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Teva levothyroxine questions and answers - levothyroxine side effects


Teva levothyroxine questions and answers -levothyroxine side effects

Teva levothyroxine questions and answers
1. Why are Teva levothyroxine 100mcg tablets being withdrawn?
MHRA has received sporadic reports from prescribers and patients, which have increased in
Dec 2011 / Jan 2012, raising concerns about the interchangeability of this product with other
makes of levothyroxine 100 mcg tablet.
Some patients have experienced a loss of control of thyroid stimulating hormone (TSH)
levels when switching between Teva Levothyroxine tablets and other Levothyroxine
products. The manufacturer, Teva, has also been experiencing difficulties in manufacturing
this product. Results of tests conducted by the MHRA's Medicines Testing Laboratory,
suggest that the TEVA product may differ from other products in the amount of levothyroxine
that is released over time (dissolution). While it cannot conclusively be said that these issues
prove Teva tablets are not interchangeable with other makes of levothyroxine 100 mcg
tablets, the MHRA has taken prompt action as a precautionary measure. The MHRA has
suspended the manufacture and distribution of Teva tablets having obtained advice from an
independent panel of experts, the Commission on Human Medicines (CHM).
Many patients changing to or from the Teva product will not experience any changes in their
symptoms. However, there are some patient groups where control of thyroid function is
particularly important. These subgroups of patients are:-
Pregnant women, throughout pregnancy but especially in the first 3 months of pregnancy
(first trimester)
Those with heart disease
Those under treatment with TSH suppressive doses of levothyroxine following treatment for
thyroid cancer
Patients in these groups taking the Teva or Numark Levothyroxine 100 mcg Tablet product
should make an early appointment with their doctor.
2. Which levothyroxine products are affected?
Only Levothyroxine 100 mcg tablets that are supplied in the Teva and Numark liveries are
affected. The product will bear the Marketing Authorisation number, PL 00289/0039.
Levothyroxine products from other manufacturers are unaffected by this suspension
3. Are the TEVA and Numark levothyroxine 100 mcg tablets identical?
Yes, they are identical apart from the packaging.
4. What other makes of levothyroxine 100mcg tablets are available?
A list of manufacturers and suppliers of Levothyroxine 100mcg Tablets is given below:
Product Licence Product Marketing Distributed by
(PL) Number as Name/Brand as Authorisation
stated on the stated on the label (MA) Holder
label and patient and patient leaflet
leaflet
PL 00142/0105 THYROXINE Actavis UK Almus, or
TABLETS BP 100 Limited Actavis, or
MICROGRAMS Lloyds
PL 16201/0002 LEVOTHYROXINE Forley Generics Forley Generics
100micrograms Limited Limited
Tablets
PL 10972/0032 ELTROXIN Goldshield Group Goldshield
TABLETS Limited Group Limited
100MCG
5. Are all patients that are taking levothyroxine affected?
Patients who are taking tablets of 50 mcg or 25 mcg are not affected. Patients who are
taking doses of 100mcg or more, are only affected if they are taking a Teva (or Numark)
levothyroxine 100mcg tablet.
6. Why do the Teva 100mcg tablets continue to be available over the next few
weeks?
Most patients taking Teva levothyroxine tablets will continue to feel well. Levothyroxine is an
essential medicine and it is important that the suspension of the Teva product does not
create a shortage with patients being unable to fulfil their prescription. It will take a few weeks
before other suppliers have built up stocks of this medicine. .
7. Can I use up my existing Teva 100mcg tablets or should I ask my doctor to
change them?
Most patients will not feel any different by continuing with their medication and changing to a
different levothyroxine product at their next prescription. Blood test results will then allow any
dose adjustment.
8. I have been taking Teva levothyroxine 100mcg tablets for some time. What
advice can you give me? Will I be able to obtain further supplies?
Patients who have been taking Teva levothyroxine for some time would be stabilised on this
product and feel well. However because of the concerns raised about the interchangeability
of this product compared with other levothyroxine tablets, no further supplies of the product
will be released for marketing and the tablets will not be available until these issues have
been resolved.
Unless you are in the groups of patients described in Q&A no. 1, you should continue to take
your Teva tablets and change to a different levothyroxine product at your next prescription. It
should not be necessary to make an early appointment with your doctor. Most patients are
unlikely to notice any change if they are switched from the Teva product to another
Levothyroxine product, however if you start to feel unwell then you should see your doctor.
9. What should I do if I feel unwell when I change from Teva tablets to a
different brand at my next prescription?
Most patients are unlikely to notice any change if they are switched from the Teva product to
another levothyroxine product. However, if you start to feel unwell then you should see your
doctor. You may not notice any changes for 4-6 weeks after switching to a different brand.
10. Will my levothyroxine dose need to be changed if I switch to or from the
Teva make?
It is possible that your dose of levothyroxine will need adjustment. If you feel unwell, then
you should see your doctor who will check whether a dose adjustment is needed. You may
not notice any symptoms until within 4-6 weeks after changing from the Teva tablets to
another make.

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