More knee-jerk reactionism from the FDA, this time over asthma drugs
Not that this is surprising given the amount of criticism they’ve received lately about unsafe drugs and inadequate testing.
The drugs in question are Serevent, Advair, and Foradil. Of the three, Advair is the most popular and is used by not only asthma patients, but those with emphysema, COPD, and a few other respiratory conditions. A panel of 14 asthma experts, led by Dr. David Graham, is convened today to discuss the safety of the drugs in question. This panel will decide whether or not to recommend the drug be pulled, re-labelled, or left as-is.
Advair and Serevent already carry warnings about a study that showed a small but significant increase in deaths among people who added the drugs to their usual asthma treatment: 13 deaths in 13,176 patients who took the drugs, versus 3 in 13,179 who took placebos. Foradil was not part of the study and does not carry such a warning.
These numbers may seem small, but in the medical world, they’re significant. Personally I do not believe that they are significant enough to warrant them being pulled from the market, but some people do. In the Real World, Serevent and especially Advair are super popular as a means of controlling asthma. Unlike typical albuterol inhalers, these medications are not meant to be used acutely because they will not stop an asthma attack already in progress. (In fact, they can exacerbate it.) Whether or not the figures above are gleaned from patients using the drug prophylactically (as it should be used) or when they are experiencing an attack is not known, but should be carefully looked at.
It should be stated that adverse reactions to medications happen all the time, and while somewhat more rare, adverse reactions that are the exact opposite of what is expected do occur. For instance, a patient taking an anti-histamine like Benadryl or Claritin for an allergic reaction (such as from a beesting) may experience a worsening of symptoms rather than relief. Asthma drugs are no different: people react differently to various medications which is why there is such a huge number of seemingly redundant medications on the market today. I think it is also important to not forget those patients who take these bronchodilators for other reasons besides asthma: leaving them high and dry is hardly ethical or fair.
As with the ongoing COX-2 controversy, patient education regarding the risks associated with their particular medication is the best course, be the medication for asthma or hemorrhoids. I, the case of COX-2 inhibitors, I know many patients who would choose having increased risk of an adverse cardiovascular event over dealing with the pain of their arthritis any day of the week. Thankfully, Celebrex is still on the market, and hopefully these respiratory drugs will remain available as well.
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[...] As a followup to last Wednesday’s post the panel assembled to ascertain whether or not Serevent, Advair, and Foradil should remain on the market voted unanimously to keep the three drugs available, citing an acceptable risk/benefit ratio. The panel also did not recommend any changes to the products or their packaging. This is good news for the estimated 20 million asthma sufferers in the United States. [...]
Pingback by polyscience.org » Advair, Serevent, and Foradil to remain on the market — July 20, 2005 @ 10:05 am