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

NOTE – This is an archive post from the NPC and has not been updated since first publication. Therefore, some hyperlinks may no longer be working.
merec_stop_press NPC Logo

NHS Evidence accreditation logo The Drug Safety Update is an NHS Evidence accredited provider

The MHRA and CHM have published the latest issue of Drug Safety Update (7th January 2008).

This contains information on several topics, including:

  • Long-acting beta2 agonists (LABAs) for asthma (see separate blog)

  • Statins: interactions, and updated advice for atorvastatin

Drug interactions may increase the risk of adverse effects, or reduce the effectiveness of statin treatment. Updated prescribing advice for atorvastatin provides detailed recommendations for dose restrictions when used with some other drugs. You can find more information about statins on the lipids section of NPC

  • Desmomelt (desmopressin): call for Yellow Card reporting

The primary nocturnal enuresis (PNE) indication has been removed from all desmopressin nasal spray products because of an increased risk of hyponatraemia compared with the oral formulation (which remains available for treatment of PNE, along with the melt formulation). Healthcare professionals are encouraged to report all suspected adverse reactions to melt formulations of desmopressin

  • Methylthioninium chloride (methylene blue): CNS toxicity with serotonergic drugs

Methylthioninium chloride (methylene blue) in high intravenous doses should preferably be avoided for patients who are receiving serotonergic drugs (eg SSRI antidepressants, clomipramine, and venlafaxine)

  • Bivalirudin▼: risks associated with incorrect dose

The approved dosing regimen for bivalirudin should be used in percutaneous coronary intervention (PCI). Use of a maintenance infusion after an initial bolus is necessary to ensure adequate anticoagulation during PCI.

There is also information and advice on other topics, including a plan to withdraw carisoprodol (a treatment for short-term symptomatic relief of muscle spasm) from the market following an EMEA review; the fire risks of paraffin-based topical treatments; and the risks of incorrect dosing of oral anticancer agents

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.

Please comment on this blog in the NPC discussion rooms, or using our feedback form.