FDA Wants More Safety Data On Asthma Meds
2 CommentsBy Ed Silverman // March 5th, 2008 // 1:13 pm
The FDA wants more info from the drugmakers about their long-acting beta agonists in order “to further evaluate the safety” of these asthma meds.
You may recall the agency asked the drugmakers to provide info from controlled clinical trials. The drugs include Glaxo’s Advair and Serevent; Novartis’ Foradil; AstraZeneca’s Symbicort; Mylan’s Perforomist, and Sepracor’s Brovana. The drugmakers say it will take several months to submit the info, according to a notice on the FDA web site. Meanwhile, the agency plans to hold an advisory committee meeting in the fall or winter to review the risks and benefits in adults and children in the fall or winter 2008.
Last November, an FDA panel recommended more warnings for kids for Advair and Serevent, which both contain the same active ingredient. The advisory committee also urged the agency to move quickly with another safety review of the drugs - including Foradil, a Novartis med that’s sold in the US by Schering-Plough - after one panel member questioned safe use in children.
The FDA had looked at adverse-safety events associated with Serevent and Advair from March 9, 2006, through April 9, 2007, as part of a routine safety review of drugs approved for use in children. The review found nine adverse-event reports in children and five deaths during its 13-month review period of Serevent.
The review of pediatric deaths possibly associated with Serevent from 1994 through 2007 showed 23 deaths, the FDA said, with 14 of the cases being reported as being caused by asthma exacerbation or a worsening of the condition. The agency noted that some patients will experience asthma exacerbations even when receiving appropriate therapy. A review of deaths possibly linked to Advair showed 15 pediatric deaths from 1999 through 2007. Advair, by the way, is Glaxo’s biggest-selling drug with 2007 worldwide sales of $6.9 billion.
New Asthma Patient
So many different Asthma meds.
Is it really necessary? Is this overkill for this category?
ol cranky
New patient:
The concern is over long acting beta agonists (some of these drugs are stand alone and some are combination meds with inhaled steroids). Beta agonists (bronchodilators) have long been watched due to concerns with tachyphylaxis which could lead a patient having an asthma exacerbation. This has been a well documented problem with salmeterol (the active ingredient in serevent and half of advair). The problem with the advair data (from the SMART study) as well as pot marketing surveillance is the inability to really separate out exacerbations due to tachyphylaxis from that due to the fact that GPs, who treat most asthma patients, do not follow the ATS algorithm for use of long acting beta agonists - in other words, the doc are not treating the patients’ asthma properly and, in way too many cases, are not prescribing the use of drugs containing a long acing beta agonist properly.
Formoterol (the active ingredient in foradil, oxis and 1/2 of symbicort) has the same black box warning as the salmeterol products, based on the assumption of class effect, but tachyphlaxis isn’t really a major problem for formoterol. The biggest problem with Foradil (novartis’ product) is the crappy delivery device and capsules - of course, the device is soooooooooooo bad, docs really don’t like to prescribe it (and patients don’t like to use it).