Unlicensed imported vitamin D (colecalciferol) capsules: potential peanut oil and soya oil allergens
- Medicines and Healthcare products Regulatory Agency
- 11 December 2014
- Therapeutic area:
- Nutrition and dietetics
Healthcare professionals should be aware that these capsules contain potential allergens.
Article date: March 2012
Vigantoletten and Dekristol vitamin D (colecalciferol) capsules are unlicensed medicines in the UK. However, they are legitimately imported and supplied in their original German language livery for the special needs of individual patients only on prescription under the direct responsibility of the prescriber. The German labelling of these products states that Vigantoletten capsules contain soya oil, and that Dekristol capsules contain arachis (peanut) oil. This is unlikely to be evident to non-German speakers. Healthcare professionals should be aware that these capsules contain potential allergens.
Furthermore, imported unlicensed vitamin D Osto D2 capsules from Canada and Drisdol capsules from the USA may pose a similar allergen risk. Although labelled in English, the products may not explicitly state that they contain soya oil.
Advice for healthcare professionals:
- allergy to soya oil or arachis oil may lead to severe allergic reactions, including anaphylaxis
- these products are contraindicated in patients with relevant allergies. Doctors and pharmacists should enquire whether patients have any relevant allergies before supplying these medicines
- importers are advised that prescribers must be made aware of this contraindication
Drug safety information for Vigantoletten capsules
Drug safety information for Dekristol capsules
Unlicensed or off-label use of medicines: prescribers’ responsibilities
Article citation: Drug Safety Update March 2012, vol 5 issue 8: S2.
Published: 11 December 2014
Therapeutic area: Nutrition and dietetics