Neuro risk prompts metoclopramide PI change
Product Information for the antiemetic and gastroprokinetic drug metoclopramide has been updated to include a new contraindication to reduce the risk of neurological adverse events.
There are also changes to the drug’s dosing and duration of use, as revealed by the TGA in its latest Medicines Safety Update.
The TGA said it has received 2190 adverse event case reports associated with metoclopramide over a 43 year period. Among these were 16 cases of tardive dyskinesia and 86 cases of other extrapyramidal disorders.
There were also nine reports of cardiac arrest and a further 63 reports of cardiac arrhythmias.
PI changes include a maximum dosage for adults of 30 mg daily, with a maximum treatment duration of five days in all age groups. It is only to be used as a second-line therapy in young adults and children.
Adhere to Vit D guidelines: expert
Vitamin D supplementation should only be started in patients with low circulating levels of vitamin D are low and when patients are at increased risk of falls or fractures, an experts advises.
In the latest edition of Australian Prescriber, University of WA endocrinologist, Dr Paul Glendinning states that vitamin D testing is very commonly requested, but new Australian guidelines state for whom supplementation should be used.
“Vitamin D testing has become more common, but testing is recommended for those at risk of vitamin D deficiency, not for healthy babies, children and adults,” he said.
“The guidelines - broadly consistent with current evidence - propose testing in individuals at increased risk of vitamin D deficiency and provide clinical indications for vitamin D measurement. Vitamin D deficiency is associated with osteoporosis or osteomalacia, and with rickets in children.”
Evidence from an Australian randomised study in 2200 women at high risk of hip fracture has questioned the use of annual high-dose cholecalciferol therapy, Dr Glendinning said.
He believes that in this population “daily, weekly or even monthly vitamin D replacement therapy can probably be safely used, but annual high-dose replacement should be avoided”.
He said a 25-hydroxyvitamin D threshold of at least 50 nanomol/L at the end of winter is a suitable treatment target. Measurement can be repeated after three months of repletion, and thereafter less frequently unless new risk factors for vitamin D deficiency arise.