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Media statement - Eltroxin


Media statement - Eltroxin

11 September 2008

The Ministry of Health's drug regulatory arm Medsafe and Government drug-funding agency PHARMAC are well advanced in their efforts to source an alternative brand to the funded thyroid medicine Eltroxin.

Medsafe Group Manager Dr Stewart Jessamine says two separate applications to market other brands of levothyroxine have been received.

PHARMAC Funding and Procurement Manager Steffan Crausaz says PHARMAC will be able to give an update on funding an alternative within the next two weeks.

Since May of this year, when the numbers of adverse reactions to Eltroxin began to significantly increase, Medsafe has been contacting manufacturers and distributors of medicines encouraging them to submit an application for alternative brands of levothyroxine. "While any new products will still need to meet the required standards of safety, quality and efficacy before they can be approved, Medsafe will fast track the assessment of any applications it receives for levothyroxine to allow an approved alternative to be made available as promptly as possible,"Dr Jessamine said.

Steffan Crausaz says approval by Medsafe is only the first step in the process of making a funded alternative to Eltroxin available and PHARMAC expects to complete negotiations with at least one of the alternative medicine supply companies shortly.

PHARMAC has been holding discussions with suppliers in parallel with Medsafe's work, and once a medicine has Medsafe approval, PHARMAC is well placed to move quickly on funding, says Steffan Crausaz.

"We need to be assured that sufficient stock will be available, and to consult with suppliers and the public on the listing arrangements."

Dr Jessamine says in the meantime the advice received from specialist endocrinologists is that many of the adverse reactions are consistent with some patients absorbing lower amounts of levothyroxine from the new tablets. In their expert experience, blood tests to check the level of thyroid hormone stimulating hormone (TSH), and adjustment of the dose of Eltroxin, either to increase the dose (or in some cases to decrease it) will lead to resolution of the patients symptoms over a few weeks to months. Patients taking Eltroxin who are worried about the product, or who have already changed to other brands of unapproved levothyroxine, should contact either Healthline on 0800 611-116 or their doctor, as they may need ongoing thyroid blood monitoring and dose adjustment.

Dr Jessamine confirmed the results of independent testing of both the old and new formulation of Eltroxin by ESR indicate the new Eltroxin tablets are acceptably potent and do not contain unexpected or excessive impurity content, compared to the old formulation, and meet the requirements for dissolution (a marker for how quickly the products dissolve). The batches of products tested include samples obtained from a pharmacy and from Eltroxin manufacturer GlaxoSmithKline (GSK).

Dr Jessamine says some of the claims being circulated about the product are wrong, such as:
- it is not manufactured in India
- its manufacture does not involve any genetic engineering
- it does not contain MSG or any products not found routinely in other medicines.

The active ingredient (levothyroxine) in the new formulation is made in Austria by the same company, using the same method at the same site as the old formulation, and the finished product is manufactured in Germany. The other ingredients of the new formulation are routinely found in a range of other medicines and are not associated with increased rates of adverse effects.

The new GSK formulation of Eltroxin is currently marketed in close to 30 countries around the world. Medsafe has sought information from several of these countries where they have comparable adverse reactions reporting systems to New Zealand and it is clear they are not receiving increased numbers of reports for the new formulation product.

Medsafe also asked each of the 83 countries who make up the World Health Organisation Adverse Reactions Reporting System for any information they had on increased rates of reporting to GSK Eltroxin, or to adverse reactions following switches to brands of levothyroxine. The only positive feedback received came from the United Kingdom and Australia, countries where the GSK brand of Eltroxin is not available, who reported that they have small numbers of reports of adverse reactions that are similar in nature to those received in New Zealand but associated with patients shifting between different brands of levothyroxine.

While most patients (approx 99%) continue to have no major problems with the GSK Eltroxin, many of the side effects reported by the 800 individuals who have submitted reports to the New Zealand Pharmacovigilance Centre would be explained by changes in how these individuals absorb, metabolise or excrete the new formulation of Eltroxin compared to the old product.

Dr Jessamine says that while changing to a new levothyroxine product may resolve some of the problems where the person is allergic to, or intolerant of, the new formula of Eltroxin, patients will still need to have their blood tests monitored and it is quite likely that they will need to have the dose of any new brand of product adjusted to suit their individual metabolism. If patients wish to avoid adverse effects associated with increased or decreased thyroid activity that can occur following a switch in brands, so careful monitoring and dosage is essential.

For more information contact:
PHARMAC Communication Manager Simon England 021-863-342
Ministry of Health Media Advisor Michael Flyger 027-434-6878

BACKGROUND

Hypothyroidism
Thyroid medicines contain the active ingredient levothyroxine – a thyroid hormone.

Levothyroxine is used to treat hypothyroidism, a disease in which the thyroid gland is underactive and does not produce enough thyroxine, a hormone, which is important for controlling your metabolism.

Symptoms of hypothyroidism include tiredness, muscle weakness, cramps, feeling the cold, a slow heart rate, dry and flaky skin, hair loss, a deep husky voice and weight gain.

Children and elderly people usually need a smaller dose because they are more sensitive to the effects of levothyroxine.

Many people need treatment with levothyroxine long term.

Levothyroxine is produced in tablet form. Tablets are swallowed whole with a glass of water. Tablets are taken on an empty stomach, 30 minutes before breakfast.

Rare reactions to levothyroxine include:

Diarrhoea
Vomiting
Palpitations (irregular heartbeat)
Chest pain
Sweating/flushing
Weight loss
Muscle weakness/cramps, tremors
Rapid breathing
Fever
Headache
Inability to sleep
Feeling restless/excited


Many of these side effects often disappear when the dose is adjusted (lowered).

Patient advice:
Medsafe advises patients taking thyroxine to follow the dose instructions carefully and to contact their pharmacist or GP to discuss any concerns or questions they may have about this medicine.

Medsafe encourages GPs and pharmacists to review how patients are taking this medication, to monitor the effects of the change to the new formulation and to report any side effects, including problems with maintaining adequate control of hypothyroidism, to the New Zealand Pharmacovigilance Centre at the University of Otago. It is important that patients who report any adverse effects have their blood tests checked at the time of reporting. Most reports received so far have not included information about blood test results.

Although the new formulation of Eltroxin has been approved as safe and effective by Medsafe; prescribers, pharmacists and patients need to bear in mind that each individual may respond differently to the new formulation and that patients taking it should be monitored by a health professional and dose adjustments made if necessary. Patients should also make sure they are taking their medication on an empty stomach and are taking whole tablets in accordance with the advice from their GP.

The Medsafe data sheet on Eltroxin is available here:

http://www.medsafe.govt.nz/Profs/Datasheet/e/Eltroxin(new)tab.htm

Testing
Testing by ESR has confirmed that Eltroxin contains nothing other than ingredients specified on the label:
Levothyroxine sodium hydrate
Magnesium stearate
Microcrystalline cellulose
Pregelatinised maize starch
Purified talc
Silicon dioxide

GSK no longer manufactures the formulation of levothyroxine previously sold in NZ, and no changes in formulation are planned.

The GSK brand of levothyroxine has been the only brand of product available and supplied in New Zealand for a number of years.

Prescribers can source thyroxine medicines direct from overseas under an exemption of the Medicines Act, but the medicines sourced this way have not been assessed or funded and require informed consent from patients.


ENDS

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