Location:

2224 1st Avenue North
Birmingham, Alabama 35203

Main:  (205) 326-3336
Fax:  (205)-326-3332
Toll Free:  1-800-241-9779

Mailing Address:
Post Office Box 11310
Birmingham, Alabama 35202

If you or a member of your family took Bextra, you should be aware of the information above and these additional points:

The FDA based its April, 2005, finding of Bextra’s unfavorable risk profile on the potential increased risk for serious cardiovascular (CV) adverse events. That risk, according to the FDA, appears to be a class effect of non-steroidal anti-inflammatory drugs (NSAIDs) (excluding aspirin).

According to the FDA, Bextra has been shown to be associated with an increased risk of serious adverse CV events in two short-term trials in patients immediately post-operative from coronary artery bypass graft (CABG) surgery.

The FDA has concluded that it is reasonable to extrapolate the adverse CV risk information for Bextra from the short-term CABG trials to chronic use given the fact that other COX-2 selective NSAIDs have been shown in long-term controlled clinical trials to be associated with an increased risk of serious adverse CV events, and the well-known risk of serious, often life-threatening gastrointestinal bleeding.

Other reasons for the withdrawal of Bextra are an increased risk of serious skin reactions – namely:

• toxic epidermal necrolysis
• Stevens-Johnson Syndrome
• erythema multiforme

Bextra has not shown unique advantages over other available NSAIDs.