Current formulations containing lactose will be replaced with lactose-free formulations

The CMDh has endorsed the recommendation of EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) that methylprednisolone injections containing lactose (milk sugar), which potentially contain traces of cow’s milk proteins, must not be used in patients with a known or suspected allergy to the proteins in cow’s milk.

CMDh further confirmed that patients being treated with methylprednisolone for an allergic reaction should have their treatment stopped if their symptoms worsen or they develop new symptoms.

Methylprednisolone injections are used to treat the symptoms of severe allergic reactions and other inflammatory conditions. The review of these medicines was triggered following reports of serious allergic reactions such as bronchospasm (excessive contraction of the airway muscles causing breathing difficulty) and anaphylaxis (sudden severe allergic reaction) with these medicines in patients allergic to cow’s milk proteins. The review found that methylprednisolone injections containing lactose derived from cow’s milk may also contain traces of cow’s milk proteins which can trigger allergic reactions. This is of particular concern in patients already being treated for an allergic reaction as they are more prone to developing new allergic reactions. In this case it may be difficult to determine whether the patient’s symptoms are due to a new allergic reaction caused by methylprednisolone products containing lactose or due to a worsening of the original condition. This may lead to additional doses being given which will further worsen the patient’s condition.

CMDh agreed with the PRAC’s conclusion that there is no level of cow’s milk proteins that can be considered safe for these medicines when used to treat severe allergic reactions. Considering that methylprednisolone is used for the treatment of severe allergic reactions in an emergency setting where details of the patients’ allergies may not always be known, the CMDh confirmed that the most effective way of minimising any risks 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 the middle of 2019.

In the meantime, the product information will be revised to reflect that methylprednisolone injections containing lactose must not be given to patients allergic to cow’s milk proteins. In addition, the vial and packaging of these medicines will be clearly marked with a warning against use in patients with cow’s milk allergy.

Posted on the EMA website on 1 August 2017