UK MHRA Drug Safety Update (Volume 8, Issue 2)

Drug safety advice

 

• Ferumoxytol: risk of serious hypersensitivity reactions—contraindicated if any drug allergy; administer via infusion  

New recommendations are being introduced to minimise the risk of serious hypersensitivity reactions with ferumoxytol. These include a contraindication in patients with any drug allergies and changes in the method of administration

 

• Denosumab: minimising the risk of osteonecrosis of the jaw; monitoring for hypocalcaemia—updated recommendations  

Denosumab is associated with a risk of osteonecrosis of the jaw (ONJ) and with a risk of hypocalcaemia. Before starting denosumab treatment, a dental examination and appropriate preventive dentistry are now recommended to reduce the risk of osteonecrosis of the jaw (ONJ).

 

• Nitrofurantoin now contraindicated in most patients with an estimated glomerular filtration rate (eGFR) of less than 45 ml/min  

Nitrofurantoin is now contraindicated in patients with an estimated glomerular filtration rate (eGFR) of less than 45 ml/min. However, a short course (3 to 7 days) may be used with caution in certain patients with an eGFR of 30 to 44 ml/min.

 

 

 

Yellow Card Scheme update

• New guidance on reporting suspected adverse drug reactions in children  

We are publishing new guidelines for reporting suspected adverse drug reactions (ADRs) in children and adolescents aged under 18 years via the Yellow Card Scheme.

 

 

 

Stop Press

• Domperidone: risk of cardiac side effects – no longer available without prescription 

Domperidone should no longer be sold to anyone without a prescription. It is associated with a small increased risk of serious cardiac side effects.