PharmacovigilanceOfficial

AEMPS safety bulletin flags vitamin D errors, progestogen meningioma risk and tighter Litfulo use

🇪🇸 AEMPS · Thu 29 Oct 2026

Spain's medicines agency has issued its August–September 2026 safety bulletin, covering vitamin D overdose errors, meningioma with desogestrel and etonogestrel, ritlecitinib restrictions and new label safety information.

The Spanish Agency for Medicines and Medical Devices (AEMPS) published its Human Medicines Safety Bulletin for August and September 2026 on 29 October. It covers safety communications, new safety information from periodic evaluation of pharmacovigilance data, and risk minimisation materials authorised by the agency.

Among the communications, AEMPS reminds prescribers, dispensers and administrators to check the dosing schedule for the specific presentation in the SmPC and package leaflet before using vitamin D medicines. The Spanish pharmacovigilance system has continued to receive reports of serious hypercalcaemia linked to products containing calcifediol or colecalciferol. AEMPS also recommends strengthening the information given to patients and carers (Informative Note MUH (FV) 03/2026).

A safety letter to healthcare professionals addresses meningioma with desogestrel- and etonogestrel-containing medicines. An epidemiological study identified a small increase in risk with current, prolonged use of one year or more, estimated at about one extra case per 67,300 women treated with desogestrel. These products are contraindicated in women with meningioma or a history of it. Treatment should be stopped if meningioma is diagnosed, and prior exposure to progestogens known to raise the risk should be considered before starting therapy.

A second letter updates recommendations for Litfulo (ritlecitinib). The risks associated with JAK inhibitors—major adverse cardiovascular events, malignancy, serious infections and venous thromboembolism—are considered applicable to Litfulo in its authorised indication. It should be used only where no suitable alternatives exist in patients aged 65 or over, in those with atherosclerotic cardiovascular disease or other cardiovascular risk factors such as current or long-term smoking, and in those with malignancy risk factors. It should be used with caution in patients with other VTE risk factors, and periodic dermatological checks are recommended for all patients.

The bulletin also lists new safety information from periodic data evaluation, some already implemented and some to be added to SmPCs and leaflets, which can be checked in AEMPS's CIMA database. Items visible in the available text include atypical fractures of other bones, such as the ulna and tibia, with alendronate and alendronic acid/colecalciferol, and belzutifan entries on drug interactions, overdose and retinal oedema. The source text is truncated, so the full list of substances is not confirmed here.

What it means for your team

  • Marketing authorisation holders for desogestrel, etonogestrel and ritlecitinib products should check the AEMPS letters against their own labelling, DHPC distribution and educational materials.
  • Vitamin D (calcifediol, colecalciferol) products remain a medication-error focus in Spain; teams may review presentation-specific dosing information and patient communications.
  • Alendronate and alendronic acid/colecalciferol holders should watch for the atypical-fracture wording in Spanish SmPCs and leaflets; belzutifan holders should do likewise for its updates.
  • The available text is incomplete, so teams should consult the full bulletin and CIMA for product-specific actions.

Official source: AEMPS ↗

Article written by VigiEye from the official source (AEMPS). AI-assisted; check the source before acting.

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