In November 2018, the following letters were sent to healthcare professionals:
Drug alerts and recalls
In November 2018, MHRA issued the following Alerts and recalls for drugs:
Recall of some valsartan-containing products
You should also be aware of a European-level recall from pharmacies of certain batches of Teva valsartan-containing products and all unexpired Mylan valsartan-containing products as a precautionary measure due to possible contamination with NDEA. See the recall notice on the MHRA website (issued 30 November 2018).
Advice for healthcare professionals:
- stop supplying the affected products/batches listed immediately; quarantine all remaining stock and return it to your supplier using your supplier’s approved process
- advise patients not to stop taking their medication as the risk of discontinuing the medicine is higher than the potential risk presented by the contaminant. A treatment review is not necessary until the next routine appointment.
- although shortages of valsartan-containing products are not anticipated, there may be some local supply issues – should this be the case, patients should be advised to speak to their doctor to discuss alternative treatments
This is a developing issue and the MHRA is actively involved with the European Medicines Agency and with other medicines regulators to determine any possible impact. An investigation into other potentially impacted products is continuing and further updates will be provided as the investigation progresses. Subscribe to MHRA drug alerts for updates.
Article citation: Drug Safety Update volume 12, issue 5: December 2018: 6.
Published 18 December 2018