Pulling Bextra Unlikely to Spark a Drug Scramble

When the popular painkiller Vioxx was taken off the market last fall, confusion ruled as doctors and patients scrambled for alternatives.

The withdrawal of Bextra on Thursday prompted far less turmoil.

Since the demise of Vioxx, many doctors had been moving away from the entire class of pain drugs known as Cox-2 inhibitors. Once lauded as wonder drugs, they had fallen short of their promise, doctors realized.

The same benefits could be achieved for most patients by using other drugs, they said, reflecting a growing sentiment that Cox-2 inhibitors, which have been linked to heart attacks and strokes, had been overprescribed for years.

“Older drugs will provide similar levels of pain relief and stomach protection ... but without the same level of concern regarding cardiac problems,” said Dr. A. Mark Fendrick, an internist at the University of Michigan.

Still, the removal of Bextra jolted some patients, particularly those who have had to switch drugs several times in the past.

One of them, 61-year-old Linda Clark of Encino, has suffered from pain for 18 years and has tried nearly every pain medication. On Thursday, she chose to use Celebrex, now the last Cox-2 inhibitor on the market and the drug most similar to her old favorite, Bextra.

“It is the only one that gave me any pain relief,” she said.

Some doctors were also concerned that the FDA had gone overboard in removing Bextra, stripping away an important pain-fighting option.

Dr. Joshua Prager, a pain expert at UCLA, said the crippling power of pain had been neglected in the debate. He now has to find a replacement for Bextra for hundreds of patients.

But for some doctors and patients, the removal of Bextra was a possibility they had already considered because of the extensive debate over the safety of Cox-2 inhibitors.

The debate began in earnest last fall when Merck & Co. voluntarily stopped selling its blockbuster painkiller Vioxx after studies showed it nearly tripled the risk of heart attacks.

The debate has led to a reassessment of how freely these painkillers have been prescribed.

Cox-2 inhibitors, doctors say, were too often prescribed to people who could have been treated with older and less expensive medicines.

The drugs were designed to provide relief while lowering the risk of stomach bleeding -- a common side effect of traditional pain medicine. But most people getting the drugs were not especially susceptible to bleeding, said Dr. Garret Fitzgerald, chairman of the pharmacology department at the University of Pennsylvania.

Doctors are questioning whether Cox-2 inhibitors really provide more protection from stomach bleeding than some of the earlier painkillers.

Prescriptions have fallen off sharply. Kaiser Permanente, a large healthcare provider, had phased out its use of Bextra. The group still prescribes Celebrex -- but cautiously and rarely.

“If it works for [patients], then we will use it,” said Dr. Gerald Levy, chief of rheumatology at Kaiser Permanente’s Bellflower Medical Center. “But it sure isn’t the first-line drug.”

Celebrex will now be required to carry the government’s strongest warning, a “black box” label alerting doctors and patients of cardiovascular risks.

A National Cancer Institute study found that in high doses -- four times that typically used for pain -- Celebrex more than tripled the risk of a heart attack or stroke.

There are many alternatives, but those requiring a prescription will carry the warning.

For patients not prone to stomach bleeding, there are several nonsteroidal anti-inflammatories (NSAIDs) available, including the over-the-counter medications Aleve and Motrin.

Patients with stomach issues can take the same drugs in combination with stomach buffering agents known as proton pump inhibitors, which include Prilosec, Prevacid and Nexium.

Other pain-fighting options include Tylenol, aspirin and, in some cases, opiate-containing drugs, such as Vicodin.