NPC Archive Item: August Drug Safety Update from MHRA/CHM

NOTE – This is an archive post from the NPC and has not been updated since first publication. Therefore, some hyperlinks may no longer be working.
merec_stop_press NPC Logo

NHS Evidence accreditation logo The Drug Safety Update is an NHS Evidence accredited provider

8th August 2008

The MHRA and CHM have published the August edition of Drug Safety Update. In this issue there is drug safety advice for antiepileptics and recombinant human erythropoietins; a hot topic article on thalidomide and lenalidomide for multiple myeloma; and stop press articles on moxifloxacin, caffeine for apnoea of prematurity, Accusol 35 solutions, intrathecal drug pumps and metronidazole for Clostridium-difficile-associated diarrhoea.

Drug Safety Update is an essential read for everyone whose professional practice involves medicines. It replaces Current Problems in Pharmacovigilance, and is published every month in electronic format only.

Antiepileptics: risk of suicidal thoughts and behaviour
A Europe-wide review has concluded that antiepileptic treatment is associated with a small increased risk of suicidal thoughts and behaviour. Evidence suggests that the increased risk is seen with all antiepileptic drugs and can occur as early as one week after starting treatment. Patients and caregivers should be alert to signs of these adverse effects throughout treatment, and patients should be referred for appropriate treatment if necessary.

Recombinant human erythropoietins: new recommendations for treatment of anaemia in cancer
As we reported in a previous blog, evidence suggests that recombinant human erythropoietins may be associated with an increased risk of tumour progression, and overall shorter survival times, when used in cancer patients. The decision to administer these drugs should be based on an informed risk-benefit assessment, taking into account tumour type and stage, degree of anaemia, life-expectancy, the environment in which the patient is being treated, and the patient’s preference. Blood transfusion should be the preferred option for treating anaemia in cancer patients who have a good prognosis.

Lenalidomide▼ and thalidomide▼ for multiple myeloma
As with thalidomide, lenalidomide is a potential human teratogen so the Pregnancy Prevention Programme is vital to minimise the risk in women of childbearing potential. Similarly, if their partner is pregnant or capable of becoming pregnant and is not using effective contraception, men must use condoms during lenalidomide or thalidomide treatment and for one week after dose interruption or cessation. Some serious side effects which are associated with thalidomide and lenalidomide are also highlighted.

Stop Press articles

  • Due to evidence of an increased risk of life-threatening liver reactions and other serious risks, the use of moxifloxacin has been restricted. It should only be used for treatment of acute bacterial sinusitis, acute exacerbation of chronic bronchitis, or community acquired pneumonia when other medicines cannot be prescribed, or have failed to be effective.
  • Some batches of Accusol 35 solutions have formed visible white precipitate during haemofiltration in continuous renal replacement therapy.
  • Caffeine 5 mg/ml solution for injection is now available as a licensed medicine for treatment of apnoea of prematurity. The dose regimen should be checked before use as this product may differ from unlicensed preparations previously used.
  • There is a risk of discontinuation of drug delivery to patients with the Codman Archimedes intrathecal drug pump.
  • Only oral metronidazole should be used for Clostridium-difficile-associated diarrhoea, except in exceptional circumstances and on the advice of a specialist.

Feedback: Please comment on this blog in the NPC discussion rooms, or using our feedback form