In November 2020, Solu-Medrone 40 mg was reformulated to a lactose-free formulation in which the lactose was replaced by sucrose — see letter for healthcare professionals.
Advice for healthcare professionals:
- Solu-Medrone 40 mg uses lactose produced from cows’ milk as an excipient and may contain trace amounts of milk proteins; other strengths of Solu-Medrone do not contain lactose
- serious allergic reactions have been reported in patients allergic to cows’ milk proteins
- do not use injectable methylprednisolone medicines that contain lactose in patients with a known or suspected allergy to cows’ milk
- if a patient’s symptoms worsen or any new allergic symptoms occur, allergic reaction to cows’ milk proteins should be suspected; stop administration of the product and treat the patient’s condition accordingly
Methylprednisolone is a corticosteroid with a wide variety of indications including allergic states, dermatological disease, and gastrointestinal diseases.
A recent EU review reported cases of allergic reactions, including bronchospasm and anaphylaxis, in patients allergic to cows’ milk proteins treated with injectable methylprednisolone products containing lactose of bovine origin. Most patients were younger than 12 years and had childhood asthma. In some of the reported cases the adverse reaction was misinterpreted as a lack of therapeutic effect, leading to re-administration of methylprednisolone and subsequent worsening of the clinical condition of the patient.
Lactose-containing methylprednisolone medicines will be reformulated to remove any trace of milk proteins. Companies have been asked to take steps towards lactose-free formulations by 2019.
In the meantime, a
has been sent to communicate the new restriction and warnings.
About cows’ milk allergy
Cows’ milk allergy is an adverse reaction of an immunological nature induced by cows’ milk proteins. Estimates of prevalence of cows’ milk allergy based on food challenge vary from 0% to 3%. Most children outgrow their allergy in early childhood and only a small proportion of patients remain allergic in adulthood.
Cows’ milk allergy should be clearly distinguished from lactose intolerance, which is a non-immunologically mediated reaction to milk caused by a lack of the enzyme lactase in the small intestine, which breaks lactose from milk down into glucose and galactose.
Call for reporting
Any suspected adverse reactions, including during treatment of allergic conditions, should be reported to us on a Yellow Card.
. Solu-Medrone 40 mg. October 2017.
CMDh confirms that methylprednisolone injections containing lactose must not be given to patients allergic to cow’s milk proteins. August 2017.
Article citation: Drug Safety Update volume 11 issue 3, October 2017: 1.
Published 26 October 2017