Companies to replace all current formulations containing lactose with lactose-free formulations.
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that injectable methylprednisolone medicines containing lactose, 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.
In addition, patients being treated for an allergic reaction with methylprednisolone should have their treatment stopped if their symptoms worsen or they develop new symptoms.
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