The MHRA has issued advice relating to the potential for allergies to two commonly used imported vitamin products, Dekristol capsules and Vigantoletten tablets.
Both products are imported from Germany and hence the main concern is that the Patient Information Leaflets are in German rather than English. There is currently no legal requirement for imported medicines to be labelled in English, however, the expectation is that suitable English language labelling will be provided as a matter of good practice. It therefore falls to pharmacists to provide relevant information on the dispensing label as well as to inform prescribers of the issues.
Dekristol capsules contain colecalciferol 20,000 IU, a vitamin D analogue used for deficiency states. One of the excipients of the capsules is arachis oil (peanut oil) and they are therefore contra-indicated in patients with nut allergies.
Vigantoletten tablets are colecalciferol 1000 IU and contain the excipient soya oil and are therefore contra-indicated in patients with allergy to soya.
Allergy to both arachis oil and soya oil can result in severe allergic reactions including anaphylaxis and so pharmacists must inform prescribers prior to ordering the products. It would also be advisable to confirm with the patient upon dispensing that they do not suffer from an allergy to the respective excipient.
The MHRA alerts can be viewed via the following links:
www.mhra.gov.uk/Publications/Safetywarnings/DrugAlerts/CON140797
www.mhra.gov.uk/Publications/Safetywarnings/DrugAlerts/CON140798
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