NHS Greater Glasgow & Clyde Area Drug and Therapeutics Committee
Greater Glasgow and Clyde Medicines
Medicines Update Oncology

Drug Safety Updates: bisphosphonates, trametinib and idelalisib

The Medicines Healthcare and Regulatory Authority (MHRA) have published new safety information relating to the following:

Bisphosphonates: Osteonecrosis of the external auditory canal. There have been very rare reports of osteonecrosis of the external auditory canal, mainly in association with long-term bisphosphonate therapy.  To see MHRA advice for healthcare professionals including recommended monitoring click here. The West of Scotland Cancer Network protocol for Prevention of Skeletal Related Events in Cancer will be updated to reflect this advice.

Trametinib: Risk of gastrointestinal perforation and colitis. Use trametinib, either as monotherapy or in combination with dabrafenib, with caution in patients with risk factors for gastrointestinal perforation. Suspected adverse reactions to trametinib should be reported on a Yellow card. To see MHRA advice for healthcare professionals including recommended monitoring click here. Please note: there is currently no West of Scotland Cancer Network protocol for this drug.

 

The European Medicines Agency (EMA) have published a press release relating to the following:

Idelalisib: Serious concerns over adverse events in ongoing clinical trials. Idelalisib, which is used for the treatment of follicular lymphoma and chronic lymphocytic leukaemia is being reviewed because of an increased rate of serious adverse events including death, mostly due to infections. To see the full EMA review click here.  West of Scotland Cancer Network protocols for idelalisib will be revised to reflect this risk.