Kaiser Permanente Drops Bextra
2/01/2005
Editor's note: For the official SAA Position Statement on the COX-2 Inhibitors (Vioxx, Celebrex, Arcoxia, Bextra) please click here.
Citing concern over possible increased cardiovascular risk when taking the drug Bextra, Kaiser Permanente has stopped prescribing Bextra and will continue to do so until the drug is shown to be safe.
Kaiser, the nation's largest not-for-profit managed-care provider, plans to stop filling new prescriptions for Bextra on Feb. 1 and on March 1 for refills.
The FDA issued two new warnings on Bextra in December of 2004 for cardiovascular risks as well as a "boxed" warning for possible serious skin reactions, including Stevens Johnson Syndrome.
This news comes after two other similar drugs in the same class as Bextra, (the COX-2 Inhibitor class of non-steroidal anti inflammatory drugs) have seen similar scrutiny. Vioxx was pulled from the market in September of 2004 by its maker, Merk & Co., because of increased cardiovascular risks associated with the drug. In December of 2004, a study by the National Cancer Institute (NIC) called the Adenoma Prevention with Celecoxib (Celebrex) was suspended when it showed that patients taking 400mg and 800mg of Celebrex daily had an approximately 2.5 fold increase in their risk of experiencing a major fatal or non-fatal cardiovascular event compared to those patients taking placebo.
This action represents the first time that Kaiser Permanente's doctors had decided to stop dispensing a drug that was approved by the Food and Drug Administration.