Healthy Skepticism Library item: 11652
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
Associated Press.
FDA Asks Lilly to Stop A Cymbalta Mailer
The Wall Street Journal 2007 Oct 4
http://web.archive.org/web/20071012192234/http://online.wsj.com/article/SB119142704134747749.html?mod=googlenews_wsj
Notes:
Link to FDA Warning Letter:
http://www.fda.gov/CDER/warn/2007/Cymbalta_wl.pdf
Link to promotional material:
http://www.fda.gov/CDER/warn/2007/Cymbalta_promo.pdf
Full text:
INDIANAPOLIS — Eli Lilly and Co. has been asked to stop a Cymbalta promotion that makes misleading claims and understates risk, according to a letter sent to the drug maker by the Food and Drug Administration.
The letter said a mailer for the fast-selling drug overstates effectiveness and “omits some of the most serious and important risk information associated with its use.” The letter was posted on the federal regulator’s Web site. It asked Lilly to “immediately cease” disseminating the material.
The company is working with the FDA “to gain a greater understanding of their concerns,” Lilly spokesman Charlie McAtee said. Lilly will take action once it has “more clarity” on the agency’s comments, he said.
Cymbalta treats depression, diabetic nerve pain and general anxiety disorder.
The mailer promotes the drug’s use for diabetic nerve pain and states that those patients experienced “significantly less pain interference with overall functioning” when using the drug. The FDA letter noted that this “has not been demonstrated by substantial evidence or … clinical experience.”
The FDA also states that the mailer doesn’t reveal risks for patients with certain conditions and did not give precautions about liver toxicity, among other concerns.
Cymbalta, launched in 2004, has become a strong seller for Lilly. It registered $1.3 billion in sales last year, an increase of 94%. In the second quarter this year, only top-seller Zyprexa brought in more revenue than Cymbalta’s $519.5 million.
