Methylprednisolone injections containing lactose should not be given to patients with known or suspected cow’s milk allergy, the European medicines regulatory body has concluded.
The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), the regulatory authority for the European Union (EU), Iceland, Liechtenstein and Norway, issued the recommendation following advice from the European Medicines Agency (EMA).
An EMA review of methylprednisolone injections was initiated in December 2016 after serious allergic reactions, including bronchospasm and anaphylaxis, were reported in patients with cow’s milk protein allergy who were treated for acute allergic conditions with these medicines. In the subsequent analyses, the adverse reaction was sometimes misinterpreted as lack of therapeutic effect, leading to re-administration of methylprednisolone and subsequent worsening of the patient’s condition. Since methylprednisolone is used to treat severe allergic reactions in an emergency setting where details of the patients’ allergies may not always be known, the CMDh has concluded that the most effective way to minimise the risk is to remove cow’s milk proteins from the preparation.
Companies have been asked to provide data allowing the replacement of formulations containing lactose from cow’s milk. This data should be provided by mid-2019.