Bextra recall announced

The Food & Drug Administration (FDA) has finally did the right thing by announcing a recall of Bextra, a Cox-2 inhibitor drug manufactured by Pfizer. After months of speculation and fear that the drug industry will be able to push the FDA to leave a highly dangerous drug on the market, it seems that the FDA has come to its senses and has taken a decision that will ensure that only safe drugs are available to American people. (Related article: Bextra and Celebrex problems hurt Pfizer financially)

In an announcement this morning, the FDA has asked Pfizer to recall Bextra (or valdecoxib) from the market because the "overall risk versus benefit profile for the drug is unfavorable." A FDA panel had come up with a similar finding but since several members of the panel had financial ties to Pfizer, they had recommended that the drug stay on the market. It is common for the FDA to accept recommendations of such panels but due to conflicts of interest of members, there was almost a universal demand that the Bextra should be recalled.

Here is a brief history that led to the recall of Bextra:

September 30, 2004: Pfizer starts an aggressive marketing campaign for Bextra after Vioxx recall by Merck.

December 9, 2004: FDA announces that it is issuing a black-box warning on Bextra.

January 24, 2005: Public Citizen demands that FDA recall Bextra.

January 30, 2005: Kaiser Permanente, one of the largest HMO's in the US, bans Bextra.

February 17, 2005: Pfizer again claims that Bextra is a safe drug.

February 18,2005: FDA panel recommends that Bextra stay on the market with a black box warning.

April 7, 2005: FDA does not agree with Pfizer and the panel and asks Pfizer to recall Bextra

Even before Bextra recall announcement, Americans who have been hurt by Bextra have filed class action lawsuits against Pfizer. Today's recall announcement will result in an explosion of lawsuits against Pfizer in line with Vioxx class action lawsuits.

In a statement released by Pfizer, it says that "Pfizer respectfully disagrees with FDA’s position regarding the overall risk/benefit profile of Bextra. However, in deference to the agency’s views, the company has agreed to suspend sales of the medicine pending further discussions with the FDA." Pfizer said that it will explore options with the agency under which the company might be permitted to resume making Bextra available to physicians and patients. For now, Pfizer announced, patients should stop taking Bextra and contact their physicians about appropriate treatment options.

In addition, at the request of European regulators, Pfizer will also suspend sales of Bextra in the European Union. The company is in contact with other regulatory agencies around the world and will take appropriate measures based on those discussions. It is expected that withdrawal of Bextra will be worldwide.

In the same announcement, the FDA says that Celebrex will stay on the market with a blackbox warning and if Merck wants to resume sales of Vioxx, the FDA will review the application.

Related articles

Pfizer highlights risks of recall of Bextra

European drug regulators question safety of Bextra