UK MHRA Drug Safety Update (Volume 7, Issue 6)

• Prasugrel (Efient): increased risk of bleeding—information on timing of loading dose

  New clinical trial information is available on the timing of the loading dose of prasugrel when used in patients with unstable angina or non-ST segment elevation myocardial infarction. In these patients, when coronary angiography is done within 48 hours after admission, the loading dose should only be given at the time of percutaneous coronary intervention.

 

• Ofatumumab: screen for hepatitis B virus before treatment

  All patients should be screened for hepatitis B virus infection before starting treatment with ofatumumab. Patients with active infection with this virus should not be treated with ofatumumab.

 

• Temozolomide: risk of hepatic injury, including fatal hepatic failure—updated warnings and monitoring guidance

  Hepatic injury, including hepatic failure with fatal outcome, has been reported in patients treated with temozolomide. Liver function should be tested before and during treatment with temozolomide.

 

• Capecitabine: risk of severe skin reactions—discontinue treatment

  Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported during treatment with capecitabine. Some cases were fatal.

 

Posted on the UK MHRA website on 23 January 2014