Safety Information

Revised: 27 June 2013

Eltroxin formulation change - Monitor patients and adjust dosing if necessary

Advice from Medsafe – 26 June 2008

Eltroxin formulation change – Monitor patients and adjust dosing if necessary

Medsafe is writing to provide information and advice on the change in formulation of Eltroxin (levothyroxine, also known as, thyroxine) tablets which has led to a number of patients reporting problems such as sore eyes, palpitations, and headaches.

In response to these reports, Medsafe has reassessed the change in Eltroxin formulation and can confirm that the new formulation satisfies all quality, safety, and bioequivalence criteria. In addition, all excipients and excipient quantities present in the new formulation are commonly used in medicines.

Treatment of thyroid dysfunction is subject to significant inter-patient variability. Therefore, when patients are changed to new formulations or brands of levothyroxine, thyroid function monitoring is required to ensure the correct dose is being prescribed. Small changes in dosing of levothyroxine can affect serum thyroid hormone levels.

When changing a patient to the new Eltroxin formulation, Medsafe advises that:

Additional factors to consider when prescribing Eltroxin tablets:

For further advice relating to Eltroxin tablets, please contact the manufacturer (GSK) on 0800 808 500 (Monday to Friday 11 am – 6pm).

The new formulation of Eltroxin is the only brand of levothyroxine that has ministerial consent for distribution in New Zealand. Medsafe does not have any applications for levothyroxine tablets from any other pharmaceutical companies. Unapproved medicines (which includes other brands of levothyroxine) can only be supplied under provisions in the Medicines Act (Section 25 and 29) that require an authorised prescriber to request or obtain the medicine for a specific patient under their care.

Further information on the use of unapproved medicines in New Zealand

Medsafe’s media release is also available