Solu-Medrone 40mg (Methylprednisolone sodium succinate) contains lactose produced from cow’s milk as an excipient and may contain trace amounts of milk proteins. Consequently this product should not be used in patients with cows’ milk protein allergy.

The Summary of Product characteristics (SPC) for Solu-Medrone 40mg contra-indicates its use in “patients with a known or suspected allergy to cows’ milk or its components, or other dairy products, because it contains trace amounts of milk ingredients”. The SPC was updated on 8th November 2017 to reinforce this advice.

Other strengths of Solu-Medrone (125mg, 1g, 2g and 500mg) do not contain lactose and are safe to use in patients with a known or suspected allergy to cows’ milk.

Methylprednisolone is a corticosteroid with mainly glucocorticoid activity. Clinically injectable methylprednisolone has a variety of indications including the relief of seasonal and perennial allergies, skin conditions such as severe erythema multiforme (Stevens-Johnson syndrome) and gastro-intestinal diseases including ulcerative colitis or Crohn’s disease.

European Review

A recent EU review revealed that allergic reactions including bronchospasm and anaphylaxis in patients with known cows’ milk allergy have been reported following treatment with injectable methylprednisolone containing lactose derived from cows’ milk. Most of the patients affected were younger than 12 years old and had a diagnosis of childhood asthma.

In some cases the symptoms were misdiagnosed as the patient not responding to the treatment and the methylprednisolone was re-administered leading to a worsening of the patient’s clinical condition.

Cows’ milk allergy

Cows’ milk allergy is an immunological reaction to the protein in cows’ milk. It is one of the most common childhood food allergies in the developed world, being second only to egg allergy.

Cows’ milk protein allergy affects approximately 7%[1] of formula or mixed-fed infants (combination of formula and breast milk), occurring most commonly in the first year of life.  The incidence of cows’ milk protein allergy in exclusively breast fed infants is significantly lower. The allergic reaction in breast fed infants is triggered by cows’ milk protein from the mothers’ diet being transferred to the infant through breast milk.

Over half of children diagnosed with IgE mediated cows’ milk allergy will outgrow the condition by the age of 5 years, whilst most children with non IgE –mediated allergy will be milk tolerant by the age of 3 years1.

For more information on cows’ milk protein allergy see the Pharmacy Excellence module “Specialist infant formulae and the management of infant problems” available on the Numark online training platform

Advice for healthcare professionals

Healthcare professionals are advised that 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 interim healthcare professionals are advised:

  • Solu-Medrone 40mg uses lactose 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
  • Injectable methylprednisolone that contains lactose should not be used in patients with a known or suspected cows’ milk allergy
  • If a patient’s symptoms worsen or new symptoms appear an allergic reaction to cows’ milk protein should be suspected, administration of the product should stop and the patient’s condition be treated accordingly
  • Suspected adverse reactions, including during the treatment of allergic conditions, should be reported through the Yellow Card Scheme

[1] Cows’ milk protein allergy in children- NICE Clinical Knowledge Summary!topicsummary - accessed November 2017