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

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The MHRA and CHM have published the latest issue of Drug Safety Update (3rd December 2007).

This contains information on several topics, including:

  • Recombinant human erythropoetins – New prescribing advice has been issued following evidence that overcorrection of haemoglobin in patients with chronic kidney disease may increase the risk of death and serious cardiovascular (CV) events, and in patients with cancer may increase the risk of thrombosis and related complications.

  • Rosiglitazone and pioglitazone – The CV safety of these drugs is summarised. Neither drug should be used in patients with heart failure or a history of heart failure, and rosiglitazone should only be used in patients with previous or current ischaemic heart disease (IHD) after careful evaluation of the patient’s individual risk (see NPC rapid reviews November 19th 2007 and October 25th 2007).

  • Dosulepin – Due to concerns over the toxicity of dosulepin, measures have been introduced to reduce the risk of fatal overdosage. Use in new patients should be avoided and, if dosulepin is considered necessary, it should only be initiated by a specialist.

  • ACE inhibitors and angiotensin II receptor antagonists (A2RAs) – These should not be used at any stage of pregnancy and only if absolutely necessary in those women planning to become pregnant. Observational data shows that ACE inhibitors may increase the risk of congenital malformations. There are fewer data available for A2RAs and a similar risk cannot be excluded.

  • Short-acting beta-agonists – These may cause myocardial ischaemia and should not be used to manage premature labour in patients with IHD or risk factors for CV disease. Patients with a history of heart disease who are receiving short-acting beta-agonists for respiratory disease should be advised to seek medical advice if symptoms such as shortness of breath or chest pain occur.

There is also information and advice on other topics, including possible adverse effects of varenicline▼ and the CV and gastrointestinal toxicity of NSAIDs and coxibs (see MeReC Extra No.30, the related blog on this as well as the extensive additional resources).

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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