Safety of Bextra questioned by Senate

Many people who have been injured by Vioxx have had to find alternatives to the drug since the recall of Vioxx in late September. The two drugs that doctors have rushed to prescribe are Celebrex and Bextra, both of which belong to the Cox-2 category. There is conflicting data at this time if these two drugs are safe, though there is evidence that Vioxx was the most dangerous of them all. The German authorities are so concerned about the safety of Cox-2 drug that they have severely limited how these drugs are prescribed.

In the United States, however, Celebrex is being marketed without any warning at all (many Vioxx victims that have written to us do not fully understand what is meant by Cox-2 inhibitor drugs) while Bextra now carries a much stronger warning about its adverse side effects.

Sen. Chuck Grassley, Chairman of the Senate Finance Committee, is now asking the Food and Drug Administration to explain how it has evaluated the risks associated with the painkiller Bextra and made decisions about the agency's regulatory response. Grassley's request for information follows the announcement by Pfizer that doctors will be warned about Bextra's cardiovascular risk and be given stronger cautions about the drug's possible effect on the skin. (Related article: Changes needed in drug approval process after Vioxx scandal)

The lead witness, Dr. David J. Graham, at an oversight hearing held in November by Grassley warned of problems with Bextra and four other drugs on the market today, about which Grassley said he will also ask the FDA for information. The panel examined the actions of the Food and Drug Administration before Vioxx was pulled from the world market in September by Merck. The senator said today that his letter to the acting administrator of the Food and Drug Administration is part of what will be a sustained effort to restore greater public confidence in the federal government's food and drug safety agency. "When the FDA approves a drug, you should be able to bank on it," he said. "If a drug isn't safe, you should know the FDA will take it off the market." (Related article: Vioxx critic may lose his job for criticizing FDA)

In addition to questioning the Food and Drug Administration about Bextra, Grassley said he will ask Bextra's maker, Pfizer Inc. for information about its decision to make the labeling changes and its communication with the FDA about the drug's cardiovascular risks. In conjunction with his oversight work, Grassley is pressing for reforms – both legislative and administrative – to bring about greater responsiveness and transparency at the Food and Drug Administration. The senator said he will introduce legislation early next year to establish an independent office of drug safety in the Food and Drug Administration. "The office that reviews the safety of drugs that are already on the market should not in any way be under the thumb of the office that put the drugs on the market in the first place, which is what we have today as a practical matter." Grassley said he is also looking at legislation to establish a clinical trial registry for drug companies to make more information available to the public regarding pharmaceutical drugs on the market. (Related article: Vioxx scandal shows how FDA became toothless)

In a letter to Lester M. Crawford, Acting Commissioner of the FDA, Grassley is asking very tough questions and is directing the FDA to send complete set of documents related to Bextra so that the Senator's office can review if the FDA has taken all the steps necessary to secure the safety of the drug. He has also asked about other drugs with serious safety problems: Meridia, Crestor, Accutane, Bextra and Serevent. These drugs are being taken by Americans with no warning at all at this time though Dr. Graham had testified before the Committee that they were potentially as dangerous as Vioxx.

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