Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.
Hot topics
EMA review of cardiovascular safety of NSAIDs
The European Medicines Agency (EMA) has finalised a review of recently published information on the cardiovascular safety of non-steroidal anti-inflammatory drugs (NSAIDs). The review confirms the findings from previous reviews which concluded that the overall benefit-risk balance of NSAIDs remained positive, but that a small increased cardiovascular risk could not be excluded.
Most of the data related to diclofenac, ibuprofen and naproxen. The latest evidence continues to find a small increase in the risk of cardiovascular undesirable effects for diclofenac compared with other non-selective NSAIDs, similar to the risks of COX-2 inhibitors, particularly with long-term use of high doses and in patients already at high risk. Warnings are already included in the SPC. However, the EMA will now assess all available data on diclofenac (both published and unpublished) to consider the need for updated treatment advice. In relation to naproxen and ibuprofen, the current treatment advice adequately reflects the knowledge regarding the safety and efficacy of these medicines. For more information click here.
Denosumab; fatal cases of severe symptomatic hypocalcaemia
The UK Medicines and Healthcare products Regulatory Agency (MHRA) have highlighted cases of severe symptomatic hypocalcaemia that have occurred in patients receiving denosumab 120mg (Xgeva®; authorized for use in prevention of skeletal related events in adults with bone metastases from solid tumours) or 60mg (Prolia®; authorized for use in osteoporosis).
Hypocalcaemia is a known risk with denosumab use, especially in patients with severe renal impairment (creatinine clearance <30 mL/min) or receiving dialysis. Severe symptomatic hypocalcaemia, including three fatal cases, has been reported in patients receiving denosumab 120mg. Although hypocalcaemia with denosumab most commonly occurs within the first 6 months of dosing, it can occur at any time during treatment.
Pre-existing hypocalcaemia must be corrected prior to initiating denosumab, and supplementation of calcium and vitamin D is required in all patients receiving the 120mg dose unless hypercalcaemia is present. Periodic monitoring of calcium levels (at the discretion of the prescriber) is recommended after use of denosumab in patients predisposed to hypocalcaemia, including those with severe renal impairment. For more information, click here.
LCP independent review
Following a round table discussion, Norman Lamb (Minister for Care and Support) is to appoint an independent chair to understand what lies behind the reports of poor quality care associated with the implementation of the Liverpool Care Pathway (LCP) in the UK media and oversee and validate the review work initiated by the National End of Life Care Programme, the Association for Palliative Medicine and Dying Matters. The results of the independent review will be reported next year. For more information click here.
MHRA Medicines Device Alert for Inadine dressings
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Medicines Device Alert for Inadine® PVP-I non adherent dressing (9.5cm x 9.5cm) manufactured by Systagenix Wound Management (Product code: P0149; Lot numbers: 1227/1228/1229). There is a possible risk of infection due to compromised sterility, and the affected batches should not be used. For further information click here.
Prepared by Sarah Charlesworth and Andrew Wilcock