NPC Archive Item: Drug Safety Update from MHRA/CHM

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The MHRA and CHM have published the latest issue of Drug Safety Update (6th May 2008)

Drug Safety Update highlights the following points

  • Rimonabant▼: depression and other psychiatric adverse reactions. Depressive reactions may occur in up to 10% of patients treated with rimonabant.  Rimonabant is contraindicated in patients with ongoing major depression or those taking antidepressants. Prescribers are encouraged to take a detailed history from patients before prescribing rimonabant to assess risk factors for psychiatric reactions, particularly depression. However, depressive reactions may occur in patients who have no obvious risk factors, apart from obesity itself.

The psychiatric side effects of rimonabant have been discussed in more detail in a previous blog and the March edition of MeReC Extra, No 32. Final guidance from  NICE is expected towards the end of May 2008, and should be referred to once available.

  • Exenatide: risk of acute pancreatitis. Spontaneous reports of acute pancreatitis have been received in association with exenatide. Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain; back pain may also be present.  If pancreatitis is suspected, exenatide and other potentially suspect medicines should be discontinued.

Drug Safety Update also draws attention to the MHRA’s pregnancy testing: top tips leaflet. This is intended to help ensure best practice for pregnancy testing by healthcare professionals. The leaflet may be of particular interest to point-of-care coordinators, GPs, pharmacists and others who provide a pregnancy testing service.

Drug Safety Update also highlights the results of the D:A:D study (Data collection of Adverse effects of anti-HIV Drugs) and the need for ongoing reporting of suspected adverse reactions to anti-retroviral drugs through the Yellow Card scheme.  There is also  information about the problem of contaminated clexane, about which we have previously blogged, and the increased risk of inflammatory mass formation in patients with implantable intrathecal drug pumps.

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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