Letters and drug alerts sent to healthcare professionals in November 2018

A pharmacy-level recall of some valsartan-containing products took place due to possible contamination, including advice to healthcare professionals and information on supply. Letters were also sent about quadrivalent influenza vaccines and systemic and inhaled fluoroquinolones and an alert was issued about Mitomycin-C Kyowa.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 18 December 2018

• Therapeutic area: Cancer, Cardiovascular disease and lipidology, Immunology and vaccination and Infectious disease

Letters

In November 2018, the following letters were sent to healthcare professionals:

• Supply of Standard Export pack of Quadrivalent Influenza Vaccine (split virion, inactivated) suspension for injection in a prefilled syringe PL 46602/0017 - Lot R3K781V, Expiry 31/08/2019

• Systemic and inhaled fluoroquinolones: risk of aortic aneurysm and dissection

Drug alerts and recalls

In November 2018, MHRA issued the following Alerts and recalls for drugs:

• Mitomycin-C Kyowa: Company-led Drug Alert. Issued 12 November 2018. Batch Number 6058517 is being recalled because an out-of-specification result for sub-visible particles was recorded at the 39-month time-point.
• Class 2 Medicines Recall: Teva UK Limited and Mylan - recall of some Valsartan containing products. Issued 30 November 2018 – see below for more.

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