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FDA, Pfizer Pull Support for Bextra

Posted on: Saturday, 9 April 2005, 00:00 CDT

The Food and Drug Administration and the drug company Pfizer are telling patients to stop taking Bextra, a drug prescribed by doctors to relieve arthritis pain and inflammation.

Thursday, the FDA cited a lack of adequate data on the increased risk of cardiovascular events related to long-term use of the drug and potentially life-threatening skin reactions as reasons for asking Pfizer to pull the drug from the market.

In a Web-site posting, Pfizer said it "respectfully disagrees" with the FDA's position regarding Bextra and would like to explore options about working with the agency to resume making the drug available to patients.

The FDA also announced it had asked Pfizer to place a boxed warning on Celebrex, another prescription drug used to treat arthritis, which, like Bextra, is a cox-2 inhibitor.

The government agency also asked other manufacturers of prescription and over-the-counter nonselective nonsteroidal anti- inflammatory drugs (NSAIDs) to place warnings that

highlight the risk of heart events and serious, possibly, life- threatening gastrointestinal bleeding associated with their use.

Over-the-counter medications that can be used for long-term pain include naproxen, known by the brand name Aleve, and ibuprofen, known by the brand name Motrin. They also may be used for short- term conditions such as menstrual cramps, sprains and back pain. Those uses does not fall under the recent warning. Searching for alternatives

Some believe this new round of warnings and the withdrawal of Bextra, following a withdrawal of Vioxx from the market last year, has limited the number of drugs available to patients with arthritis pain. They say warnings on those over-the-counter medications will further discourage patients from taking the drugs.

"What I'm seeing is no matter which way you look, as a patient, as a doctor, as an advocate, we're all sort of reeling about what are our alternatives," said Dr. Elizabeth Tindall, president of the American College of Rheumatology.

Patients who had been taking Bextra or one of the NSAIDs may be frightened, worrying that without the medication they might not be physically able to get out of bed, get dressed and carry on with their day, she said.

Tindall, who practices in Oregon, said through the years, some of her patients have had heart attacks or strokes while taking the drugs, but it's hard to know if the drugs were the cause. In some cases, patients smoked cigarettes or had other risk factors, she said.

With Bextra being pulled, many doctors probably won't prescribe Celebrex because the drugs are in the same class, she said.

Tindall said with the number of medical malpractice cases being filed, doctors will worry about getting sued, adding lawsuits against drug companies will increase, too. Insurance companies already had placed pressure on doctors not to prescribe Celebrex because of its cost, she said.

William Kautz, pharmacy manager at Memorial Hospital, said he feels bad for the patients who now have to sort out conflicting messages from drug companies and the FDA.

"If you carve all those away, you are really left with nothing but Tylenol or Tylenol products," he said. "It really is a huge problem with patients who have rheumatoid or osteoarthritis."

The NSAIDs do more than Tylenol products because they reduce inflammation, which is the source of pain in a person whose joints swell, Kautz said. Tylenol products don't treat the root of the arthritis problem, he said.

Kautz said when patients learn their drug has been pulled, they get concerned, even if they never had a problem. Others want to keep taking the drug because they believe it helped them, he said.

After Merck & Co. removed Vioxx from the market, patients told Kautz they wished they could still take the medication.

Memorial Hospital never saw any adverse drug reactions from patients taking Bextra, Kautz said. Being informed

Catherine Penrod, president and CEO of the Arthritis Foundation, Central Pennsylvania Chapter, which covers 28 counties including York, said her organization encourages patients to talk to their doctors to assess their risks.

"A lot of the confusion around prescription drugs has to do with information that comes out that people don't understand," she said. "It really comes down to personal decisions."

She stressed patients should consider getting a second opinion if they believe they shouldn't be taking a drug, and they also should learn about pain management.

Penrod said putting warnings on those over-the-counter medications is a good thing because it will help patients evaluate their personal risks.

And no drug is without side effects.

When doctors prescribe newer drugs, they run the risk that the drug may be pulled later as more studies are completed, said Dr. John Wolfe Blotzer, program director of the internal medicine program at York Hospital.

"Usually, when (new medications) come out, we don't know what the long-term complications will be," he said.

Blotzer, who is one of the hospital's rheumatologists, said he waited about a year before he started prescribing Celebrex after it first hit the market, then decided that older drugs, such as naproxen and other pain medications, including opiates, worked just as well with fewer side effects.

Celebrex didn't protect the stomach from ulcers but is still on the market. Vioxx did but was found to increase cardiovascular events. Now Bextra also has been pulled for the cardiovascular risks.

"I think at this point, there is no compelling reason to use any of these drugs until we know more," he said.

Reach Jennife

Reach Jennifer Nejman at 771-2026 or jnejman@ydr.com.

Source: York Daily Record

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