Regulatorische Updates

MHRA alerts that the transition to a new Rybelsus® tablet formulation, with different labeled doses but bioequivalent, may cause medication errors and patient harm.

The UK Medicines and Healthcare products Regulatory Agency has re‑examined safety warnings on gabapentin, pregabalin, benzodiazepines and Z‑drugs, with findings published in a Public Assessment Report.

The CHM has endorsed updated risk‑minimisation measures for isotretinoin after reviewing the 2023 measures, urging healthcare professionals to review them.

The MHRA has revised product information for all GLP‑1 and dual GLP‑1/GIP receptor agonists to emphasize the risk of acute pancreatitis, including necrotising and fatal cases.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) notes that non‑arteritic anterior ischemic optic neuropathy (NAION) has been reported very rarely in patients using semaglutide (Wegovy, Ozempic, Rybelsus).

MHRA’s safety review leads to IXCHIQ vaccine no longer being indicated for adults over 60 years.

A counterfeit tirzepatide (Mounjaro) KwikPen 15 mg batch D873576 was identified from a UK online pharmacy, prompting a safety alert.

MHRA warns that nasal decongestant sprays containing xylometazoline or oxymetazoline can cause rebound congestion when their effect wears off.

The UK regulator advises new measures to reduce suicide risk linked to finasteride and dutasteride.

Amiodarone linked to life‑threatening lung, liver and thyroid side effects; MHRA urges healthcare professionals to supervise and review patients.

Healthcare professionals warned of delayed angioedema onset and need to differentiate bradykinin‑ and histamine‑mediated cases, as treatments differ.

The UK Medicines and Healthcare products Regulatory Agency reports cases of iatrogenic botulism after therapeutic or cosmetic use of botulinum toxin type‑A, urging immediate medical attention if symptoms arise.