accord Healthcare) you are not affected. However, if you are concerned, please speak to your GP, pharmacist or other healthcare professional.

The MHRA add that they strongly encourage anyone taking valsartan medicines to report any suspected side effects, via their Yellow Card Scheme.

What is valsartan?

Valsartan is an angiotensin II receptor blocker (ARB) which blocks the effects of an enzyme, angiotensin II. This reduces blood vessel constriction and allows arteries to dilate. Valsartan also stimulates kidney function and are useful as an alternative to ACE inhibitor drugs for people who develop a persistent dry cough, as ARBs do not produce this problem.

Valsartan 40 mg capsules are used to treat two different conditions:

  • recent heart attack  (between 12 hours and 10 days)
  • symptomatic heart failure when an Angiotensin Converting Enzyme (ACE) inhibitors cannot be used or it may be used in addition to ACE-inhibitors when other medications to treat heart failure cannot be used. Heart failure symptoms include shortness of breath and/or swelling of the feet and legs due to fluid retention when the heart muscle cannot pump blood strongly enough around the body.

Valsartan 80 mg and 160 mg capsules are used to treat three different conditions:

  • high blood pressure 
  • recent heart attack (between 12 hours and 10 days)
  • symptomatic heart failure.

If you are uncertain whether or not the valsartan you are taking is affected, please contact your doctor or a pharmacist for advice.

About Dr Sarah Brewer

QUORA EXPERT - TOP WRITER 2018 Dr Sarah Brewer MSc (Nutr Med), MA (Cantab), MB, BChir, RNutr, MBANT, CNHC qualified from Cambridge University with degrees in Natural Sciences, Medicine and Surgery. After working in general practice, she gained a master's degree in nutritional medicine from the University of Surrey. Sarah is a registered Medical Doctor, a registered Nutritionist and a registered Nutritional Therapist. She is an award winning author of over 60 popular self-help books and a columnist for Prima magazine.

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