By CHRIS DATOL

With the recent pullout of the COX-2 painkiller Bextra (generic name valdecoxib) by the Bureau of Food and Drugs (BFAD), Pfizer, Inc. insisted it will still work on having their product, along with its injectable prodrug Dynastat (parecoxib) re-introduced to the market in the near future, "considering the benefits that these products offer to patients."

The US Food and Drug Administration (FDA) has ordered Pfizer, Inc., to suspend sales of the drug in the United States, Canada and Europe last April 7, citing potential risks of cardiovascular problems and "life-threatening skin reactions."

An advisory from BFAD Director Leticia Barbara Guttierez meanwhile imposed the pullout in the local market last April 12, noting that Bextra and Dynastat posed a risk of rare but life-threatening skin reactions like Erythema Multiformae, Stevens Johnson’s Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).

Pfizer earlier attempted to defer the suspension of the drug in the Philippines, saying it "disagrees with FDA’s position regarding the overall risk/benefit profile of valdecoxib."

The company emphasized it agreed to withdraw the drug even though its cardiovascular risk "could not be differentiated" from that of other painkillers.

Pfizer’s Medical Director Dr. Anthony Leachon explained that the local dosage of Bextra for arthritis, pain and other acute conditions is more acceptable and does not pose serious risks as the high-dosage prescription for chronic illnesses in the US and Europe which led to the pullout.

"We were caught by surprise with the BFAD’s decision because they pointed out the rare skin reactions as the cause of the suspension. But as we explained to them, these reactions are already described in Bextra’s label, and are known to be caused by other drugs as well," he said.

"Doctors right now are at a loss because they have found these medications to be reliable options for the treatment of pain. We intend to explore ways with BFAD under which this could be made possible," Dr. Leachon added.

Pfizer reported sales of $1.3 billion for Bextra last year.

Bextra is the second painkiller to be withdrawn from the market after Merck’s Vioxx, which was voluntarily pulled out by its drugmaker in September last year. The COX-2 drugs, including Pfizer’s Celebrex, are widely prescribed for arthritis and severe pain but have all come under fire recently for being linked to a higher incidence of cardiac problems in some patients.

Celebrex however remains in the market after the FDA reaffirmed the use of celecoxib capsules for the treatment of pain and inflammation of rheumatoid arthritis and osteoarthritis.

After a meeting with Dr. Leachon and experts from medical associations in the country last April 11, BFAD decided to abide by the FDA decision and ordered the pullout of Bextra from the local market effective April 12.

Meanwhile, a day after the FDA announced its ruling (April 7), BFAD’s counterparts in Asian countries like Singapore and Malaysia already called for Bextra’s withdrawal in their respective markets.

US health officials have also ordered new warning labels for a similar class of drugs, including Pfizer’s Celebrex.

Both the FDA and BFAD have asked all pharmaceutical companies to: Have black boxed warnings regarding heart problems and stomach bleedings on all prescription NSAIDs; revise product labels for all OTC NSAIDs, except aspirin; give additional information side effects; and to develop labels/posters for OTC NSAIDs warning the public about potential adverse skin reactions.

"For now, patients should stop taking Bextra and contact their physicians about appropriate treatment options," Pfizer said.