MHRA downplays fears over additives in children's meds
Clinical The medicines watchdog has said that it does not grant medicine licences containing additives unless their use is justified
The MHRA has downplayed calls for a ban on e-numbers in children's medication, highlighting that foods contain much higher quantities of the additives.
Manufacturers must justify using additives before a medicine licence is granted, the medicines watchdog stressed this week (October 22), in response to a report published the same day that criticised the use of colourings in children's medication.
The report, published by charity Action on Additives, named 52 children's medicines containing the seven e-number colourings and preservatives that were linked to hyperactivity in a 2007 Southampton University study.
Licences are not granted for medicines that contain additives without justification, says the MHRA |
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The additives included carmoisine, quinoline yellow and ponceau 4R – all banned in food in the USA, Canada and Japan – and others linked to hyperactivity and allergies, such as sunset yellow. The Food Standards Agency called for a voluntary removal of all these ingredients from foods in 2008. |
Action on Additives said it was concerned by the amount of "unnecessary" colourings in OTC, pharmacy-only and prescription medicines and called on manufacturers to withdraw these ingredients.
But the MHRA said it did not grant licences for medicines that contained additives without justification and highlighted that a full list of ingredients was readily available on patient information leaflets.
"We are aware that some additives can cause an unwanted reaction in a small number of people and we are continually monitoring their safety profile," said Siu Ping Lam, MHRA acting director of licensing. "This helps us to provide accurate information about any risks to patients and healthcare professionals."
Boots, which manufactured four of the products named in the report, said customer safety was "of paramount importance" to the multiple. It stressed that the additives mentioned were commonly present in MHRA-approved medicines and said colourings were important in helping patients to identify medicines on sight.
Read the full list of medicines mentioned in the report here.
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