MHRA suspends Teva licence for levothyroxine generic
pharmafile | February 21, 2012 | News story | Manufacturing and Production |Â Â MHRA, Numark, Teva, levothyroxineÂ
The UK medicine regulatory authority has suspended the licence for a levothyroxine product sold by Teva on the grounds that it may not be interchangeable for other products used to treat hypothyroidism.
The Medicines and Healthcare products Regulatory Agency (MHRA) said that the 100mcg tablet formulation of levothyroxine may have dissolution issues, caused by manufacturing difficulties, which could affect the release of the active ingredient.
“This may lead to a loss of control of hypothyroidism when switching between products,” it said in a statement, noting that supplies of the product will be phased out in the coming weeks as stocks are exhausted.
Packs sold under the license will bear either Teva or Numark branding, according to the agency. Other dose strengths – 25mcg and 50mcg – are not affected.
The decision to suspend the licence came on the back of a review by the MHRA’s independent advisory body, the Commission on Human Medicines (CHM), which examined both the manufacturing issues and hypothyroidism reports.
“While it cannot conclusively be said that these issues prove Teva tablets are not interchangeable with other makes of levothyroxine 100mcg tablets, the MHRA has taken prompt action as a precautionary measure,” it said.
Teva has already said that it has voluntarily stopped manufacturing and distributing the affected dosage form and was trying to identify the cause of the problem.
Patients already taking the Teva or Numark products should continue using their current supply until it is exhausted, unless they start to feel unwell or are in a group known to be susceptible to changes in thyroid hormone levels, such as pregnant women, those with heart disease and those under treatment with levothyroxine following treatment for thyroid cancer.
Other companies selling levothyroxine 100mcg tablets in the UK include Actavis, Forley Generics and Goldshield.
Phil Taylor
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