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 IU & 3,200 IU capsules are now approved for the treatment of vitamin D deficiency in pregnant women and breastfeeding mothers. Both strengths are prescription only medicines and the first licensed vitamin D3 preparations approved for the treatment of vitamin D deficiency 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.
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