Thursday, March 20, 2008

Spiriva and Stroke-FDA's warning may be too much (or too soon) information

As best I could tell, wading through the big-pharma disseminated information and infomercials and what also sounded reasonable, and with a desire to try and make COPD patients breath a little better, Spriva (tiopropium) seemed a worthwhile improvement over the then available other medication in that category for the treatment of COPD. Once a day is better than twice a day if only for the fact that folks are more likely to use the medications as intended. Its anticholinergic ancestor, ipratropium or Atrovent was taken twice a day.

Now we are warned about possible an increase risk of stroke in Spiriva users. Dr. Matthew Mintz in his blog give us a good perspective of this breaking news and gives a good explanation of what sort of data the FDA looked at and what information is likely to come down the pike in a reasonably short length of time that might mitigate the worry generated by what might be described "as too much information" or at least maybe "too soon information". Data from a 4 year study called "Uplift" is said to be available in June.

A pet ranting topic of mine has been the issue of the small relative risk which I talked about here.

Could the FDA have waited until June to sound the alarms if they needed to at all.With their recent history of Avandia and Vioxx they probably can't win and will get flak whatever course they take. Being an expert is not easy anymore and epidemiology is not for sissies.

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