Forest Laboratories Inc. received a warning letter from the FDA near the end of August for failure to show the risks of its high blood pressure medication, Bystolic [1], when promoting the drug to physicians.
The company ran an eight-page ad in a variety of medical journals favorably comparing the medication to other medications, but without enough research to support their claims. The advertisements omitted and minimized some of the risks associated with the drug--including cardiac failure and chest pain, as well as claimed the drug was superior for use in patients with obesity, diabetes and poor metabolism--without sufficient evidence to do so, according to the FDA.
Share prices also dropped following legal claims on the Bystolic patent.
- catch the Forbes.com story [2]
- read the Pharmalot blog post [3]
Related Articles:
New "me-too" beta blocker dissed by experts [4]
Forest Labs gets Lexapro protection [5] (Sept 2007)
Forest to pay Mylan $75M for nebivolol rights [6] (Jan 2006)
Forest Labs reports Phase III failure for fibromyalgia drug [7] (Sept 2005)
Links:
[1] http://www.fiercebiotech.com/special-reports/bystolic-2007-fda-approvals
[2] http://www.forbes.com/feeds/ap/2008/09/04/ap5390226.html
[3] http://www.pharmalot.com/2008/09/fda-warns-forest-labs-over-bystolic-ads/
[4] http://www.fiercebiotech.com/story/new-me-too-beta-blocker-dissed-experts/2007-12-19
[5] http://www.fiercepharma.com/story/forest-labs-gets-lexapro-protection/2007-09-06
[6] http://www.fiercebiotech.com/story/forest-to-pay-mylan-75m-for-nebivolol-rights/2006-01-12
[7] http://www.fiercebiotech.com/story/forest-labs-reports-phase-iii-failure-for-fibromyalgia-drug/2005-09-29