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Safety Updates

McKinley T34 extension sets: UK Medicines and Healthcare products Regulatory Agency (MHRA) issue recall

All T34 syringe pump extension sets manufactured by CME (McKinley Medical UK) before 1 January 2011 have been recalled due to the potential for leakage at the female luer syringe connector. Product codes affected are: 100-172S, 100-170S, 100-172SLL, 100-172SB, 100-172SC. Returns and replacement stock can be obtained by contacting Paul Fletcher (McKinley Medical UK, 01253 894646, email: The manufacturer states that other syringe sets can be used in the interim (ensuring local guidelines and practice are adhered to). For more information click here.

European Medicines Agency (EMEA) complete review of potential interaction between alcohol and opioid modified-release mechanisms

This review was undertaken following reports of the risk of alcohol dissolving the modified-release coating leading to a more rapid release of drug than intended. The conclusions are that for the majority of modified-release products the risk is minor but that the SPC and PIL across the whole class should be updated with consistent warnings that the concomitant use of alcohol with opioids may enhance the pharmacodynamic effect and should be avoided. However, for modified-release drugs which use a ‘polymethacrylate-triethylcitrate controlled release system’, the EMEA concluded that the marketing authorizations should be suspended until formulations which are more stable in alcohol are produced. The affected product appears to be Ethirfin (morphine sulphate, prolonged-release capsules, 20, 60, 120 and 200mg) previously available in Denmark. For more information click here.

Lenalidomide: UK Medicines and Healthcare products Regulatory Agency (MHRA) safety warning

Lenalidomide (Revlimid, Celgene) is authorised in combination with dexamethasone for multiple myeloma in patients who have received at least one previous treatment. However, evidence from clinical trials and case reports suggest that lenalidomide further increases the already elevated risk of venous and arterial thrombo-embolism in these patients, including myocardial infarction and cerebrovascular accident. The SPC has been amended accordingly. For more information click here.

US Food and Drug Administration (FDA) limits the amount of acetaminophen (paracetamol) to 325mg per dosage unit

The US FDA has asked manufacturers to reformulate prescription products containing acetaminophen (paracetamol) so that a single dosage unit contains a maximum of 325mg acetaminophen. This includes combination products of acetaminophen and opioids. Dosage recommendations will not change and the maximum dose remains 4g/day. For more information click here.

US Food and Drug Admnistration (FDA) announces Risk Evaluation and Mitigation Strategy (REMS) for modified-release opioids

The US FDA has published its REMS for all modified-release opioid drugs which aims to reduce their inappropriate prescribing, misuse, and abuse. Manufacturers are required to develop an educational program for prescribers and patients. For more information click here.

Prepared by Sarah Charlesworth and Andrew Wilcock

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