Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website with over 30,000 members from 169 Countries.
MHRA alert: Denosumab
The UK MHRA has sent out two drug safety updates regarding denosumab use:
- risk of new primary malignancy when used for the prevention of skeletal-related events in adults with advanced malignancies involving bone; in a pooled analysis of four studies, the incidence of a new primary cancer was twice as common with denosumab 120mg (1.1%) vs. zoledronic acid 4mg (0.6%) at 1 year
- discontinuation hypercalcaemia in patients with giant cell tumour of bone; clinically significant hypercalcaemia has occurred in patients with giant cell tumour of bone <9 months of stopping denosumab (estimated frequency of <1%). Patients should be regularly monitored for signs and symptoms of hypercalcaemia (± plasma calcium) and their need for calcium and vitamin D supplementation re-evaluated.
Note. This information is included in the new on-line PCF denosumab monograph, which will be available shortly.
FDA safety communication: OTC benzocaine products
The US Food and Drug Administration (FDA) has warned that over-the-counter (OTC) oral drug products containing benzocaine should not be used to treat children <2 years because of the rare but potentially life-threatening risk of methemoglobinemia versus the little/lack of benefit for teething/oral pain. For more information, click here.
Palliative care included in updated standards for HIV
The British HIV association has recently updated its standards of care for people living with HIV to include palliative care. For more information, click here.
Resources to support safer modification of food and drink
A resource patient safety alert has been issued to eliminate use of the imprecise term ‘soft diet’ and assist with the safe transition to the International Dysphagia Diet Standardisation Initiative (IDDSI) framework, which introduces standard terminology to describe texture modification for food and drink. For more information, click here.
Diamorphine 5mg and 10mg injection shortage
Accord Pharmaceuticals has manufacturing difficulties with 5mg and 10mg diamorphine injection. The other UK supplier (Wockhardt) only has a small stock and is not expected to be able to keep up with the extra demand. Diamorphine 30mg, 100mg and 500mg are not affected. NHS organizations are strongly requested to order as normal and not to stockpile, as this will exacerbate the situation.
Danazol now contra-indicated with simvastatin
The UK SPC for danazol capsules now contra-indicates concurrent use with simvastatin because of the risk of myopathy and rhabdomyolysis from increased simvastatin levels. Although not specifically contra-indicated, the risk if also increased with other statins metabolized by cytochrome P450 3A4 enzyme, e.g. atorvastatin, lovastatin. For more information, click here.
FDA approves cannabidiol oral solution
The US FDA has approved a cannabidiol (CBD) oral solution (Epidiolex) for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome. This is the first approved product that contains purified CBD from the Cannabis sativa plant without the psychoactive tetrahydrocannabinol (THC) component. A marketing authorization application has been submitted to the European Medicines Agency for this product and indication, however it has not yet been authorized in the EU. For more information, click here.
Terms and conditions (updated May 2018)
PCF updated monographs summary (May and June 2018)
The on-line Palliative Care Formulary is being continually updated. The following monographs have been updated during May and June 2018 and supersede those in the print publication of the 6th edition of the Palliative Care Formulary (PCF6). They can be accessed from the formulary section of the website.
Chapter 04: Antihistaminic antimuscarinic anti-emetics (Full update May 2018, minor change June 2018), QCG: Nausea and vomiting (minor change), QCG: Inoperable bowel obstruction (minor change), QCG: Vertigo (minor change)
Chapter 05: Morphine (minor change)
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Prepared by Sarah Charlesworth and Andrew Wilcock