BRUSSELS, Aug. 1 (Xinhua) -- The Co-ordination Group for Mutual Recognition and Decentralised Procedures -- Human (CMDh) on Tuesday decided that methylprednisolone injections containing lactose must not be used in patients with a known or suspected allergy to the proteins in cow's milk, said a press release by European Medicines Agency (EMA) .
This recommendation was proposed by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which is responsible for the evaluation of safety issues for human medicines, and it was endorsed by CMDh.
Methylprednisolone-containing medicines have been authorised for use by injection into a vein or muscle and have been available for many years in the European Union (EU) under a variety of brand names including Solu-Medrol to treat the symptoms of severe allergic reactions and other inflammatory conditions.
However, PRAC carried out a review of the medicine and concluded that methylprednisolone injections containing lactose derived from cow's milk may also contain traces of cow's milk proteins which can trigger allergic reactions.
Thus, 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 and may lead to additional doses being given which will further worsen the patient's condition, according to the release.
The CMDh is a body representing EU member states as well as Iceland, Liechtenstein and Norway. It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
