The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for May 2014 (PDF).
This issue contains drug safety advice informing clinicians that use of domperidone is now restricted to the relief of nausea and vomiting and the dosage and duration of use have been reduced following continued reports of cardiac side effects. Concerns were first raised two years ago. It is now recommended that domperidone is used at the lowest effective dose for the shortest possible time and avoid in patients at higher risk of cardiac side effects including those with existing cardiac conduction conditions, impaired liver function or taking medication that may interact with domperidone.
This section also advises that people who have been prescribed an adrenaline auto-injector because of the risk of anaphylaxis should carry two with them at all times for emergency, on-the-spot use. After every use of an adrenaline auto-injector, an ambulance should be called (even if symptoms are improving), the individual should lie down with their legs raised and, if at all possible, should not be left alone.
The hot topic section contains a detailed review of the risk and benefits of statin treatment. This information presented may be useful when discussing statin treatment with patients, especially following the retraction of some articles in the BMJ that exaggerated concerns over side effects.
The stop press section notes that zolpidem is associated with a risk of impaired driving ability the next day. Zolpidem is recommended for short term use only for severe insomnia and reduced doses are recommended for people with liver impairment and the elderly. To minimise the risk patients are advised:
- to take 10 milligrams of zolpidem at bedtime and not to take it again the same night
- not to drive, operate machinery, or work at heights until at least 8 hours after taking zolpidem
- not to take zolpidem with alcohol, illicit drugs, or other central nervous system suppressants
- not to drive, operate machinery or work at heights if they are still drowsy after taking zolpidem
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.