I am glad right now that the only thing I am suffering from is a common head cold, thanks to my two toddlers wanting to “share.” If I had arthritis like my grandmother did, I would really be starting to worry. It seems that even after the talk of using “black box warnings” from this past February’s hearings at the FDA, today, the FDA asked Pfizer to pull Bextra (valdecoxib), another beleaguered Cox-2 inhibitor, from the market today as part of a broad-ranging Public Health Advisory on the entire class of NSAIDs.

In making this announcement, the FDA cited inadequate information on possible heart risks from long-term use of the drug as well as “life-threatening” skin reactions, including deaths. The regulatory agency also called for the strongest warning possible on Pfizer’s other arthritis product, Celebrex. These decisions come about six months after rival drugmaker Merck & Co. pulled its blockbuster arthritis drug Vioxx off the market, also due to safety concerns.

In calling for a stronger warning on Celebrex labels, the FDA cited increased risk of cardiovascular “events” and gastrointestinal bleeding and said all similar drugs should have label warnings.

Pfizer said it “respectfully disagreed” with the FDA decision and it plans to hold talks with the agency about returning Bextra to the market.

What is particularly interesting in this case is that the FDA went against the advice of a panel of doctors and scientists, which in February concluded that Bextra was beneficial enough to justify its sale. Bextra, generated $1.29 billion in sales for New York-based Pfizer last year, 2.4 percent of total revenue. Celebrex brought in $3.3 billion, or 6.3 percent.

Cox-2 Class

Celebrex, Bextra and Vioxx are part of a class of drugs known as Cox-2 inhibitors. The medicines are designed to target the body’s production of Cox-2, an enzyme linked to pain and swelling, while sparing a related enzyme that helps protect the stomach from complications such as ulcers and bleeding. They sold for as much as $2 a pill, compared with pennies for generic painkillers such as aspirin.

Like the Merck drug Vioxx, the two Pfizer drugs are COX-2 inhibitors that work to prevent the internal bleeding associated with drugs like aspirin. Merck withdrew Vioxx last fall after studies showed it had twice the risk of heart attack and stroke compared with patients who took a placebo for 18 months. In a statement, the FDA also said it would “carefully review” any proposal to put Vioxx back on the market.
Bextra already carried a warning highlighted in a black box on its label about its link to skin reactions. One of those reactions, known as Stevens-Johnson, may cause a rash, blisters or red splotches on the skin and persistent fever. The FDA determined that the skin and cardiovascular risks together were enough to justify the drug’s withdrawal.

“No added advantage and a special risk is what led us to the change with Bextra,” Steve Galson, acting director of the FDA’s center for drug evaluation and research, said on a conference call.

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3 Comments

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    Isn’t it a classical case of pharmaceutical companies gouging the patients on false promises and claims? COX-2 inhibitors were introduced with the explicit claims that they do not carry the risk of gastric bleeding like common NSAIDs and are better performing. The PR departments of these companies bring on TV a couple or few patients and show-case them as the living proof of their ‘better’ product. There are hundreds of remedies out there that works like a magic for certain patients but they do not become a ‘celebrity’ and do not make billions. Now, we are dealing with not only the gastric bleeding but also the added risks of other potentially fatal diseases. Nevertheless, these companies have already made billions in profits at the expense of patients. Our age-old Aspirin is still a champion in this arena if used properly and is dirt-cheap.

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    The pharmo-medical industries has got this entire planet fixed into the medical matrix of drugs as the cure for disease. I escaped the medical matrix several years ago and I just shake my head at the Brave New World that has been created in my lifetime. I will be blunt: THERE IS NOT A SINGLE DRUG ON THIS PLANET THAT IS GOOD FOR ANYTHING!!!! EVERY , E-V-E-R-Y!!!!! DRUG IS A POISON TO THE BODY!!!!!!! EVERY DRUG DAMAGES THE BODY. ALL ILLNESSES CAN BE CURED WITHOUT DRUGS. IN FACT, NO ILLNESS CAN BE CURED BY ANY DRUG!!!! When you study and apply natural healing techniques, which truly work, you begin to realize the madness of modern medicine. It reminds me of that scene in Star Trek 4, when Kirk & Bones are rescuing Chekov from a hospital back in the 20th Century, and Bones overhears 2 surgeons discussing contemporary techniques. He yells at them: barbarism!!! It’s barbaric. THAT IS THE STATE OF “MODERN” MEDICINE ON THIS PLANET TODAY. And the real crime is how the PR, marketing and advertising arms of the pharmo-medico industry has almost everybody brainwashed. THIS is the real crisis of health care today, not the cost, but the sham that passes for “healing”!

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    “THERE IS NOT A SINGLE DRUG ON THIS PLANET THAT IS GOOD FOR ANYTHING!!!! EVERY , E-V-E-R-Y!!!!! DRUG IS A POISON TO THE BODY!!!!!!! EVERY DRUG DAMAGES THE BODY. ALL ILLNESSES CAN BE CURED WITHOUT DRUGS. IN FACT, NO ILLNESS CAN BE CURED BY ANY DRUG!!!!”

    Randy Gomberg:
    Perhaps some research would be beneficial before making ignorant comments such as this. Im sure your tune would be different if you were lying in hospital dying of cancer. The idea that every drug is a poison to the body is at best amusing. In fact every common compound can be toxic, even water. The level of toxicity simply depends on dose. Drugs, when used properly, CAN cure disease and ARE beneficial to society. You also promote the benefits of natural medicines. Again i find this amusing as most natural medicine techniques that actually work rely on plant preperations. These are actually drugs, just in a leaf and not in a pill. This makes your comments just a little contradictary. Let me put a hypothetical to you. Your lying in hospital, with an infected cut on your leg. The doctor tells you he can cure it with “barbaric drugs” such as a simple antibiotic, or he can get kirk and bones off star trek to come and cure it for you; using “natural” techniques of old. Such as amputation. Which would you use?