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update on Folic Acid

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Coeliac New Zealand has been made aware that the Mylan brand of 5mg folic acid is now FOLIC ACID VIATRIS after a merger of Pfizer and Mylan.   The formulation has not changed.

Folic acid Viatris 5 mg contains maize starch and is therefore suitable for people with coeliac disease.

However the alternative dose of 0.8mg Folic Acid Multichem contains wheat starch, so the Multichem is not suitable for people with coeliac disease.

The appropriate dosage for individuals should be discussed with your GP or prescribing doctor. Supplementation and pregnancy dosing can vary.

Given that the lower strength 0.8mg Folic Acid Multichem is not gluten free, your doctor may choose to dose with the 5mg with a different schedule to achieve the recommended dose or recommend an over the counter product.

We are also aware of an over-the-counter medicine Blackmores Folic Acid which is 0.5mg and they advise they can claim ‘no added gluten’. The ‘No Added’ statement on Blackmores products means that none of the active and starting ingredients or excipients in that product contain gluten. However, we do not test for the absence of gluten at the end of every batch, therefore we cannot claim to be ‘gluten-free’ on the label. The risk of cross-contamination in food manufacturing is low but can occur. The risk of cross-contamination in Listed Medicines manufacturing is much lower, due to the stricter clean-down procedures between batches, however, the requirement to test the product still stands.

Pharmac also advises that if a patient cannot take a funded medicine due to an allergy or intolerance, they are eligible to apply for funding for a non-funded medicine via our exceptional circumstance’s pathway, Named Patient Pharmaceutical Assessment (NPPA). Non-clinical circumstances are not taken into account when assessing NPPA applications, for example, we do not consider a patient’s financial circumstances or personal preference for treatment when assessing an NPPA application. There must be a clinical need, supported by sufficient evidence, for the product being applied for. More information about NPPA is available on their website.

 

 

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