July 3, 2013
Once again the EU was in the firing line this week, but the papers couldn’t quite decide who exactly to shoot. The Daily Express opted for “Now the EU bans Milk of Magnesia”, whilst “EU rules” were blamed for forcing “mother’s Milk of Magnesia off the shelves by The Daily Telegraph. Meanwhile, the Daily Mail chose to target “EU meddlers”.
None of them were correct. In fact, this is not a matter decided by the EU at all.
Phillips’ Milk of Magnesia is regulated and subject to the supervision of the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
A MHRA spokesperson said:
“The decision by Glaxo Smith Kline (GSK) to suspend the sale of Milk of Magnesia has not been made because of a safety issue. We are working with GSK to approve specific batches of Milk of Magnesia to ensure that supply problems are resolved and there are on-going discussions between the sulfate manufacturer and the European Pharmacopoeia Commission to ensure that normal supply is resumed quickly.”
· GSK have applied to MHRA to release specific batches where the sulfate limit is above the European Pharmacopeia specification, these variations include a safety summary from GSK.
· The MHRA has approved the batch specific variations to allow product to be placed on the market in the UK.
· The active pharmaceutical ingredient manufacturer has been in discussion with the European Pharmacopeia and at the last, most recent session on 18-19 June 2013, the European Pharmacopoeia Commission agreed to a request by the manufacturer to widen the limit in the test for sulfates and revise the method of determination; the reasons for the request were that ‘the sulfate is naturally occurring and it cannot be removed by manufacturing improvements to the specified limit of 0.5 percent. This product has been sold and used safely in pharmaceutical products for over 30 years without a sulfate specification, and other European Pharmacopeia monographs for similar use products have a sulfate limit of 1 percent’. This request has been agreed.
· For note MHRA has not recalled any product.
So what’s the European link?
The maximum limits of sulphate that can be present in magnesium hydroxide are set by the European Pharmacopoeia, not an EU body or agency, but part of the Council of Europe. They ensure legal and scientific standards for the quality control of medicines during development, production and marketing.
Too high a level of sulphate in milk of magnesia could form an unwanted side-product, magnesium sulphate, which in turn can cause serious central nervous system complications ranging from confusion and depression to slower respiratory rates and decreased blood pressure and in extreme cases even coma and respiratory paralysis.
The UK is one of 37 member states who are signatories to the Convention on the Elaboration of a European Pharmacopoeia. In addition, the World Health Organisation and 24 countries have “observer” status.
Membership enables participation in European Pharmacopoeia Commission sessions where member states are represented by national representatives who vote on all technical matters.Cloudy coverage on Milk of Magnesia – what the papers failed to tell you,
Tags:European Pharmacopeia, Glaxo Smith Kline, GSK, MHRA, Milk of Magnesia, sulfate