New Jersey Saleswoman Sentenced for Off-label Promotion of Bextra

 

A New Jersey judged fined a Bextra sales manager $75,000 and sentenced her to 24 months of probation for distributing a misbranded drug. The woman was using off-label promotions to sell Bextra to doctors and patients all over her sales region.

In 2001, the Food and Drug Administration approved Bextra for use against arthritis pain. In 2005, the FDA and European regulators asked the makers of Bextra, Pfizer, Inc. to discontinue selling the dangerous drug. After research was conducted, Bextra had been linked to a high rate of heart attacks and other cardiovascular side effects. Pfizer attempted to get Bextra approved for use against acute pain, but the FDA was concerned about the safety of the drug’s use in this area. The FDA denied Bextra for use against pain after surgery as well as for other pain.

During the time period of November 2001 through April 2005, the drug sales manager sold, and encouraged nearly 100 employees beneath her to sell Bextra through any means possible. The woman told doctors and patients that the drug could be taken before, during, and after surgery to help prevent deep vein thrombosis. The drug had never been approved for such use, and there was no research suggesting it could help patients for this.

The woman also promoted Bextra for use after surgery to help with recovery pain; the exact thing the FDA denied. This dangerous off-label promotion could have put thousands of people at unneeded risk of side effects caused by taking Bextra in an unapproved way.