Teva levothyroxine 100 microgram tablets: suspension of marketing authorisation
- Medicines and Healthcare products Regulatory Agency
- 11 December 2014
- Therapeutic area:
- Endocrinology, diabetology and metabolism
Following a review by the Commission on Human Medicines (CHM), the marketing authorisation (licence) for levothyroxine 100 microgram tablets manufactured by Teva has been suspended.
This article has been superseded. Please see updated information on the re-entry to market and introduction of new tablet strengths for Teva levothyroxine, October 2016.
Article date: March 2012
Following a review by the Commission on Human Medicines (CHM), the marketing authorisation (licence) for levothyroxine 100 microgram tablets manufactured by Teva has been suspended. The CHM review examined sporadic reports of potential reduced efficacy when switching to Teva levothyroxine from other levothyroxine products and evidence of manufacturing difficulties.
As a precautionary measure while investigations are ongoing, Teva has ceased manufacture and distribution of levothyroxine 100 microgram tablets. Only the Teva and Numark brands of this product are affected by the suspension.
Teva levothyroxine 100 microgram tablets will cease to be available in the UK within the next few weeks, and no further supplies of this product will be released for marketing. Teva is accepting returned stock via the normal channels if it is not required to meet patient needs*. Other levothyroxine 100 microgram products will continue to be available.
Advice for healthcare professionals:
- prescribers should be alert to the possibility that a change in a patient’s symptoms and TSH status may be attributed to switching to Teva product from another levothyroxine product
- certain patient groups such as pregnant women, patients with heart disease, and patients receiving treatment with levothyroxine following treatment for thyroid cancer should be monitored closely. If taking Teva tablets, they should have an early appointment with their doctor for a clinical review and blood test
- the majority of patients will be able to continue with their medication and change to a different levothyroxine product at their next prescription
- patients who experience a significant change in symptoms especially after switching should have their TSH status reviewed and their dose of levothyroxine adjusted accordingly
- you can report suspected lack of efficacy on a Yellow Card (www.mhra.gov.uk/yellowcard)
*Please liaise with your wholesaler or arrange for uplift via Teva’s Customer Liaison team (0800 590 502) in the usual manner if you wish to return the Teva /Numark levothyroxine 100 microgram packs.
Central Alerting System alert for the suspension of Teva levothyroxine 100 microgram tablets (issued 16th February 2012)
MHRA press release on suspension of Teva levothyroxine
Q&A document on Teva levothyroxine suspension
Article citation: Drug Safety Update March 2012, vol 5 issue 8: S1.
Published: 11 December 2014
Therapeutic area: Endocrinology, diabetology and metabolism