Do they or don't they? The feds aim to find out whether drugs for attention deficit hyperactivity disorder actually increase the risk of heart problems. The FDA and the Agency for Healthcare Research and Quality will review clinical data on 500,000 patients who took ADHD meds over a seven-year period ending in 2005, looking for any patterns that indicate the patients also developed high blood pressure or other cardiovascular problems.
This new study stems from concerns raised at an FDA advisory committee meeting last year, when the panel recommended stronger warnings [1] for the drugs because of potential cardiac risks. The FDA then began its own research, but budgetary constraints threatened its completion. Americans spent about $1.5 billion last year on the three top ADHD drugs: Concerta [2] (Johnson & Johnson), Strattera [3] (Eli Lilly), and Adderall [4] (Shire).
- read the statement [5]Â from the FDA
- check out this Los Angeles Times article [6]
Related Articles:
FDA committee votes against ADHD "black box." Report [7]
FDA panel wants 'black box' on ADHD drugs. Report [1]
FDA committee to review ADHD risks. Report [8]Â
Links:
[1] http://www.fiercebiotech.com/story/fda-panel-wants-black-box-on-adhd-drugs/2006-02-10?utm_source=related&utm_medium=internal
[2] http://www.fiercebiotech.com/story/regulators-ponder-response-to-concerta-complications/2005-06-29
[3] http://www.fiercepharma.com/story/lilly-beset-potential-strattera-imitators/2007-08-31
[4] http://www.fiercebiotech.com/story/shire-impax-settle-adderall-xr-dispute/2006-01-20
[5] http://www.fiercebiotech.com/press-releases/fda-statement-ahrq-and-fda-collaborate-largest-study-ever-possible-heart-risks-adhd-m
[6] http://www.latimes.com/features/health/la-na-adhd18sep18,1,3806935.story?coll=la-headlines-health&ctrack=5&cset=true
[7] http://www.fiercebiotech.com/story/fda-committee-votes-against-adhd-black-box/2006-03-23?utm_source=related&utm_medium=internal
[8] http://www.fiercebiotech.com/story/spotlight-fda-committee-to-review-adhd-risks/2006-02-02