- The Washington Times - Friday, December 17, 2004

Celebrex, the nation’s best-selling painkiller, raises the risk of heart disease, the federal government said yesterday, the same problem that led to the withdrawal of its competitor Vioxx.

Its manufacturer, New York pharmaceutical giant Pfizer Inc., said it would not recall the arthritis drug, a spokeswoman said yesterday. She would not comment further.

As of Sept. 30, more than 27 million U.S. patients had been prescribed Celebrex, though that number jumped significantly after Vioxx was pulled from pharmacy shelves, the company said.

The announcement comes 10 weeks after Merck & Co. Inc. voluntarily recalled Vioxx, the nation’s second-largest painkiller. A report found the drug doubled the likelihood of heart attacks and strokes in patients taking it to prevent colon polyps that cause cancer.

Yesterday, the government suspended the use of Celebrex in a study after a report found patients on the drug had an increased risk for heart attacks and strokes.

The National Cancer Institute, which sponsored the Celebrex trial, also stopped the use of Celebrex in 40 other clinical trials.

Shares of Pfizer, a component of the Dow Jones Industrial Average, dropped 11 percent on the New York Stock Exchange to $25.75, down $3.23 from Thursday’s closing price of $28.98.

The long-term Celebrex trial had patients on daily doses of 200 milligrams, 400 milligrams and 800 milligrams to prevent colorectal cancer.

Patients on the 200-milligram dose had a 250 percent higher risk of heart attacks and strokes compared with those on placebos, according to the institute’s independent Data Safety and Monitoring Board.

Patients taking 400 milligrams per day during the 33-month trial had a 340 percent increased risk for cardiovascular problems, said Dr. Ernie Hawk, director of the National Cancer Institute. He did not say how much the risk increased for the 800-milligram daily dose.

A separate cancer study found no increased heart risks for patients taking 400 milligrams of Celebrex per day, the monitoring board reported.

“These clinical results are new. The cardiovascular findings in one of the studies are unexpected and not consistent with the reported findings in the second study,” Pfizer Chairman and Chief Executive Hank McKinnell said yesterday in a Securities and Exchange Commission filing.

The Food and Drug Administration, which approved Celebrex for osteoarthritis and rheumatoid arthritis in 1998, said it was evaluating the information and would make an announcement in the next few days.

FDA Acting Commissioner Dr. Lester Crawford said the agency “is leaving all regulatory options open” at this point, including a mandated recall of Celebrex and a black-box warning required on the label. The agency also is investigating if it should withdraw all Cox-2 inhibitor drugs from the market, he said.

Dr. Crawford advised patients using Celebrex and doctors prescribing the drug to consider using other arthritis medicines or the lowest dose of Celebrex if necessary.

Additionally, the National Institutes of Health is conducting a full review of all studies involving drugs that work like Celebrex.

Several analysts downgraded their profit expectations and stock ratings for Pfizer after the announcement.

Adam Greene, an analyst with Albany, N.Y., investment bank First Albany Capital, dropped his rating from a “strong buy” to “neutral” because of yesterday’s announcement.

“While we had been cautious already on the Cox-2 [inhibitor] market in light of Vioxx, this news is likely to significantly impact market growth,” he said.

Mr. Greene does not own any Pfizer stock, and First Albany has no banking relationship with the company.

David Risinger, an analyst with New York investment bank Merrill Lynch, lowered his earnings-per-share outlook but said he expected Pfizer to keep selling Celebrex. “We do not believe Pfizer will pull Celebrex or [painkiller] Bextra from the market,” said Mr. Risinger, who rated the company as “neutral.”

He forecasted the company would make $2.5 billion in 2005 sales instead of $3.9 billion. Mr. Risinger also reduced earnings per share for the year to $2.14 from $2.26.

Mr. Risinger does not own any shares, but Merrill Lynch is seeking business with Pfizer.

Merck spokeswoman Anita Larsen had no comment on Pfizer’s drug yesterday. The company continues to work on three large trials for its newer arthritis drug, Arcoxia, which works like Vioxx.

The studies, which will determine if Arcoxia also increases the risk of heart attacks and strokes, are expected to show results in 2006.

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