One Drug That Didn’t Make it…

It’s not often that the FDA turns down a drug.  It is more frequent that a drug does not get an expanded indication from its initial indication for use.  This is important because we as physicians can use any drug we want even if it is “off label.”  The “label” is that piece of indecipherable paper that used to come with many drugs, but now has been relegated to the internet in lieu of preprinted information sheets.

Some drugs are used off label simply because no one wants to do the study and the use is already common in practice.  Some are used off label because the study is being done and we don’t want to wait.  Probably 75% or more of coronary drug stent use is “off label,” as the patients that we treat are not similar to the patients in the studies used to approve the drugs.

The reasons that drugs are restudied after approval are that the drug reps who come to our offices can only talk about those uses for the drugs or stents that are tested and “indicated” even though more use may occur off label.  An example is the drug Provigil, which was approved for a very minor indication.  Its use soared when it became apparent that an effect of the drug was that it heightened concentration to allow people to stay up longer, and did not have the same side effects as other Neuro stimulants.

On January 13, 2010, the Cardiovascular and Renal Drugs Advisory Committee turned down adding a heart failure indication to nebivolol, a drug approved in the US for the treatment of hypertension.  The vote was 8-0 against it and the drug had already been denied by the FDA.  An aside…although the FDA has final say on which drugs and devices are approved, they rely on a panel of distinguished physicians to help guide them.  It is rare that a drug is turned down by the FDA that has been approved by the panel.  Sometimes the panel itself is a source of controversy if the participants are not upfront about their ties to industry.

This drug is approved for its use in heart failure in 71 countries.  Exactly what it was turned down for here and what happened here will be discussed in my next blog.

Tags: Coronary drug Stent, Hypertension, Provigil

This entry was posted on Thursday, February 4th, 2010 at 9:29 am and is filed under Aortic Aneurysms /Stents / Grafts, High Blood Pressure. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.