Pfizer voluntarily withdraws Bextra®

Pfizer announces withdrawal - Pfizer announced today, April 7, the voluntary withdrawal of the popular COX-2 Bextra® (rofecoxib), which is used by millions for treatment of arthritis and acute pain.

The voluntary withdrawal of all strengths and dosage forms of Bextra® by Pfizer is based on the ongoing review of the non-steroidal anti-inflammatory (NSAIDs) drug class by the FDA. The FDA has concluded that the overall risk versus benefit profile is unfavorable and has requested that Pfizer, voluntarily withdraw Bextra® from the market. The FDA based their decision to suggest this withdrawal on three main factors:

• The lack of adequate data on the cardiovascular safety of long-term use of Bextra®, along with the increased risk of adverse CV events in short-term coronary artery bypass surgery (CABG) trials that the FDA believes may be relevant to chronic use.
• Reports of serious and potentially life-threatening skin reactions, including deaths, in patients using Bextra®. The risk of these reactions is unpredictable, occurring in patients with and without a prior history of sulfa allergy and after both short- and long-term use.
• Lack of any demonstrated advantages for Bextra® when compared with other NSAIDs.

Patients should be advised not to stop taking their medication before speaking with their physician about the potential implications of doing so. RxAmerica has already programmed its claims adjudication system to prevent claims for Bextra® from processing, and patients should be advised that depending on benefit design, other COX-2 medications may be available to them at a preferred copay.

RxAmerica is developing plan-specific impact studies and will provide each client with this information in no less than two business days.

Ensuring appropriate utilization - Please remember that RxAmerica has several programs already in place that helps ensure proper utilization of COX-2 medications as well as other drug classes. RxAmerica's web-based prior authorization tool, RxApprover™, helps physicians select drugs covered by the patient's prescription drug plan. RxAmerica's RxRewards™ program is designed to promote the use of the most effective agents in key therapeutic classes. Both of these programs help improve the quality of healthcare for members and reduce potential client spending in popular drug categories.

Patient return instructions - Patients who are currently using Bextra® should not stop taking medication before speaking with a physician about possible treatment alternatives. Currently, Pfizer is not issuing any instructions for credit or return of Bextra®. Representatives from Pfizer state that the drug is being temporarily withdrawn and they will not issue credits for medication until an official consensus is made with the FDA. We will be posting new information on our Web site as soon as we receive it.