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UK drug agency announces review of use of alteplase after stroke

BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g5355 (Published 01 September 2014) Cite this as: BMJ 2014;349:g5355
  1. Deborah Cohen,
  2. Helen Macdonald
  1. 1The BMJ

The UK Medicines and Healthcare Products Regulatory Agency has announced it is to review the “balance of benefits and risks” of the use of alteplase in the treatment of acute ischaemic stroke.

In a letter published in the Lancet on 23 August,1 Ian Hudson, chief executive of the MHRA, announced that the agency was setting up a panel of experts to review “any new information or concerns about the data that underpin the present marketing authorisation” for the drug, but he added that the data supporting alteplase use had been “extensively discussed” and that the “benefit-risk balance is favourable.”

The MHRA’s announcement was prompted by concerns raised by Roger Shinton, a former consultant physician at Birmingham’s Heartlands Hospital in another letter in the same issue of the Lancet.2

Alteplase, a thrombolytic drug, is licensed in Europe for the management of acute ischaemic stroke within four and a half hours of onset of symptoms and in the United States for use within three hours. In his letter Shinton highlighted several concerns with the initial trial used to obtain marketing approval for alteplase3 and a subsequent trial that was key to extending its window of use in Europe from three to four and a half hours.4

In the first trial, called the National Institute of Neurological Disorders and Stroke (NINDS) trial, participants were randomised to …

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