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

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11th July 2008

The MHRA and CHM have published the latest issue of Drug Safety Update (7th July 2008). There is drug safety advice for varenicline▼ and bisphosphonates; a hot topic article on inhaled corticosteroid products, and stop press articles about storage of rotigotine▼ patches, enoxaparin contamination and new warnings and contraindications relating to ergot-derived dopamine agonists, etoricoxib▼ and epoietins.

Drug Safety Update highlights the following points

Varenicline▼ – suicidal thoughts and behaviour:-

  • Suicidal thoughts and behaviour have been reported in users of varenicline▼ who have no known pre-existing psychiatric conditions, and while they continue to smoke. Patients should be told to stop treatment and contact their doctor immediately if they develop suicidal thoughts or behaviour. Varenicline▼ should be stopped immediately if agitation, depressed mood, or changes in behaviour are observed that are of concern to the patient, family, or caregivers. The safety and efficacy of varenicline▼ in people with serious psychiatric illness have not been established: patients who have a history of psychiatric illness should be monitored closely while taking varenicline▼.
  • Varenicline▼ has previously been mentioned in Drug Safety Update in December 2007 and February 2008. The MHRA/CHM ask health professionals to report  all reactions that they suspect may be related to the use of varenicline▼ — including any considered not to be serious and reactions that are well-recognised.  “You do not have to be certain about causality,” they say, “if in doubt, please report.”

Inhaled products that contain corticosteroids:-

  • A hot topic article summarises licensed doses, differences in potency between products, and their use with spacer devices.

Bipshosphonates: atrial fibrillation:-

  • Clinical trial results have suggested an increased risk of atrial fibrillation for zoledronic acid▼, pamidronic acid, and possibly for alendronic acid. The risk of atrial fibrillation in association with bisphosphonate treatment seems to be low, and the balance of risks and benefits for bisphosphonates remains favourable.
  • The product information for zoledronic acid has been updated to include atrial fibrillation as a possible side-effect (both for Aclasta▼ and Zometa® (a product that contains zoledronic acid that is given every 3–4 weeks as part of cancer treatment). Atrial fibrillation is also being added to the product information for pamidronic acid. The risk of atrial fibrillation with alendronic acid will be kept under close review. Should further evidence accumulate, the product information for alendronic acid will be updated accordingly

Drug Safety Update also contains advice about new prescribing and storage requirements for rotigotine▼ (Neupro®), a transdermal patch that is indicated for use in Parkinson’s disease. It also highlights further information about the supply and prescribing of enoxaparin (Clexane®) published on 6th June 2008 (see also clarification, published 11th June 2008. Finally, Drug Safety Update highlights recent EMEA advice about etoricoxib▼, epoietins and ergot-derived dopamine agonists, about which we have recently blogged.

Drug Safety Update is an essential read for everyone whose professional practice involves medicines. It replaces Current Problems in Pharmacovigilance, and is published every month in electronic format only.

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