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New asthma drug label information enforced

The US Food and Drug Administration has ordered updated information on the labels of certain asthma medications following safety concerns

The US Food and Drug Administration (FDA) has ordered several pharma companies to update information on the labels of certain asthma medications.

The revised labelling will apply to Long-Acting Beta-Agonists (LABAs), a class of medications used in asthma and chronic obstructive pulmonary disease (COPD), after serious safety concerns were reported with the drug in the treatment of asthma.

These included an increased risk of severe exacerbation of asthma symptoms, leading to hospitalisations, and even some instances of death in asthma patients using LABAs.

LABAs are used to improve asthma symptoms by increasing airflow through the lungs.

The affected drugs are GlaxoSmithKline's (GSK) Serevent (salmeterol) and Advair (salmeterol fluticasone), Merck/Schering-Plough's Foradil (formoterol) and AstraZeneca's (AZ) Symbicort (formoterol budesonide).

Sepracor's Brovana (arformoterol) and Dey's Perforomist (formoterol fumarate) are also LABAs, but are recommended only for COPD. The new labelling information only applies to treatments recommended for asthma.

New guidelines on the updated labels include advising against using the treatment alone without a long-term asthma control medication; recommending that LABAs should not be used in patients whose asthma is adequately controlled by inhaled corticosteroids; and recommending that LABAs should only be used as an additional therapy in patients who are taking long-term asthma control medication, but for whom the disease is not under control.

It is also recommended that once a patient's disease is under control, they should be assessed at regular intervals with the commencement of step down therapy, such as the discontinuing of LABA.

Younger patients who require a LABA should use a combination product containing both an inhaled corticosteroid and a LABA to ensure adherence with both medications.

The FDA said when LABAs are used in accordance with the new recommendations, the "benefits of LABAs in improving asthma symptoms outweigh their risks of increasing severe asthma exacerbations and deaths from asthma".

GSK, whose Serevent and Advair are affected, has said it will "work quickly to implement changes described in the FDA's correspondence and communicate these changes to healthcare providers".

Dr Cathy Bonuccelli, vice president, Clinical Respiratory & Inflammation, AZ, said: "AstraZeneca is confident in the positive benefit-risk profile of Symbicort in asthma. Combination therapies, such as Symbicort, continue to play a critical role in helping appropriate patients control asthma symptoms. Regular assessments of patients' asthma control by their physicians is important for ensuring that they are on the appropriate therapy based on their individual treatment needs."

Along with the enforced labelling, the FDA offered additional advice for patients and healthcare professionals.

Patients using LABAs are advised to always have a rescue inhaler; that LABAs must never be taken alone for the treatment of asthma; and they are to work with their healthcare professional on the correct medication process if a combination long-term asthma control medication is unavailable.

Healthcare professionals should not begin LABA treatment in patients with acutely deteriorating asthma; they should encourage patients, families, and caregivers to read the Medication Guide that accompanies LABA prescriptions; and they should prescribe a combination inhaled corticosteroid/LABA product for younger patients who require a LABA.

3rd June 2010

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