Yellow Card Scheme/Liothyronine

The request was partially successful.

Dear Medicines and Healthcare products Regulatory Agency,
Firstly, a Happy New Year to the team. I am very grateful to you all for the generosity of time and the trouble you take to make sure everything is worded correctly. There is too much ambiguity at the moment surrounding the prescribing of Liothyronine, so I write again.

1. Can the MHRA confirm if the yellow card scheme individual adverse symptoms/reactions reported to the Agency are codified, with possibly age, gender also noted? This is in respect of both Levothyroxine and Liothyronine.

2. Please can you confirm the source country of manufacture of all licenced Liothyronine products currently available in the UK? An Endocrinologist in 2018 stated to a patient that as far as they are concerned all liothyronine products are produced by just the one company, formerly Concordia and now known as Advanz Pharma. In a previous FOI to yourselves you stated that there were two manufacturers in the UK and one abroad.

3. A previous FOI to yourselves regarding Liothyronine and the UK's unique tablet strength of 20 mcg rather than 25 mcg marketed in the rest of the world - suggested that this 20 mcg was because this particular tablet strength was linked to the dosage of the injectable liothyronine necessary for thyrotoxicosis patients. If the rest of the world has Liothyronine in 25 mcg tablet and injectable it suggests that there has to be another more plausible reason.
What other reasons does the MHRA have for not allowing 25 mcg liothyronine tablet strengths to be licenced and available for prescribing in the UK?

Thank you again.
Yours faithfully,
Linda

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 19/004

Dear Linda Sanday,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 4 January 2019.


I confirm that your request is being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.

Kind Regards,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

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FOILicensing, Medicines and Healthcare Products Regulatory Agency

1 Attachment

Dear Ms Sanday,

 

Thank you for your email dated 04 January 2019, where you requested
information regarding liothyronine. Please find our response attached.

 

Kind regards,

FOI Licensing Team

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