Freedom of Information request on reclassification of antihistamines (FOI 21/802)
Published 29 December 2021
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23rd July 2021
FOI 21/802
Dear
Thank you for your information request, dated 27 May 2021, where you asked for the following information relating to reclassification of non-sedating antihistamines:
- any minutes from MHRA meetings held during the past year in which the reclassification of sedating antihistamines has been discussed;
- any reports produced or considered by the MHRA during the past year in which the reclassification of sedating antihistamines has been mentioned;
- detail of any reviews that have been carried out, are currently ongoing, or are planned to look into the possible reclassification of sedating antihistamines.
I can confirm that we do not hold any information relating to a change of legal status (i.e. prescription only medicine (POM), pharmacy (P) or general sales list (GSL)) of any sedating antihistamine currently or within the last year.
However, whilst this is not a change in legal status of the product, I do wish to inform you that for Nytol Liquid Caramel Flavour 10mg/5ml oral solution (diphenhydramine, PL 02855/0313) the Pharmacy (P) indications limited and is no longer indicated in children under 16. You can find further information in the Direct Healthcare Professional Communication.
If you have a query about the information provided, please reply to this email. I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.
Yours Sincerely,
FOI Team,
Vigilance and Risk Management of Medicines Division