FDA Says LABA Asthma Drugs Not for Solo Use

[Guest guest]

 The below FDA WARNING, is for those of us, like myself, who suffer from BOTH, a

Toxic Mold Reaction, AND an Allergic/Asthmatic Mold Reaction.

Joe

 

By  Gever, Senior Editor, MedPage Today

Published: February 18, 2010

 

Long-acting beta agonist (LABA) agents should never be used alone in children or

adults with asthma, the FDA said today in announcing label changes and other

initiatives intended to promote safe use of these popular drugs.

Package inserts for the two single-agent LABAs approved for asthma, salmeterol

(Serevent) and formoterol (Foradil), will be changed to require that the drugs

always be used in combination with an asthma controller medication such as an

inhaled corticosteroid, according to the FDA.

Other new items to be required on the products' labels include:

LABAs should only be used long-term in patients with asthma not adequately

controlled with inhaled steroids or other controller medications.

The agents should be used for the shortest time possible to achieve symptom

control. Once patients are no longer experiencing symptoms, LABAs should be

discontinued if possible with patients maintained on controller medications

alone.

Children and adolescents needing a LABA should use a combination product that

also contains an inhaled steroid to ensure compliance with both medications.

The FDA is not requiring any label changes for another LABA drug, arformoterol

(Brovana), or a version of formoterol sold as Perforomist, which are approved

only for chronic obstructive pulmonary disease (COPD).

The label changes also won't apply to LABAs used for intermittent

exercise-induced bronchospasm.

Thus far, the risks associated with LABAs have been seen only in asthma

patients.

Those risks include severe exacerbations of asthma symptoms, leading to

hospitalizations for adults as well as children. Some of these exacerbations

have been fatal.

The FDA cited data from a placebo-controlled trial called SMART in which

salmeterol was associated with excess deaths at an overall rate of 8 per 10,000

patients (95% CI 3 to 13). The risk was especially pronounced in African

Americans, in whom the excess death rate was 27 per 10,000 (95% CI 8 to 46).

A meta-analysis of some 60,000 patients in multiple trials of salmeterol and

formoterol found that the drugs were associated with a composite of

hospitalizations, intubations, and deaths at an excess rate of 28 per 10,000

patients (95% CI 11 to 45).

These events were markedly more frequent in adolescents (58 per 10,000) and

children (148 per 10,000).

The FDA emphasized that it still believes the drugs' benefits outweigh the

risks, which is why it is not simply pulling them from the market.

" We think the greater public health benefit is to overall reduce the use of

LABAs, but keep them available for patients who need an additional therapy, "

said , MD, director of the FDA's Office of New Drugs, in a telephone

briefing for reporters.

said most patients using LABAs already are doing so in combination with

inhaled steroids, but concerns about the risks make it prudent to further

discourage their use.

The officials pointed out that it is not yet certain that using LABAs in

combination with inhaled steroids reduces these events, but clinical trials with

combination products to date have not suggested this type of safety problem.

In addition to the label changes, the FDA is also requiring that manufacturers

develop risk evaluation and mitigation strategies. These must include new

medication guides for patients and an education plan for healthcare

professionals about the appropriate use of LABAs, the FDA said.

The FDA is also requiring that LABA manufacturers begin new studies to evaluate

the drugs' safety when combined with inhaled steroids. The agency will convene a

public meeting next month to take input on how these studies should be designed.

Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and

Research, said during the press call that the agency would monitor prescribing

patterns to determine whether LABAs continue to be prescribed as solo

treatments.

" If we find this is still happening, we can work with our partners [in the Safe

Use Initiative] to directly provide information to those practitioners and

patients to make sure they have the knowledge needed to use these drugs safely, "

she said.

The Safe Use Initiative was started by FDA last year to collaborate with

physicians, hospitals, pharmacies, insurers, and other groups to reduce

preventable harms associated with drugs, such as medication errors and abuse as

well as adverse biological effects in normal use.

Woodcock emphasized that the FDA would not target individual physicians itself,

but would use these partnerships to discourage solo use of LABAs if the data

indicate it is continuing.

 

Link to original article, below:

http://www.medpagetoday.com/InfectiousDisease/PublicHealth/18552#rate