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MHRA suspends license of Teva generic over dissolution fears

By Nick Taylor , 20-Feb-2012

The MHRA has suspended the license for a Teva generic over suggestions its dissolution rate could affect interchangeability.

Teva has voluntarily stopped manufacture and distribution of the product, levothyroxine 100mcg tablets, after the UK Medicines and Healthcare products Regulatory Agency (MHRA) suspended its license.

The MHRA wrote: “Teva has 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.”

Some patients have “experienced a loss of control of thyroid stimulating hormone (TSH) levels” when switching between levothyroxine sold by Teva and other manufacturers. This is insufficient evidence to prove that the Teva product lacks interchangeability, but is enough for MHRA to take precautions.

Most patients should continue taking the Teva product until their next prescription. The exceptions are pregnant women, those with heart disease, and patients receiving suppressive doses of levothyroxine following treatment for thyroid cancer.

Switching supply

The suspension of the license will last until “Teva has completed its investigation and resolved the underlying issues”, the MHRA wrote. Levothyroxine 100 mcg tablets in Numark packaging are the same product as the Teva branded version and are also affected by suspension of the license.

Actavis, Forley Generics, and Goldshield Group also sell levothyroxine 100mcg tablets in the UK. The MHRA said it will take “a few weeks” for other supplier to build up stocks and it is important to avoid a drug shortage situation.

In-PharmaTechnologist contacted a Teva spokesperson by email for a statement but was yet to receive a response at the time of publication.

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