FDA Panel Votes to Keep Painkillers on the Market

Pharmacy Times, Volume 0, 0

The popular painkillers Vioxx,Celebrex, and Bextra will in all likelihoodbe available for patients whoneed them. An FDA advisory panelrecently voted to keep all 3painkillers, known as cyclooxygenase-2 inhibitors, on the market. Thedecision came after a 3-day meetingto discuss their safety. Because thepanel agreed that all 3 drugs posedcardiovascular risks, they said thatthese drugs must be used under strictwarnings and scrutinized supervision.

The panel was in favor of blackbox warning labels, the highest levelof warning at the FDA. The labelswill alert patients that these drugscan help but cannot be taken lightly.The panel voted 17 to 15 to keepMerck & Co Inc's Vioxx (rofecoxib)on the market. In September 2004,Merck voluntarily withdrew its arthritisand acute pain medication fromthe market. The company's decisionwas based on new, 3-year clinical datafrom a prospective, randomized,placebo-controlled trial, the APPROVe(Adenomatous Polyp Prevention onVioxx) trial. The study showed anincreased risk for confirmed cardiovascularevents (ie, heart attack,stroke) beginning after 18 months oftreatment in the patients takingVioxx, compared with those takingplacebo. Merck spokesman ChristopherLoder said that the company willdiscuss with FDA officials any actionsit needs to take in order to resumeselling the drug.

Since Vioxx's withdrawal, studieshave associated Pfizer's Celebrex(celecoxib) and Bextra (valdecoxib)with the same risks. The panel voted31-1 to keep Celebrex on the marketand 17-13 for Bextra (with 2 panelmembers abstaining). Analysts hadprojected that the heart attack andstroke risk associated with Celebrexmight lead the panel to recommenda black box warning. Bextra alreadycontains a black box warning.

Pfizer will work with FDA officialson Celebrex's new label. The companyalso plans long-term studiesabout the heart safety of both drugs,according to Pfizer spokeswomanSusan Bro.