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