Ten Important Medicine Safety Updates — 11 August 2026

PharmExpert presents a review of new official medicine-safety materials identified through regulatory monitoring.

Key updates

1. Litfulo (ritlecitinib)

European regulators updated recommendations to minimise the risks of major adverse cardiovascular events, malignancy, venous thromboembolism, serious infections and mortality. Particular caution is required in patients aged 65 years or older, patients with cardiovascular or cancer risk factors, and current or long-term past smokers.

Sources: AIFA, HPRA, ANSM, BfArM, CBG-MEB.

2. ACE inhibitors

NMPA/CDE highlights delayed bradykinin-mediated angioedema. It may occur after weeks or years of treatment, cause airway obstruction and, rarely, death. Standard treatment for allergic reactions may be ineffective.

Source: NMPA/CDE Pharmacovigilance Express No. 7/2026.

3. Pivoxil-containing antibiotics

In children, these medicines have been associated with carnitine deficiency, severe hypoglycaemia, seizures and encephalopathy, including fatal cases.

Source: NMPA/CDE Pharmacovigilance Express No. 7/2026.

4. Pancreatin

Immunosuppressed patients receiving high daily doses should be informed about symptoms of viral hepatitis and the need to seek medical attention.

Source: Kazakhstan NDDA.

5. Gemcitabine

Severe cutaneous adverse reactions are being added to product information: Stevens–Johnson syndrome, toxic epidermal necrolysis, DRESS and acute generalised exanthematous pustulosis. These reactions may be life-threatening or fatal; treatment must be stopped immediately if symptoms occur.

Source: Ukraine SEC.

6. Valproate and related substances

A potential risk of neurodevelopmental disorders remains for children following paternal exposure to valproate during the three months before conception. Patient counselling, effective contraception, avoidance of sperm donation and regular treatment review are recommended.

Source: Ukraine SEC.

7. Iodinated contrast media

Fixed drug eruption, including bullous generalised forms, has been identified as a class risk. Re-exposure may lead to recurrence and potentially more severe reactions.

Source: Ukraine SEC safety update.

8. Djubonti (denosumab)

Risk-minimisation materials reinforce the risk of osteonecrosis of the jaw, the importance of dental assessment, oral hygiene and prompt reporting of oral symptoms.

Sources: Ukraine SEC detail page and patient reminder card (PDF).

9. Drospifem

Updated educational materials address the risk of venous thromboembolism associated with combined hormonal contraceptives and support early recognition of warning signs.

Sources: Ukraine SEC communication package; PDF 1, PDF 2, PDF 3.

10. Dezofemin

Materials for healthcare professionals and patients clarify the risk of venous thromboembolism and the symptoms requiring urgent medical attention.

Sources: Ukraine SEC materials for healthcare professionals, patient information card and patient card (PDF).

This material is intended for healthcare professionals and is informational. Treatment decisions should be based on the approved product information and individual clinical assessment.