FDA panel supports return of Vioxx

posted on:
February 21, 2005

author:
Julie Schmit and Kevin McCoy

A Food and Drug Administration (news – web sites) panel’s support for Vioxx, Celebrex and Bextra is good news for Merck and Pfizer, but restoring consumers’ confidence in the three COX=2 painkillers might be tougher.

The panel recommended Friday that the FDA (news – web sites) support the return of Merck’s Vioxx to market and that Pfizer’s Celebrex and Bextra remain available despite some cardiovascular risk. The vote indicates the panel found that the drugs’ benefits for some patients outweigh their risks. The FDA typically follows its panels’ advice.

Still, the outlook for COX-2 drugs remains difficult. “The whole category is damaged goods,” says Barbara Ryan, drug industry analyst for Deutsche Bank.

Deutsche expects sales of Celebrex, at $3.3 billion last year, and Bextra to fall 50% this year from last. “These drugs will be a shadow of their former selves,” agrees Robert Hazlett, of SunTrust Robinson Humphrey.

Merck took Vioxx off the market Sept. 30 after a study showed increased heart risk in people taking the drug for 18 months. Pfizer stopped direct-to-consumer advertising of Celebrex in December after a study showed it also posed cardiovascular risks. The surprising Vioxx vote also could improve Merck’s position in hundreds of lawsuits alleging that Merck withheld information about Vioxx’s risks. Merck denies that.

“It’s not a favorable development for either the litigation or the public,” says Paul Sizemore, a plaintiffs attorney, of the panel’s recommendation.

Merck shares rose 13% Friday to $32.61 after the panel voted 17-15 in favor of Vioxx’s return. Pfizer shares rose 7% to $26.80. Celebrex got the strongest endorsement, 31 to 1 in favor of keeping it on the market, as long as it carries a stronger warning. Bextra has a bold type warning about severe skin reactions.

Merck’s shares, even after Friday’s bump, are still 27% below where they were before Vioxx’s recall; Pfizer’s shares are off 10%. Merck wouldn’t say Friday what it’ll do, but it said the day before that Vioxx might return if the FDA supports it. Vioxx sales hit $2.5 billion in 2003.

If Vioxx sales resume, the drug would likely carry a stronger safety warning, experts say. Still, a Vioxx return would help Merck earnings, says Hazlett, who upgraded his rating on Merck shares Friday.

“Vioxx is still being singled out,” said Christopher Seeger, a New York attorney whose firm has filed more than 100 Vioxx cases. He noted that the panel’s support was narrower for Vioxx than for Celebrex and Bextra. “If you were a doctor, would you prescribe it?”

Free Legal Consultation
At Beasley Allen, there is never a fee for legal services, unless we collect for you. Contact us today by filling out a brief questionnaire, or by calling our toll free number, 1-800-898-2034, for a free, no-cost no-obligation evaluation of your case.
back to top