23 October 2008
Medsafe approves two additional levothyroxine products
The Ministry of Health's drug regulatory arm Medsafe has given provisional approval to two products containing
levothyroxine. This will allow patients in New Zealand to have access to an approved alternative to Eltroxin.
The products are Synthroid, manufactured by Abbott Laboratories, which is also sold in Canada, and Levothyroxine,
manufactured by Goldshield, which is also sold in the United Kingdom.
The provisional consent limits use of the products to initiation of treatment in new patients, and use in patients who
are intolerant or unable to take another brand of levothyroxine. The Medsafe data sheets for the products will reflect
these restrictions and each company will be required to notify prescribers and pharmacists of the increased need to
closely monitor patients who switch brands of levothyroxine.
Medsafe group manager Dr Stewart Jessamine says "Following our evaluation of the data supplied in the applications,
Medsafe is satisfied that both Levothyroxine and Synthroid are safe and effective alternatives to Eltroxin, however as
neither application provided adequate evidence of bioequivalence use of these products will require careful monitoring
if patients wish to avoid adverse effects."
Dr Jessamine said: "while changing to a new levothyroxine product will resolve many of the problems reported by patients
taking Eltroxin, patients changing to these new brands will still need to have their blood tests monitored and are
likely to require the dose of the new brand adjusted to suit their individual metabolism". PHARMAC Medical Director Dr
Peter Moodie said the provisional consent given to the Goldshield brand means that it will be fully funded from 1
November. This was in line with the proposal PHARMAC consulted on from late September, he says. The existing funded
brand of levothyroxine, Eltroxin, will also continue to be fully funded. PHARMAC has been able to put in place
arrangements to ensure that when funding for Goldshield begins on 1 November, there will be sufficient stock to meet the
expected demand. "We are very grateful to the efforts of Goldshield's supplier, Boucher & Muir, for getting stocks to New Zealand rapidly," said Dr Moodie. "We understand that stock is in the country this
week, and will be distributed to wholesalers next week. This will ensure that should people require a prescription for
Goldshield's brand of levothyroxine to be filled from 1 November, they will be able to do so." Dr Moodie says PHARMAC
has no plans to fund Synthroid at this time, however it remains open to the possibility of funding it in the future.
Full background to this issue, including a timeline, questions and answers and previous media releases is available by
clicking the following link: http://www.moh.govt.nz/moh.nsf/indexmh/eltroxin?Open