The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for September 2014 (PDF).
The drug safety section in this issue advises clinicians about updated recommendations to reduce the risk of osteonecrosis of the jaw (ONJ) associated with use of denosumab (Prolia® and Xgeva®). Dental examination and appropriate preventive dentistry are now recommended prior to initiating treatment to reduce the risk for both indications (osteoporosis and cancer).
This section also advises that nitrofurantoin now contraindicated in most patients with an estimated glomerular filtration rate (eGFR) of less than 45 ml/min. However, it can be used in patients with an eGFR of 30 to 44 ml/min to treat lower urinary tract infection with suspected or proven multidrug resistant pathogens when the benefits of nitrofurantoin are considered to outweigh the risks of side effects. This contraindication allows nitrofurantoin to be used in patients for whom it was previously not recommended. A renal function check should also be considered when choosing to treat with nitrofurantoin, especially in the elderly.
The yellow card scheme update advises clinicians that new guidelines for reporting suspected adverse drug reactions (ADRs) in children and adolescents aged under 18 years have been published. Previously, reporting was requested for all ADRs however it is now advised that yellow cards should be completed for:
- all suspected ADRs that are serious or result in harm. Serious reactions are those that are fatal, life-threatening, disabling or incapacitating, those that cause a congenital abnormality or result in hospitalisation, and those that are considered medically significant for any other reason.
- all suspected ADRs associated with new drugs and vaccines (identified by the black triangle symbol: ▼)
The stop press section reminds clinicians that domperidone is no longer available to purchase in pharmacies.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
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