Celebrex was the third in a family of popular prescription pain-relievers to be linked to a higher incidence of heart attacks. That followed the Sept. 30, 2004 removal of Vioxx from the market and the later revelation that Bextra also presented an increased health risk.
Kline & Specter, PC, previously handled litigation involving all three medications. The firm played a key role in the action that resulted in a $4.85 billion settlement by the makers of Vioxx. We are no longer accepting cases involving side effects of Celebrex.
The news concerning Celebrex, a top-selling medication used largely by arthritis sufferers and manufactured by Pfizer Inc., emerged from a study sponsored by the National Cancer Institute, which was testing the effect of Celebrex on certain tumors. What it discovered instead was that patients who took Celebrex were more than twice as likely to suffer heart attacks. (The cancer study was halted.) In a second study from 1999 -- but which only came to light recently -- elderly patients showed a fourfold risk of suffering heart attacks or strokes than patients who used a placebo.
The U.S. Food and Drug Administration on Aug. 3, 2005 finalized a "black box" warning for Celebrex, which had been taken by more than 26 million people.
Celebrex, Bextra (also a Pfizer product) and Vioxx, made by Merck & Co., are all COX-2 anti-inflammatory drugs. Merck withdrew Vioxx from the market after its own study showed that Vioxx patients suffered roughly twice the number of heart attacks and strokes. A deluge of lawsuits followed the drug’s withdrawal by people who claim to have suffered severe heart attacks and stroke, many of them represented by Kline & Specter.
Kline & Specter, PC, is a nationally recognized law firm with expertise in pharmaceutical and product liability litigation. The firm has some 30 lawyers, several of whom are also highly regarded doctors.
In the Celebrex test, patients took daily does of 400 and 800 milligrams to see if the drug could reduce certain tumors. But what the study discovered was that the patients using Celebrex had 2.5 times the risk of suffering a cardiovascular event as opposed to patients given a placebo.
Background: Celebrex, Vioxx and Bextra all work by inhibiting a protein called COX-2 that has been linked to inflammation. Celebrex and Vioxx were both introduced in 1999 and instantly became top-selling drugs for Merck and Pfizer, respectively. Pfizer, the world’s largest drug maker, introduced Bextra in the United States in 2001, also to robust sales.
"This does not bode well for COX-2 inhibitors in general," Ira Loss, an analyst at Washington Analysis, told the Reuters news agency.
While Merck removed Vioxx from the market, Pfizer has been reluctant to follow suit with its COX-2 products. The company had insisted after the removal of Vioxx that its Celebrex was safe and it has continued to advertise and market the drug.
The following is an article about the Celebrex study by Bloomberg News:
Dec. 17 (Bloomberg) -- Pfizer Inc. said its painkiller Celebrex, which is in the same class of drugs as Merck & Co.'s withdrawn Vioxx, increased the risk of heart attacks in a study. Pfizer shares plunged as much as 24 percent, wiping out about $41 billion in market value.
Patients in a U.S. National Cancer Institute study taking 400- milligram and 800-milligram doses of Celebrex daily had a 2.5 fold increase in their risk of a cardiovascular event compared with those on placebo, Pfizer said in a statement today. The institute suspended dosing of Celebrex in the study.
Regulators in the U.S. and Europe already are taking a closer look at the Cox-2 class of painkillers after Merck pulled Vioxx off the market Sept. 30 in the biggest withdrawal ever of a prescription drug. Pfizer Chief Executive Officer Hank McKinnell said as recently as Dec. 6 that there was no evidence Celebrex was dangerous. More than 27 million people in the U.S. have been prescribed Celebrex since its introduction in 1999.
"It's going to bring up the same issues as Merck with Vioxx, litigation risk and all the rest," said Sena Lund, an analyst with Cathay Financial in New York, who has an "outperform" on shares of New York-based Pfizer and owns them. "It's definitely not positive for the company, especially if they have to pull the drug."
No Plans to Withdraw
Pfizer officials couldn't immediately comment on details of the study beyond the information contained in the release, said Paul Fitzhenry, a company spokesman.
"Pfizer has no plans to withdraw Celebrex from market," Fitzhenry said.
The U.S. Food and Drug Administration and cancer institute also declined to comment immediately.
Pfizer, the world's biggest drug maker, said the negative finding from the NCI study was unexpected and inconsistent with other research. Pfizer shares fell $4.17, or 14 percent, to $24.81 at 11:37 a.m. in New York Stock Exchange composite trading, after dropping to $21.99. The decline was the biggest in at least two decades.
Public Citizen, a consumer group that monitors the FDA, has been preparing a petition asking the FDA to take Celebrex and Pfizer's Bextra, which is in the same class of drugs, off the market.
"They should come off the market and our petition will be filed in the next several weeks to ban both of these drugs," said Sidney Wolfe, the director of the Washington-based organization's Health Research Group.
The Vioxx withdrawal has prompted Congress to examine how the FDA monitors the risks of medicines. The Senate Finance Committee held a Nov. 18 hearing where FDA reviewer David Graham said the agency is incapable of protecting the U.S. against another drug with risks such as Vioxx.
Senate Finance Committee Chairman Charles Grassley intends to introduce legislation to make the FDA's Office of Drug Safety more independent. The committee oversees U.S. government health- insurance programs that pay for drugs, giving it a stake in the FDA's performance, Grassley said in November.
The House Energy & Commerce Committee, which oversees FDA, also have said they are scrutinizing the agency's performance.
Vioxx and Celebrex were supposed to be gentler on the stomach because they targeted the Cox-2 enzyme that is involved with pain. Older painkillers can cause stomach irritation by interfering with Cox-1, a related enzyme.
That difference was intended to justify the cost, sometimes more than $2 a pill, of these drugs, while generic painkillers sell for pennies each. Neither Merck nor Pfizer was able to prove that their painkillers were substantially different from older medicines, Wolfe said.
"The market sees a much larger risk today, not only about products in the pipeline but also products already on the market," said Stefan Ingildsen of BankInvest in Copenhagen, which manages about $9 billion and holds share of Pfizer. "There's very little incentive to invest in this sector at all at the moment."
The U.S. National Cancer Institute has been studying whether Celebrex might aid in preventing growths known as polyps that put people at risk for colon cancer. The heart risk findings were discovered during one of the trials. Another study, also intended to see if Celebrex can prevent some growths, found no increased heart risk for patients taking a 400-milligram dose of Celebrex compared with a group taking placebo, Pfizer said.
Celebrex is approved for use in the U.S. for the treatment of arthritis and pain, at recommended doses of 100 milligrams to 200 milligrams daily for osteoarthritis, and 200 milligrams to 400 milligrams a day for rheumatoid arthritis.
The FDA plans to hold an advisory committee meeting next year to review the safety of the Cox-2 painkillers.
Pfizer has already disclosed that its other Cox 2 painkiller, Bextra, is linked to an elevated risk of blood clots and heart attacks and strokes in cardiac surgery patients. The company on Dec. 9 said it would warn doctors of that risk. Bextra was one of five drugs that FDA reviewer Graham identified as unsafe at a Nov. 18 U.S. Senate hearing.
McKinnell said in an interview Dec. 6 that even if Bextra was found to have cardiovascular risks, he might not withdraw the drug.
"In the case of Bextra, I'm not sure that would be the right answer," he said in the interview. "A better approach may in fact be label for the known risks and let the physician decide what is the best drug for you given your personal circumstances."
Pfizer bonds weakened compared with government securities, as investors demanded a bigger yield premium to buy the debt. The so-called spread on the company's 4.5 percent notes maturing in 2014 widened about 7 basis points to about 45 basis points, traders said. A basis point is 0.01 percentage point.