Look Back at MedWatch Alerts – Have Products Gotten Safer This Year?

J0382654 When I began this blog back in February, I took a look at the increase in MedWatch alerts being issued by the FDA.  Here is what I said:

Since 2003, there has been a notable increase of 200% in output from the agency and nearly doubling the rate since last year.

In 2003 there were 108 MedWatch alerts.

In 2004 there were 160 MedWatch alerts.

In 2005 there were 300 MedWatch alerts.

Are drugs riskier or the agency more vigilant? Or is there another reason for this increase? Perhaps, but look for other visible surrogates that signal that the agency is appearing proactive rather than reactive.

I’ve gone back to see how 2006 is coming along because I had a feeling that things have slowed down.  I was right:

So far this year, there have been 104 MedWatch alerts.  At that rate, by year’s end, there we will return to 2004 levels from 2005 when we hit a record -in other words since last year, MedWatch alerts have been cut in half.  What gives?  Were there that many problems in 2005?

Have budget issues forced a cut in surveillance?

Was 2005 an anomaly?

Was there an increase in alerts in order to bolster confidence in the agency at a time when it was suffering a loss of confidence post-COX-2s? 

I don’t expect an answer to the question, but it is a curious observation nonetheless and one I wanted to share.

By the way, for those interested, the bulk of alerts have gone out under CDER with 51 on drugs, followed by devices with 41.  The balance were spread. 

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