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Area experts: Celebrex woes won't be felt much in Valley

Earlier warnings about similar drug spooked patients, doctor says.

By Joe McDermott
Of The Morning Call

December 18, 2004 - News that the top-selling painkiller Celebrex may increase the risk of stroke or heart attack if used in high doses is not likely to have much effect in the Lehigh Valley, say a local physician and pharmacist. Dr. Tom Meade, president of Orthopaedic Associates of Allentown, said many of his patients had switched from the cox-2 inhibitors that include Celebrex, Bextra and Vioxx after reports that Vioxx could increase the risk factors for heart attack or stroke.

Glenn Weiss, chief pharmacist at Hilbert's Pharmacy in Whitehall Township, said he was waiting for news that Celebrex, like Vioxx, could cause problems because it was in the same category. Celebrex, however, has been on the market much longer than Vioxx.

''I only had one phone call today. But once the news gets out, we'll probably get the same reaction we did with Vioxx,'' Weiss said. The Celebrex warning comes just two months after its one-time competitor Vioxx was pulled from store shelves for the same concerns. Celebrex is the most-prescribed drug for treating arthritis.

Meade said many of his patients went back to the cox-1 category that includes over-the-counter medications such as Advil, Motrin and Aleve, he said. ''Most of the people lost confidence in that class of drugs,'' Meade said, referring to the cox-2s. ''The real advantages for the cox-2s were for people who couldn't handle the cox-1s because of stomach troubles. But even the cox-2s had some gastric and ulceric side effects.''

Meade said many patients find more relief with Aleve or Advil or their prescription-strength equivalents.''We didn't have an overwhelming swell of people who went from Vioxx to Celebrex'' when the Vioxx risks were discovered, the orthopedic surgeon said. Weiss said that patients must realize that there are no medications without potential side effects — ''not even aspirin,'' he said — but he noted that many customers did switch from Vioxx to Celebrex. ''You have to weigh the risk versus the benefit in everything,'' Weiss said.

Meade said the study results also have to be considered. Vioxx studies found an increased risk for about 12 out of every 1,000 patients, but Meade said many of those patients are at an age where the risk of stroke or heart attack already exists. Meade said the onus is on the physician to remain educated and stay on top of the latest study results, especially when drug manufacturers and other medical suppliers are marketing directly to the consumer through broadcast and print ads.

joe.mcdermott@mcall.com
610-820-6533

Judge Sees Vioxx Lawsuit Lasting Rest of Decade

NEW ORLEANS (Reuters) - Apr 28, 2005 - The lawsuits against Merck & Co. Inc. for the alleged damages caused by its painkiller Vioxx were expected to last up to five years, the U.S. judge said on Thursday.

"I hope to get this entire litigation finished in four to a maximum of five years," said U.S. District Judge Eldon Fallon, who is overseeing nearly 500 lawsuits that have been filed against Merck.

Vioxx, which was withdrawn from the market in September after studies linked it to increased risk of heart attack and stroke, was prescribed to relieve the pain and inflammation of arthritis.

Merck, based in Whitehorse Station, New Jersey, maintains it acted responsibly.

Phillip Whitman, the attorney leading Merck's committee of defense lawyers said another 382 cases were waiting to be transferred to the federal court's jurisdiction.

"We're expecting 100,000 cases in this litigation," said Russ Herman, who is leading the attorneys on the plaintiffs' steering committee.

Furor Over Painkillers Alarms Patients

HACKENSACK, N.J. A rheumatologist is constantly on the phone trying to calm his patients. A doctor discovers his patients simply stopped taking their painkillers. And a retired welder wonders whether he will once again have to switch drugs to treat his arthritis.

The confusion that began three months ago when Vioxx was withdrawn from the market intensified over the past weeks with the halting of studies involving two other widely used painkillers Celebrex and Aleve. Federal regulators said the drugs showed an increased risk of heart problems.

And most recently, the Food and Drug Administration, in an attempt to clarify the recent data, recommended "limited" use of Celebrex and Bextra, another drug that recently showed increased heart risks. Both are in the same class as Vioxx, which was withdrawn after a clinical trial found it was linked to higher risk of heart attack and stroke.

Several physicians said that they were aware of the risks of Celebrex and Aleve long before the FDA advisory and do not intend to alter treatment plans for most patients. But the doctors worry about patients overreacting to the flurry of news.

"I've had an onslaught of phone calls from worried patients," said Dr. David Arbit, a rheumatologist at The Valley Hospital in Ridgewood, N.J., who treats about 120 patients a week. "Patients are confused and they don't know what to believe anymore."

Dr. Ralph Marcus said several patients without even consulting him stopped taking Celebrex and Aleve this week when they read the news accounts of potential cardiac risk associated with the medications. Marcus, chief of rheumatology at Holy Name Hospital in Teaneck, N.J., said he advised patients to resume treatment.

"I've told them based on one study I would not stop taking the medication," he said.

John Jenkins, director of the FDA's office of new drugs, said last week that the agency has not made a final determination about possible regulatory action regarding Celebrex and Bextra.

The agency called the advisory an "interim measure," pending further review of the data, and promised to hold a public meeting on the issue in February.

The FDA also advised consumers who use over-the-counter pain medications such as Aleve or ibuprofen, to strictly follow the label instructions, and to contact to their doctors if taking the drugs for more than 10 days.

For critics of the FDA, the confusion and controversy generated this week reinforces why there's "a sustained crisis in faith in both the pharmaceutical industry and in the regulatory system," said Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania.

On Dec. 17, the National Institutes of Health announced it halted use of Celebrex in a colorectal cancer trial that showed the drug more than doubled the risk of heart problems

Patients in the study taking 800 milligrams of Celebrex a day had a 3.4 times greater risk of heart problems than those taking placebos. For those taking 400 mg, the risk was 2.5 times greater. To confound matters, another ongoing study of Celebrex at 400 mg a day did not show an increased risk.

Patients in both studies were taking much higher doses than typically prescribed for osteoarthritis pain. The usual dose is 200 mg a day.

Calling the negative findings out of step with previous data, Pfizer Inc., Celebrex's maker, has not pulled the drug from the market, although it stopped its consumer advertising for Celebrex at the FDA's request.

Meanwhile, patients and physicians were left to sort out the information.

Frank Dudlo, a 60-year-old patient, had a checkup last week in Arbit's Fair Lawn, N.J., office. The doctor had recently switched the Clifton, N.J., man's prescription to Celebrex from Vioxx.

Dudlo, a retired welder who suffers from rheumatoid arthritis, called as soon as he heard news accounts of the study that questioned the safety of Celebrex.

However, Arbit assured him the drug is safe and Dudlo isn't about to give up a medicine that relieves the stiffness and severe pain of his arthritis.

Source: Columbian

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