Kids and Serevent (Take 3)
Looks like the FDA may use tougher language on the Serevent and Advair black box warnings.
At least, that’s what yesterday’s committee suggested to the FDA after considering salmeterol’s possible side effects in asthmatic children.
The current warning should address children specifically, says the independent committee, and it should warn that using the drug increases the risk of hospitalizations. GlaxoSmithKline, the manufacturer of Serevent and Advair, disagrees that the warning needs to be changed, and you can read the full statement here. (Click on the link for November 28th.) You can also find the current text of the Serevent black box warning below the cut on this post.
The FDA itself is planning a formal review of long-acting beta-agonist (LABA) use in children.
Steve (who knows this kind of stuff personally and professionally as a severe asthmatic and a former respiratory therapist) made a good point in the comments yesterday. Some asthma patients can’t tolerate any beta-agonists, not even the short-acting albuterol. It’s unclear to me, after reading the news reports, if the most recent research on salmeterol took this factor into account. Anyone else know? Steve?
The Asthma Girl stays under good control with Flovent, so she has never used an LABA. This issue, though, highlights two features of my perspective on parenting my asthmatic child:
1. Always be informed. More information, whether on this asthma topic or any other, is always a good thing.
2. With the doctor’s help, always watch AG closely for reactions to all medications, and be aware of what she can’t tolerate. She can’t, for example, take Singulair without gastrointestinal side effects, but it’s a miracle drug for many, many other people with asthma.
Current Serevent Black Box Warning
Long-acting beta2-adrenergic agonists, such as salmeterol, the active ingredient in SEREVENT DISKUS, may increase the risk of asthma-related death. Therefore, when treating patients with asthma, SERVENT DISKUS should only be used as an additional therapy for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies, including SEREVENT DISKUS. Data from a large placebo-controlled US study that compared the safety of salmeterol (SEREVENT Inhalation Aerosol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 patients treated for 28 weeks on salmeterol versus 3 deaths out of 13,179 patients on placebo) (see WARNINGS and CLINICAL TRIALS: Asthma: Salmeterol Multi-center Asthma Research Trial).
–from the Serevent Prescribing Information and Medication Guide pdf