Health Ministry Confirms Vitamin D Supplements Contained 300 Times The Labelled Dose
A Vitamin D supplement available on the Maltese market and commonly used by pregnant women has been confirmed to have 300 times the levels of vitamin D than what was declared on the label, the Health Ministry has confirmed .
Public health authorities issued an urgent call on Monday for consumers to stop taking Folidi after discovering it had excessive levels of vitamin D.
Earlier today a spokesperson from the Health Ministry confirmed to Lovin Malta that these levels were 300 times higher.
Each tablet was labelled as containing 2,000 IU (0.05 mg) of vitamin D3, but actually had 600,000 IU (15 mg) – 300 times more. The recommended maximum daily intake is just 4,000 IU (0.1 mg).
High vitamin D levels can lead to elevated blood calcium, a condition called hypercalcemia.
Symptoms of hypercalcemia can range from mild to severe and include digestive issues, muscle weakness, fatigue, confusion and in severe cases, kidney problems and irregular hearth rhythms. Hypercalcemia in pregnancy can be further complicated by the fact that it is asymptomatic, or presents with symptoms which can be easily confused with nausea and other discomforts frequently observed in pregnancy. The effects of the condition can range from minor to severe on both the mother and the fetus.
It is associated with maternal complications such as urolithiasis, pancreatitis, renal insufficiency and preeclampsia, and fetal complications such as growth restriction and intrauterine fetal demise, and neonatal complications such as neonatal hypocalcemia, tetany and hypoparathyroidism.
Information on Folidi so far
The Health Minsitry spokesperson confirmed that available records suggest only one batch was imported from this product however. They did not specify how big the shipment was and how much of it had been sold. They further stated that the issue appeared to originate from the manufacturer level outside of Malta.
Health authorities are currently gathering information from the agents involved.
Product safety concerns came to light after a number of patients started presenting with abnormal calcium levels and high vitamin D levels.
Through clinical collaboration between Gozo General Hospital, Mater Dei Hospital and the Malta National Poisons Centre, it was identified that these patients had attended medical care with similar symptoms – high vitamin D and calcium levels – and were on the same food supplements. The public health authority was alerted and samples were sent for analysis. The product has since been recalled from the market.
It is still too early to know the exact number of patients affected as data is still being collected however, the Health Ministry currently knows of at least nine patients who have presented with high vitamin D or calcium levels.
The health authorities issued an alert to the general public, doctors and pharmacists so any patients who consumed this product would stop the product and communicate with the poisons centre. Like this, each case can be individually assessed and the ministry will get a more accurate number of people affected.
“More patients are expected to come forward,” the spokesperson said.
The Malta National Poisons Centre is leading clinical patient management. All individuals who were at any point taking this supplement are being advised to contact the Malta National Poisons Centre on 1774 between 8am-8pm, Monday to Sunday for an individual risk assessment and management plan.
Was your health impacted by this faulty batch of Folidi? Reach out to [email protected] or [email protected] to share your story
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