Copies of letters sent to healthcare professionals in October 2014, to inform of new safety information and advice.

Date sent Medicine Safety information

1 October 2014

SonoVue (sulphur hexafluoride)PDF file (opens in new window)(1582Kb)

If a patient has cardiovascular instability (eg recent acute coronary syndrome or clinically unstable ischaemia), administer SonoVue with extreme caution and only after carefully considering the balance of benefit against risks. Closely monitor vital signs during and after administration: in these patients, allergy-like or vasodilatory reactions may lead to life-threatening conditions.

Do not use SonoVue in combination with dobutamine in patients with conditions suggesting cardiovascular instability. Rare but severe arrhythmias, sometimes fatal, have been reported in patients with cardiovascular instability during stress echocardiography procedure with SonoVue used in combination with dobutamine.

7 October 2014

Piportil Depot (pipotiazine palmitate)PDF file (opens in new window)(1547Kb)

The following Piportil Depot® formulations will no longer be available from the end of March 2015:

  • Piportil Depot® (Pipotiazine palmitate) 10 x 1ml (50mg/ml) amp
  • Piportil Depot® (Pipotiazine palmitate) 10 x 2ml (50mg/ml) amp

Do not start new patients on pipotiazine palmitate. Switch patients currently prescribed pipotiazine palmitate to alternative treatments.

17 October 2014

OncoTICE (attenuated bacilli of Mycobacterium bovis, prepared from a culture of Bacillus Calmette-Guérin

[BCG]PDF file (opens in new window)(290Kb))

There is a supply shortage of OncoTICE in the UK. As an interim measure, a batch which was packaged for a different country has been made available to the UK. This batch does not contain a Patient Information Leaflet (PIL) in the pack. Copies of the PIL are being distributed along with the ordered batches. Please ensure that patients have access to these PILs.


Posted on the UK MHRA website on 17 November 2014