Healthy Skepticism Library item: 14396
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
 
Publication type: news
Mirapex Subject of DDMAC Warning Letter
FDAnews Drug Industry Daily 2008 Oct 6
http://www.fdanews.com/newsletter/article?issueId=12019&articleId=111010
Abstract:
Boehringer Ingelheim disseminated consumer and professional advertising for its Mirapex treatment for restless leg syndrome (RLS) that failed to include risk information and effectively broadened the drug’s indications, according to an FDA warning letter.
Notes:
Link to warning letter:
http://www.fda.gov/CDER/warn/2008/Mirapex_WL.pdf
Link to promotional material:
http://www.fda.gov/CDER/warn/2008/Mirapex_Promo.pdf