Alteplase is safe to use within existing treatment guidelines, says independent review

The thrombolytic drug alteplase is safe and effective for licensed use up to 4.5 hours after the onset of symptoms of acute ischaemic stroke in patients for whom it is licensed, an independent expert group set up by the UK Medicines and Healthcare Products Regulatory Agency has concluded.1

The group emphasised that the chances of a more favourable outcome for patients were greater the earlier the treatment was given.

However, some other doctors are concerned that the review has not seen all the evidence and that the safety of alteplase remains uncertain.

The MHRA’s review was announced in August 2014,2 after concerns about the drug were raised by Roger Shinton, a former consultant physician at Birmingham’s Heartlands Hospital, in a letter to the Lancet.3 He raised several concerns about the initial trial used to obtain marketing approval for alteplase4 and a later trial that was key to extending its window of use in Europe from three to four and a half hours after onset of symptoms of stroke.5 Other clinicians have also raised questions about its use beyond three hours.6

The expert group reviewed all available evidence on alteplase, which included extensive published literature, data from the holder of the marketing authorisation, submissions from individual clinicians, information from professional bodies, …