Other safety alerts
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| The United Kingdom: Methylprednisolone injectable medicine containing lactose (Solu-Medrone 40 mg): do not use in patients with cows’ milk allergy |
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The Medicines and Healthcare products Regulatory Agency (MHRA) announces that 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.
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.
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.
Healthcare professionals are advised:
- 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;
- not to use injectable methylprednisolone medicines that contain lactose in patients with a known or suspected allergy to cows’ milk; and
- 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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/methylprednisolone-injectable-medicine-containing-lactose-solu-medrone-40-mg-do-not-use-in-patients-with-cows-milk-allergy
In Hong Kong, there are 8 registered pharmaceutical products which are injectable methylprednisolone. Amongst them, only Solu Medrol 40mg Steril Mix-O/Act-O Vial (HK-00466) contains both methylprednisolone and lactose, which is registered by Pfizer Corporation Hong Kong Limited and is a prescription-only medicine. So far, the Department of Health has received 4 cases of adverse drug reaction related to methylprednisolone, but these cases were not related to allergic reactions.
Related news has been released by EMA and Health Canada, and was posted on the Drug Office website on 3 December 2016, 8 July 2017, 2 August 2017 and 7 September 2017. Letters to inform healthcare professionals to draw their attention on the issue was issued on 10 July 2017. As previously reported, the matter with the above information announced by the MHRA will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, October 27, 2017
Issued at HKT 16:30
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