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FDA Asks Pfizer to Withdraw Bextra Arthritis Drug, Cites Unfavorable Risk vs. Benefit Profile

Strategic Insights

— 1 min read

The US Food and Drug Administration (FDA) has requested that Pfizer withdraw its Bextra arthritis drug from the market, citing an unfavorable risk versus benefit profile. This decision comes despite Pfizer's hopes to consider resuming sales of its cox-2 painkiller, Vioxx, which was withdrawn in September due to safety concerns. The FDA also asked Pfizer to include a heart-risk safety warning on its Celebrex drug, and has requested that other makers of prescription anti-inflammatory pain drugs include a similarly strong warning. This move is a significant blow to Pfizer's three-year financial outlook, which was presented to Wall Street on Tuesday.

Key Takeaways:

  • The FDA has requested Pfizer to withdraw its Bextra arthritis drug from the market due to an unfavorable risk versus benefit profile.
  • The FDA has asked Pfizer to include a heart-risk safety warning on its Celebrex drug.
  • Other makers of prescription anti-inflammatory pain drugs are required to include a strong warning on their labels.
  • Merck, the maker of Vioxx, had its proposal to resume sales pending FDA approval.
  • Shares in Pfizer rose 0.14% to $26.90 in New York.
  • Moody's Investors Service has placed Pfizer's Aaa long-term debt ratings under review for possible downgrade.
  • Pfizer's guidance for the second half of this year, which included renewed interest and sales of Bextra and Celebrex, is likely to be changed.
  • Bextra and Celebrex sales were expected to halve this year from last year to $575m and $1.5bn, respectively.
  • The FDA's advisory committee said in February that both Bextra and Celebrex could stay on the market pending a decision, provided they carried strong warnings of increased heart and stroke risk.
  • European regulators have also requested Pfizer to suspend Bextra sales in the US.

Statistics:

  • Expected Bextra sales in 2005: $575m
  • Expected Celebrex sales in 2005: $1.5bn
  • Expected Bextra sales to halve in 2005 compared to 2004
  • Expected Pfizer earnings per share to increase by 10% in 2006 and 2007.
  • Pfizer's cost cuts by 2008: $4bn
  • Number of cox-2 inhibitor painkillers: 2
  • Percentage increase in Merck's stock price: 1.82%

Sources:

  • Financial Times Limited, Copyright 2005. All Rights Reserved.

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