In the wake of a growing number of complaints about side-effects of a thyroid treatment drug, the Ministry of Health has approved two alternatives.
Medsafe, the ministry's unit responsible for regulating drugs, has given provisional approval to two products containing levothyroxine, giving patients in New Zealand 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.
About a year after its introduction, the numbers of people suffering side effects from Eltroxin increased. The levothyroxine drug is is used to treat hypothyroidism, is a disease where the thyroid gland doesn't produce enough thyroxine, a hormone important to controlling the body's metabolism.
In July last year GlaxoSmithKline, the company producing Eltroxin, announced that this government-subsided drug had undergone a formulation change.
Essentially, its shape, size and colour were changing but nothing else.
As with all drugs Eltroxin had its side effects. But soon after the change was announced, reports about side effects started arriving at the Centre for Adverse Reactions Monitoring at the NZ Pharmacovigilance Centre at the University of Otago. What began as a trickle of reports from people about the drug's side effects has turned into a flood.
With the alternative drugs now available, Medsafe said each company will be required to notify prescribers and pharmacists of the increased need to closely monitor patients who switch brands.
Dr Stewart Jessamine, Medsafe group manager said they were satisfied with their evaluations and that both Levothyroxine and Synthroid were safe and effective alternatives to Eltroxin.
But Dr Jessamine said both products would be carefully monitored.
"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," he said.
The Goldshield brand will be fully funded from November 1, and full funding will remain for the existing Eltroxin. But Pharnmac said full funding for Synthroid would not be available at this time, however funding may be possible in the future.
Ministry approves alternatives to problem thyroid drug
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