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Drug Safety Update – February 2010

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for February 2010 (PDF).

This issue contains drug safety advice informing clinicians about a new oral liquid formulation of tacrolimus (Modigraf®) with particular attention drawn to the requirement of careful monitoring if switching formulation.

The Yellow Card update section notifies readers of a recent issue identified within the Royal Mail where some cards have been returned to the sender. If you have had a card returned, or if you have submitted a card and not received an acknowledgement letter, you should resubmit the report.

This section also contains a review of the reporting information for swine flu vaccines and antiviral medication. The safety profile is reassuring since the "number and the nature of suspected adverse effects reported are very much as we expected at this stage in the immunisation campaign".

The Hot Topic section provides an update on safety information for orlistat (Xenical® and Alli®) including to some potential drug interactions with levothyroxine and antiepileptic agents. This section also informs readers of the license extension for nicotine replacement therapy (NRT) products to include harm reduction as it is now widely accepted that there are no circumstances in which it is safer to smoke than to use NRT.

Finally, the Stop Press section reminds readers of the recent withdrawal of sibutramine (Reductil®) after a review identified that the cardiovascular risks of treatment outweigh its benefits.

Action: Clinicians will find this publication to be a useful review of current issues in drug safety.