Are drug side effects getting worse, or are we just paying more attention [1]? There's no denying the numbers have gone through the roof; according to new research from the Institute for Safe Medication Practices, the FDA received reports of 89,842 adverse events including 15,107 deaths in 2005, more than double the 1998 numbers of 34,966 reports and 5,519 deaths.
The increase isn't due to an increase in drugs--adverse events grew four times as fast as prescriptions--nor to the blockbuster-drugs-gone-bad like Vioxx [2] and Bextra. It does relate to an increase in adverse reports from drug makers--not from doctors, who aren't required to report drug problems.
- check out this report [3] on the findings
- read the article [4] from the Wall Street Journal (sub. req.)
Related Articles:
Poll finds problems at the FDA. Report [5]
FDA offers safety reforms to skeptical lawmakers. Report [1]
IOM slams FDA, calls for major reforms. Report [6]
Pharmacovigilance grows in importance. Report [7]
Links:
[1] http://www.fiercebiotech.com/story/fda-offers-safety-reforms-to-skeptical-lawmakers/2007-01-31
[2] http://www.fiercebiotech.com/story/vioxx-defense-dealt-a-blow-by-new-study-results/2007-07-03?utm_source=related&utm_medium=internal
[3] http://www.fiercebiotech.com/press-releases/press-release-adverse-drug-events-reported-fda-appear-have-increased-markedly
[4] http://blogs.wsj.com/health/2007/09/10/more-drug-side-effects-or-just-more-reports/trackback/
[5] http://www.fiercebiotech.com/story/poll-finds-problems-at-the-fda/2006-07-21
[6] http://www.fiercebiotech.com/story/iom-slams-fda-calls-for-major-reforms/2006-09-22
[7] http://www.fiercebiotech.com/story/pharmacovigilance-grows-in-importance/2006-01-03