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Thread: MHRA suspends licence for Teva levothyroxine 100 microgram tablets

  
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    Info MHRA suspends licence for Teva levothyroxine 100 microgram tablets

    Sad news as quite a few people use Teva Thyroxine in the UK but it does show you how different brands vary amount of thyroxine in their tablets.

    The Medicines and Healthcare products Regulatory Agency (MHRA) has suspended the licence of levothyroxine 100 microgram tablets, manufactured by Teva, for patients with hypothyroidism. This follows manufacturing difficulties and concerns that the product might not be interchangeable with other available levothyroxine 100 mcg tablets. This may lead to a loss of control of hypothyroidism when switching between products.

    Only levothyroxine 100 mcg tablets supplied in the Teva and Numark brands are affected. As this medicine is a generic, alternative products are available and most patients are unlikely to notice any change if they are switched from the Teva product to another levothyroxine product.Teva levothyroxine 100 mcg tablets will cease to be available in the UK within the next few weeks as stocks are exhausted.




    The decision to suspend follows a review by the Commission on Human Medicines (CHM), the MHRA’s independent advisory body, of manufacturing issues and sporadic reports of loss of control of hypothyroidism when switching between products. As a precautionary measure, whilst investigations are ongoing, Teva has voluntarily ceased manufacture and distribution in line with the CHM recommendation.


    The CHM review concluded that it might not be possible to switch use of the Teva product with other levothyroxine products, and that no further supplies of the product should be released for marketing until these issues are resolved.

    If patients feel unwell taking the Teva levothyroxine tablets they should report them to their healthcare professional because adjustments to the dose of levothyroxine may be required.


    The following patients may be particularly susceptible to changes in thyroid stimulating hormone (TSH) and may require close monitoring by their doctor: pregnant women, those with heart disease and those under treatment with levothyroxine following treatment for thyroid cancer. For those patients an early appointment with their doctor may be needed.


    After dose adjustment of levothyroxine, consistent with usual practice, TSH should be retested after a period of six weeks to confirm blood levels are stabilised within the normal range as determined by their doctor.


    The suspension will remain in place until Teva has completed its investigation and resolved the underlying issues.

    Further information is published in a questions and answers document (47Kb) on the MHRA website:

    http://www.mhra.gov.uk/home/groups/comms-po/documents/news/con143690.pdf


    Original press release in PDF format here:

    http://www.mhra.gov.uk/home/groups/comms-po/documents/news/con143689.pdf

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    GENERIC NAME: levothyroxine sodium

    BRAND NAME: Synthroid, Levoxyl, Levothroid, Unithroid

    DRUG CLASS AND MECHANISM: Levothyroxine is a synthetic (man-made) version of the principle thyroid hormone, thyroxine (T4) that is made and released by the thyroid gland. Thyroid hormone increases the metabolic rate of cells of all tissues in the body. In the fetus and newborn, thyroid hormone is important for the growth and development of all tissues including bones and the brain. In adults, thyroid hormone helps to maintain brain function, food metabolism, and body temperature, among other effects.

    GENERIC AVAILABLE: Yes. Generic and branded tablets of levothyroxine may differ:

    • in the amount of levothyroxine they contain,
    • the absorption of the levothyroxine into the body, and
    • the distribution of levothyroxine throughout the body.


    This means that ingestion of 1 mg of generic levothyroxine may not have the same effect on the body as 1 mg of another generic or branded levothyroxine. Practically speaking, this means that when changing between levothyroxine manufactured by different pharmaceutical companies, a change in dose may be necessary to maintain the desired effect, or to prevent toxicity.

    Seems like it's quite for different brands of thyroxine to contain different amount of thyroxine

 

 

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