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Drugs Pose Heart Attack Risk

Posted on: Tuesday, 25 January 2005, 18:00 CST

Pfizer Inc, the world's biggest drugmaker, should stop selling its Celebrex and Bextra painkillers immediately because they pose a risk of heart attacks, the consumer group Public Citizen told US regulators.

The Washington-based group, founded by Ralph Nader, filed a petition with the US Food and Drug Administration (FDA) urging the agency to take the medicines off the market on Monday. Merck & Co withdrew its Vioxx painkiller on September 30 because of heart risks. The FDA plans to examine painkiller safety at a meeting on February 16 to 18 in Gaithersburg, Maryland.

"Changing the package labelling to address this increased cardiovascular risk is not enough," the group said in the letter to FDA Acting Commissioner Lester Crawford. Public Citizen also asked that the FDA not approve Merck's newer painkiller, Arcoxia, and Novartis AG's Prexige pain medicine.

The FDA on December 23 urged doctors to limit prescriptions of Celebrex and Bextra, saying the Pfizer medicines should be reserved for patients who cannot tolerate the stomach side effects of older painkillers such as aspirin. Celebrex and Bextra were designed to inhibit the body's production of the Cox-2 enzyme, which is linked to pain and swelling.

FDA spokeswoman Kathleen Quinn said the agency would review the petition. Pfizer spokeswoman Susan Bro said she could not comment immediately.

Shares of New York-based Pfizer fell 22 US cents to US$24.26 as of 4:01 pm on Monday in New York Stock Exchange composite trading. Shares of Whitehouse Station, New Jersey-based Merck fell 34 US cents to US$30.02.

In the past 33 years, Public Citizen has petitioned the FDA to remove 25 drugs. Of those, 16 were pulled from the market and others were "severely restricted," according to the group. Nader has not held a position or served on the board since he left the organization in 1980.

More than 36 million prescriptions of Celebrex and Bextra were filled in the United States last year, Public Citizen said, citing IMS Health Inc, a pharmaceutical-information company based in Fairfield, Connecticut.

Celebrex and Bextra generated US$4.59 billion in worldwide sales for Pfizer in 2004. Pfizer acquired Celebrex and Bextra after buying Pharmacia Corp in April 2003.

"Longer term, that whole product category is damaged anyway now," said Jon Fisher, who helps manage about US$25 billion for Fifth Third Asset Management in Cincinnati, including Pfizer shares, on Monday.

While Pfizer has said it has no plans to withdraw Celebrex, it agreed to stop promoting the drug while US regulators evaluate data disclosed in December showing that higher doses of Celebrex increased the risk of heart attacks in a National Cancer Institute study of patients with colon polyps.

That study and another one involving Vioxx in people with colon polyps were conducted in patients with a level of cardiovascular risk equivalent to that in the general population, Public Citizen said on Monday.

"Both trials revealed statistically significant increases in cardiovascular events," the group said.

Source: China Daily; North American ed.

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