NY Times Examines FDA, J&J Actions Leading To Removal of Heartburn Medication

Main Category: Pharma Industry / Biotech Industry
Article Date: 12 Jun 2005 - 0:00 PDT

email to a friend   printer friendly   opinions  

The New York Times on Friday examined the history of Propulsid, a... Johnson & Johnson heartburn medication the company removed from the U.S. market in 2000. The Times reports that newly released corporate and government documents provide "an in-depth view of a pharmaceutical company trying to save a lucrative drug in the face of growing evidence of harmful side effects." In 1998, Propulsid sales were more than $1 billion, with about 20% of infants in neonatal care units given the drug as a treatment for acid reflux. Later that year, after FDA raised concerns over the drug's efficacy in pediatric patients in clinical trials, FDA and J&J negotiated changes to warnings on the drug's label. However, the changes were "not nearly as tough as regulators would have liked," the Times reports. By January 2000, FDA had reports of 80 deaths and 341 serious heart problems in patients taking the drug. Three weeks before an FDA hearing in which an outside expert panel was to discuss the safety concerns, J&J announced it would remove the drug from the U.S. market (Harris/Koli, New York Times, 6/10).

New York Times

"Reprinted with permission from kaisernetwork.org kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

• Additional
• References
• Citations