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Fultium-D3 800 IU & 3,200 IU capsules: first vitamin D3 to be approved for use in pregnant women and breastfeeding mothers

Fultium-D3 800 & 3,200 capsules are now approved for the treatment of in pregnant women and breastfeeding mothers. Both strengths are prescription only medicines and the first licensed vitamin D3 preparations approved for the treatment of in these ‘at-risk’ groups.

Vitamin D deficiency is a serious and increasing UK public health priority, affecting up to 20% of the UK population.1 In 2012 the UK Chief Medical Officers took the step of alerting healthcare professionals to their concern about the increasing prevalence of vitamin D deficiency; its potential long-term impact on health2 and they advocated preventative treatment for ‘at-risk’ groups.2 Vitamin D deficiency in pregnant women and breastfeeding mothers can lead to inadequate development of foetal stores of vitamin D in early infancy.2

Fultium-D3 800 IU and 3,200 IU capsules meet all the strict licensing criteria required by the Medical and Healthcare Products Regulatory Agency (MHRA), ensuring that a reliable and consistent dose is given to people with vitamin D deficiency. Tests have shown significant inaccuracies and worrying variations in the labelled dose of off-the-shelf products that have not been licensed by the MHRA; this places patients at risk of under treatment or toxicity.3, 4 Healthcare professionals can therefore be confident that they are free from the medico-legal risks associated with prescribing a product with no prescription licence.3

Dr Pam Brown, GP, Swansea, commented: “Pregnant and breastfeeding mothers are encouraged to take vitamin D to support them throughout pregnancy and while breastfeeding. The 800 IU and 3,200 IU licence updates are great news for prescribers like myself because it is essential that I can offer these patients a licensed treatment that offers quality and a regulated dose.”

Chief Operating Officer of Internis, Paul Tredwell commented: “We’re excited to be able to offer an extended range of Fultium-D3. Both of these Fultium-D3 capsule strengths were previously only licensed for the treatment and prevention of vitamin D deficiency in adults and the elderly. This is the first vitamin D product available on prescription with a posology for pregnant and breastfeeding mothers for the treatment of deficiency.”

Fultium-D3 800 IU and 3,200 IU capsules is available on prescription in packs of 30 and 90. Following an initial high-dose correction treatment for up to 12 weeks of the 3,200 IU dose, the 800 IU capsules can be prescribed as a long term maintenance dose for prevention of deficiency.

Source

1. Food Standards Agency, National Diet and Nutrition Survey Headline results from Years 1, 2 and 3 (combined) of the rolling programme (2008/2009 – 2010/11) https://www.gov.uk/government/publications/national-diet-and-nutrition-survey-results-from-years-1-to-4-combined-of-the-rolling-programme-for-2008-and-2009-to-2011-and-20122 Last accessed February 2015

2. CMO letter, Vitamin D – advice on supplements for at risk groups, https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/213703/dh_132508.pdf Last accessed February 2015

3. Davies, JS et al. The medico-legal aspects of prescribing vitamin D. British Journal of Clinical Pharmacology. DOI: 10.1111/bcp.12472 http://onlinelibrary.wiley.com/doi/10.1111/bcp.12472/abstract Last accessed February 2015

4. Garg S, et al. Evaluation of vitamin D medicines and dietary supplements and the physicochemical analysis of selected formulations. The Journal of Nutrition, Health & Aging. 2013; 17(2), 158-61. doi:10.1007/s12603-012-0090-4

Source: Internis Pharmaceuticals