CSM to scrutinise Serevent link to deaths from asthma
The Government is to investigate the asthma drug Serevent (salmeterol) following the termination of a trial that suggested it may be linked to an increased risk of life-threatening asthma episodes and deaths.
The GlaxoSmithKline trial into the safety of the long acting ?-2 agonist was carried out in the US. It intended to enrol 60,000 patients but was halted after just 26,000.
The US drugs regulatory body, the Food and Drug Administration, ordered GlaxoSmithKline to run the trial after receiving 'several' reports of asthma deaths associated with Serevent.
Early results showed a trend towards increased asthma deaths and serious asthma episodes among all patients, representing more than 4.3 million patient days of exposure. The risk appeared greatest in African-Americans and those not taking inhaled steroids.
GlaxoSmithKline said it stopped the trial because of difficulties enrolling patients.
A spokeswoman for the Department of Health said: 'The Medicines Control Agency is aware of the results and premature termination of a US study examining the safety of salmeterol and the CSM will be reviewing these data in the near future.
'There is no need for patients taking Serevent to be concerned or to stop taking their treatment.'
Since 1989, the Committee on Safety of Medicines has
received 1,826 yellow card
reports of suspected adverse reactions to salmeterol.
Some 120 had a fatal outcome 61 linked to adverse respiratory reactions, 56 to adverse cardiovascular reactions, two to cerebrovascular reactions, and one suspected
GlaxoSmithKline said UK prescribing information for Serevent clearly stated it should only be prescribed in combination with an inhaled steroid. US guidelines do not limit its use in this way.