Salmetrol can worsen asthma; even lead to death

Azrol, Salmeter, Serobid, ForAir include salmetrol-containing medicines sold in India

Asthma medicines contains salmetrol can aggravate asthma and even result in the death of patients using them, according to US FDA.

Salmetrol, which is marketed as Serevent by GlaxoSmithKline is one of the widely used medicines to treat asthma in many countries around the world.

In India, salmetrol formulations are being sold under different brand names including Azrol (Sun Pharma), Salmeter (Dr Reddy’s), Serobid (Cipla Ltd), ForAir (GSK) etc.

Salmetrol belongs to the Long-Acting Beta-Agonists (LABAs), a class of medications used for the treatment of asthma and chronic obstructive pulmonary disease (COPD).

The new recommendations in their drug label intended to promote their safe use in the treatment of asthma. The new recommendations do not apply to the use of LABAs for the treatment of COPD.

In February 2010, the agency announced it was requiring manufacturers to revise their drug labels because of an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations, in pediatric and adult patients, as well as death in some patients using LABAs for the treatment of asthma (see February 2010 LABA Drug Safety Communication1).

In India, salmetrol- the most commonly used LABA drug)- formulations are being sold under different brand names including Azrol (Sun Pharma), Salmeter (Dr Reddy’s), Serobid (Cipla Ltd), ForAir (GSK) etc.

Drugs including salmetrol do not relieve sudden-onset asthma symptoms. Patients should always have a rescue inhaler, such as an albuterol inhaler, to treat sudden onset asthma symptoms, US FDA alerts in its latest additional safety information for patients.

Salmetrol must never be taken alone for the treatment of asthma.

If patients need a long-term asthma control medication that is not available as a combination product, they should work with healthcare professional to ensure that each medication is taken correctly.

And healthcare professionals are advised not to start salmetrol class of drugs in patients with acutely deteriorating asthma.

Doctors should discuss with patients and families the warning signs of worsening asthma and advise them to seek immediate medical attention should their condition deteriorate.

In pediatric and adolescent patients who need the addition of a salmetrol drug to an inhaled corticosteroid, prescribe a combination inhaled corticosteroid – LABA product.
Using a combination product will help ensure adherence with both of these medications, US FDA said.

In February 2010, US FDA announced it was requiring manufacturers to revise their drug labels because of an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations, in pediatric and adult patients, as well as death in some patients using LABAs for the treatment of asthma.

Salmetrol manufacturers will be required to include this warning in the product labels of these drugs, along with taking other steps to reduce the overall use of these medications.

These new requirements are based on US FDA analyses of clinical trials showing that use of these long-acting medicines is associated with an increased risk of severe worsening of asthma symptoms, leading to hospitalization in both children and adults and death in some patients with asthma.

These medications improve a patient’s ability to breathe freely and reduce the symptoms of asthma by relaxing muscles in the lung’s airways.

The manufacturers of LABAs to conduct additional studies to further evaluate the safety of LABAs when used in combination with inhaled corticosteroids.

In addition to these actions, FDA will work with public and private partners under the agency’s ongoing Safe Use Initiative to study LABA prescribing practices.

Advair is marketed by GlaxoSmithKline under various trade names including Advair (US, CA), Seretide (EU, Australia), Viani (Germany), Adoair (Japan).