Resources to support safer modification of food and drink

28th June 2018

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.

Note. Information about swallowing capsules and tablets is included in the frequently asked questions section of the IDDSI website.

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MHRA alert: Denosumab

28th June 2018

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.

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MHRA valproate prescribing resources available

27th June 2018

Resources and further information are now available from the MHRA and Royal Pharmaceutical Society (RPS) to support the prescribing of valproate in women and girls of child-bearing potential under the conditions of the pregnancy prevention programme (see our news item MHRA: Valproate updated contra-indications).

MHRA resources

RPS resources

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FDA approves cannabidiol oral solution

26th June 2018

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.

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FDA safety communication: OTC benzocaine products

24th June 2018

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.

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Danazol now contra-indicated with simvastatin

6th June 2018

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.

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