TIMELINE OF EVENTS: ZELNORM
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July 2002 – Zelnorm is approved by the FDA for short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation.
2003 – Zelnorm’s popularity is being driven by an eye-catching advertising campaign in which women pulled up their shirts to reveal writing on their bellies. Thomas Ebeling, chief executive of Novartis’ drug division, said Zelnorm’s sales in the United States were closely tied to those commercials.
April 28, 2004—The FDA informs doctors about new labeling to warn about Zelnorm’s side effects risk – specifically, warnings about diarrhea and ischemic colitis. According to the FDA, several Zelnorm deaths were reported among patients with these conditions.
August 2004 – Zelnorm is approved by the FDA for men and women younger than 65 with chronic constipation.
2006 -- Driven by aggressive advertising, Zelnorm has $561 million in sales, up 34 percent from 2005. About 500,000 U.S. patients are taking Zelnorm.
January 2007 – Novartis scientists find a pattern of heart problems in data from all 29 of their Zelnorm studies.
February 22, 2007 – Novartis reports its findings to the FDA, which mobilizes a team of reviewers.
March 15, 2007 – The FDA team meets with Novartis officials to ask questions.
Thursday, March 29, 2007 – The FDA notifies Novartis that it has decided that Zelnorm should be withdrawn.
Friday, March 30, 2007 – Novartis complies with Zelnorm recall
| If you or a loved one has take Zelnorm and suffered from a heart attack or stroke,
contact us today. As one of the nation's premier pharmaceutical liability law firms, we represent consumers nationwide who have been victimized by defective pharmaceutical drugs and over-the-counter products, including Zelnorm.
Please feel free to contact us at 1-888-4-MEDLAW if you have questions or concerns. |
