Researchers say they will send unpublished alteplase data to UK drug regulator on requestBMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h119 (Published 09 January 2015) Cite this as: BMJ 2015;350:h119
- Deborah Cohen,
- Helen Macdonald
- 1The BMJ
Previously unpublished data that could potentially resolve concerns over the safety and efficacy of the acute ischaemic stroke drug alteplase will be made available to the UK drug regulator on request, an email seen by The BMJ has indicated.
Alteplase is the only thrombolytic drug with a licence for the management of acute ischaemic stroke. In some countries in Europe, including the United Kingdom, it is marketed for use within four and a half hours of onset of symptoms, and in the United States it is marketed for use within three hours.
However, the use of alteplase has been shrouded in controversy almost since the drug was approved (1996 in the US and 2002 in parts of Europe), with some doctors and academics questioning its efficacy and safety and the methodology of some of the trials.
In August 2014 the UK Medicines and Healthcare Products Regulatory Agency (MHRA) convened a group of experts to review “any new information or concerns about the data that underpin the present marketing authorisation” of alteplase,1 after a letter in the Lancet …