News Video | Policy | GPs | Hospitals | Medical | Mental Health | Welfare | Search

 

Medsafe approves additional levothyroxine products

Media release

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.

Background

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

ENDS



© Scoop Media

 
 
 
Culture Headlines | Health Headlines | Education Headlines

 


Howard Davis Review: Ans Westra & The New Photography At Te Papa

Te Papa's latest exhibition and publication focuses its corrective lenses on eight outstanding photographic pioneers who forged a bold new style during the 1960s and 70s. More>>


Scoop Review Of Books: Making History

Jock Phillips is a pioneering public historian who has sought new ways to communicate history to a wide audience. His autobiographical memoir is a fascinating account of how perceptions of history have changed through his career. More>>

New Budget Arts Funding: Fairer Wage For Grant Artists, Creatives In Schools

The vital contribution and huge value the creative sector brings to New Zealand is recognised in this year’s Budget with $11.157 million over four years for two new initiatives, the Minister for Arts Culture and Heritage Jacinda Ardern said today. More>>

ALSO:

Auckland Region MMR Change: Children To Be Vaccinated For Measles At 12 Months

The first measles, mumps and rubella (MMR) vaccination has been brought forward to 12 months from 15 months in Auckland because of the region’s measles outbreak. More>>

ALSO:

Tapu Te Ranga: Fire Destroys Main Building At Island Bay Marae

There was a large fire at the Tapu Te Ranga Marae in Island Bay early Sunday morning. Firefighters saved the meeting house, but the main building collapsed in the blaze and other surrounding buildings were compromised. More>>

ALSO:

 
 
 
 
 

LATEST HEADLINES

  • CULTURE
  • HEALTH
  • EDUCATION
 
 
  • Wellington
  • Christchurch
  • Auckland