Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.
Safety updates
Lenalidomide investigation of risk of second primary malignancies in myeloma
Data from three large controlled clinical trials investigating use of lenalidomide in patients with newly diagnosed multiple myeloma have recently shown a signal of an apparent excess of second primary malignancies. On the basis of this observation, a review of the balance of benefits and risks of lenalidomide in its authorised indication is being undertaken in the EU. The UK Medicines and Healthcare products Regulatory Agency (MHRA) have stated that the use of lenalidomide in newly diagnosed multiple myeloma or other unlicensed indications (unless part of a current trial) is not recommended and that healthcare professionals should be vigilant for the occurrence of second primary malignancies when used in its authorised indication, and should report such events promptly. For more information click here.
Thalidomide increases risk of arterial thrombosis
The MHRA have highlighted the following in their July Drug Safety Update:
Patients treated with thalidomide have an increased risk of arterial thromboembolism, including myocardial infarction and cerebrovascular events, in addition to the established risk of venous thromboembolism. Healthcare professionals should consider venous and arterial thrombotic risk and administer antithrombotic prophylaxis for at least the first five months in patients commencing thalidomide. For more information click here.
Bisphosphonates and atypical femoral fractures
The European Medicines Agency (EMEA) Committee for Medicinal Products for Human use (CHMP) has concluded that rare atypical femoral fractures are a class effect of bisphosphonates.
Atypical femoral fractures have been reported rarely and mainly in patients receiving long-term treatment for osteoporosis. The overall benefits of bisphosphonates in their licensed indications continue to outweigh their risks. Patients on bisphosphonates should be advised to report any hip, thigh or groin pain.
The EMEA review and MHRA guidance to healthcare professionals contain further information.
Reports on addiction to prescribed and over-the-counter medicines published
The MHRA July Drug Safety Update has highlighted the publication of two reports commissioned by the Department of Health on addiction to prescribed and over-the-counter medicine. They feature benzodiazepines and codeine containing medicines. For more information click here.
Risk of accidental overdose with IV paracetamol
Letters have been sent out by the MHRA to healthcare professionals highlighting the risk of accidental overdose with confusion over the strength of paracetamol 10mg/mL intravenous infusion, particularly in children. There have been several fatalities worldwide where 10 times the dose has been given in error. Special care and attention should be given to prescribing and administering the dose. In addition the 100mL infusion bags (containing 1g paracetamol) should only be used in patients weighing >33kg. For more information click here.
Prepared by Sarah Charlesworth and Andrew Wilcock