Pharmaceutical drug killing asthmatics – UK government investigates

The government is to investigate an asthma drug which has been linked with fatalities. However, experts stress that there is no evidence to suggest the drug is unsafe and have urged asthmatics to continue with their medication.

(BBC News) -- Salmeterol, also known as Serevent, is marketed by GlaxoSmithKline who launched a US trial into the drug after reports of deaths.

Early results showed a trend towards increased asthma deaths and serious problems among patients, particularly African-Americans and those not taking inhaled steroids.

Trial

But the trial was halted abruptly after GlaxoSmithKline said it could not recruit enough volunteers.

A spokesman for the Department of Health confirmed that they had received 1,826 suspected adverse drug reactions linked to Salmeterol in the UK since 1989.

Just because an adverse reaction is reported it does not necessarily mean that the drug was responsible

Spokesman for Department of Health

But said that this did not indicate that the drug was responsible for the problems.

"It is important to note that just because an adverse reaction is reported it does not necessarily mean that the drug was responsible.

"Many factors affect the number of adverse reaction that are reported - these include the usage of the drug, the length of time it has been marketed and any publicity surrounding the drug.

Unclear

"The Medicines Control Agency (MCA) is aware of the results and premature termination of a US study examining the safety of Salmeterol and the Committee on Safety of Medicines (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."

The MCA said the US drug findings were unclear, but said it could be due to the way it was used there.

This differs from the way Salmeterol is used in the UK, where it is normally used in addition to treatment with inhaled corticosteroids.

Professor Martyn Partridge, chief medical adviser of the National Asthma Campaign agreed: "Irrespective of the medication you are on, it seems that if you are a male African American with asthma, you are more likely to die from the condition.

"This may reflect socio-economic factors, access to healthcare, environment or as yet unknown genetic factors.

"The likeliest explanation for the results reported here is that the patients were taking the airway opener (Salmeterol) and not the essential corticosteroid.

"They reflect the way the medicine is used rather than the actual medicine itself."

Guidelines

A spokeswoman for GlaxoSmithKline said that in the UK guidelines for prescribing Salmeterol, clearly stated that it should only be prescribed if combined with an inhaled steroid.

She said that the US guidelines did not limit its use in this way.