NPC Archive Item: February Drug Safety Update from MHRA/CHM

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The MHRA and CHM have published the latest issue of Drug Safety Update (4th February 2008).

This contains information on several topics, including:

  • Statins: Several additional adverse effects of statins as a class have been identified including sleep disturbances, memory loss, sexual dysfunction, depression and interstitial lung disease. Product information for all statins is being updated. The benefits of statins still outweigh the risks for the majority of patients, as discussed on the CV risk lipids section of NPC.

  • Varenicline: As reported in a previous blog, varenicline has been associated with depression, including suicidal thoughts and behaviour. Following a Europe-wide review prescribing advice has been issued, including recommendations that patients who are taking varenicline who develop suicidal thoughts should stop the treatment and contact their doctor immediately.

  • Carisoprodol: A European review has concluded that the risks of treatment with carisoprodol outweigh the benefits and its Marketing Authorisation is being suspended. A phased withdrawal will be undertaken in the UK. A similar withdrawal of meprobamate is also being considered.

  • Duphaston and Duphaston HRT: These products are being withdrawn from the market for commercial reasons in March 2008.

  • Rosiglitazone: A European assessment has recommended new contraindications and warnings for rosiglitazone. It is now contraindicated in patients with acute coronary syndrome and is also not recommended for use in patients with ischaemic heart disease or peripheral arterial disease. We have previously addressed cardiovascular safety concerns with the glitazones in this blog.

Notes about Drug Safety Update

Drug Safety Update is an essential read for everyone whose professional practice involves medicines.

Drug Safety Update replaces Current Problems in Pharmacovigilance, the last issue of which was produced in May 2006. Drug Safety Update is published every month. A copy of Current Problems used to be sent to all doctors, dentists, pharmacists and coroners in the United Kingdom but paper copies of Drug Safety Update will not be posted to any group of clinicians.

If you would like to receive an e-mail notification when new issues of ‘Drug Safety Update’ are published, please subscribe to the MHRA’s free e-mail alerting service.

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