February 18th, 2010
07:49 PM ET
By Saundra Young
If you are an asthmatic who uses long-acting beta agonists–or LABAs– to treat your asthma symptoms, your medication may be doing more harm than good.
The Food and Drug Administration announced new safety warnings Thursday saying the medications should never be used alone by children or adults. The agency says it will require manufacturers to add additional warnings to the product labels, and ask doctors and patients to scale back overall use of the drugs.
"Patients with asthma should try to get on a single-agent steroid inhaler," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "And not try to get on combination medications with LABAs unless they really need them"
According to the FDA, LABAs put asthma patients at increased risk of severe, worsening symptoms; they lead to increased hospitalizations and even death. The LABAs in question contain the single drug Serevent or Foradil and can be in the combination medications Advair and Symbicort, which also contain inhaled corticosteroids. Corticosteroids supress inflammation and help reduce symptoms in inflammatory ailments such as asthma and arthritis. Advair contains Serevent, whose active ingredient is Salmeterol. Symbicort has Foradil; its active ingredient is Formoterol.
"Although these medications play an important role in helping some patients control asthma symptoms, our review of the available clinical trials determined that their use should be limited, whenever possible, due to an increased risk of asthma exacerbations, hospitalizations and death." said Badrul Chowdhury, director of the Division of Pulmonary and Allergy Products at the FDA's Center for Drug Evaluation and Research.
Children are of particular concern, said Dr. Dianne Murphy, director of the FDA's Office of Pediatric Therapeutics. "Parents need to know that their child with asthma should not be on a LABA alone."
The new labels will warn that:
*Long-term use should be only in patients whose asthma can't be controlled by controller medications
*LABAs should be used only for the shortest amount of time possible, and discontinued once asthma has been controlled. Patients should then be maintained on an asthma controller medication.
*Pediatric and adolescent patients who need a LABA in addition to inhaled corticosteroids should use a combination product that contains both a LABA and an inhaled corticosteroid
Novartis, maker of Foradil, released a statement saying, "Novartis and Merck will work closely with the FDA to assess the guidance provided in the Communication and determine appropriate next steps. We are committed to helping ensure that healthcare providers and patients have the most accurate and complete information regarding the safe and appropriate use of FORADIL. We will continue communicating with patients, caregivers and healthcare providers about FORADIL in ways that will help inform their decisions about appropriate treatment choices."
GlaxoSmithKline (GSK), which makes both Serevent and Advair, says it has 30 days to agree with the proposed changes - or say why they aren't necessary.
"We will work with FDA to ensure that the final label for these products protects the interest of patients who suffer with this chronic and serious disease," said Dr. Katharine Knobil, vice president for Respiratory Clinical Research at GSK. "It is important that doctors have flexibility to make the proper clinical decisions to help patients gain and maintain optimal control of their asthma."
According to the FDA, in a 2008 trial of more than 13,000 patients who took Salmeterol, there were 13 deaths. But GSK says in 10 years of clinical studies, there were no asthma-releated deaths in the nearly 18,000 patients who took Advair.
Drug makers will now have to do additional safety studies that look at LABAs when used with inhaled corticosteroids. And, the agency says it will continue to scrutinize prescribing patterns to make sure the new safety controls are being followed. LABAs are also approved to treat people with chronic obstructive pulmonary disease or COPD. However, the new recommendations apply only to treating asthma patients.
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