The Aemps indicates that “It is well known that drugs containing vitamin D can cause hypercalcemia. Despite this, the Spanish Pharmacovigilance System continues to be notified of serious cases due to the drug overdose that contain a form of vitamin D as the only active ingredient. Hypercalcemia consists of elevated plasma calcium levels and can cause heart rhythm disorders and peptic ulcers.
“Specifically, the reported cases are related to overdose of preparations with cholecalciferol in children and calcifediol in adults. According to the data available in the notifications, these cases are related to errors that can occur both in the prescription, in the dispensing or in the administration of the medication”, indicates the Aemps.
“It is recalled that, for use in pediatrics, cholecalciferol as a monodrug is marketed as:
Oral drops for daily administration: Deltius® and Thorens® 10,000 IU/ml (1 drop contains 200 IU); Vitamin D3 Kern Pharma 2,000 IU/ml (3 drops or 0.1 ml contain 200 IU).
blisters drinkable for administration every 6-8 weeks according to the age of the child: Videsil® 25.0000 IU oral solution. Its use should be reserved for those cases in which daily administration is not possible.
The Aemps too establishes the commercialized presentations of calcifediol for adults (Hydroferol®):
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Daily administration: Hidroferol® oral drops: 6000 IU/ml (25 drops) (240 IU/drop).
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Monthly administration: Hidroferol® 0.266 mg capsules and oral solution: 16,000 IU per capsule or drinkable ampoule.
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Single administration: Hidroferol® shock 3 mg oral solution: 180,000 IU per drinkable ampoule.
As a precautionary measure, the Spanish Agency for Medicines and Health Products reminds healthcare professionals to “Make sure that the presentation, the dose per dose and the frequency of administration are clearly noted on the prescription. Confirm that the product is being administered correctly at subsequent medical visits. In the case of newborns and infants: clearly explain to the parents, guardians or carers the administration schedule of the prescribed medicine and make sure that it has been correctly understood. In the case of adults: clearly explain to the patients the administration schedule of the prescribed medicine, placing special emphasis on the frequency of its administration, making sure that the patient understands it.
As for the pharmaceutical professionals, warns that they should “verify that the presentation and frequency of administration are appropriate for the situation, before dispensing and at the time of dispensing, review with parents/patients that they know exactly the prescribed dosage regimen.”
The Aemps seeks through its professionals to inform the public of all alerts regarding the quality and supply of medicines in Spain