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Kaiser Permanente Bans Prescription Painkiller Bextra Over Safety Concerns

Posted on: Monday, 31 January 2005, 21:00 CST

Jan. 29--Citing safety concerns over heart attacks and strokes, health care giant Kaiser Permanente will no longer prescribe Bextra -- a popular painkiller similar to the recently pulled-off-the-market Vioxx -- for its millions of patients.

The Oakland-based HMO, hospital and clinic network, which serves 6.2 million Californians and 8.5 million patients nationwide, has asked doctors to find safer alternatives for patients suffering from arthritis and other maladies. Kaiser pharmacies will stop filling prescriptions Tuesday and no longer issue refills starting March 1.

This is the first time Kaiser has banned a drug that is approved by the U.S. Food and Drug Administration, and a Kaiser spokesman said he believes no other health system has taken similar action against Bextra. Kaiser's use of Bextra is a tiny percentage of its overall prescriptions.

But the HMO's size and nationwide influence -- plus a recent New England Journal of Medicine admonition to doctors to stop prescribing Bextra "except in extraordinary circumstances" -- could prompt other large health systems to abandon the drug as well.

Kaiser said its moratorium on Bextra will continue for six months, or until the FDA or the drug's manufacturer, Pfizer Inc., can prove the drug is safe, according to a Kaiser press release.

"This is not a drug that saves lives," said Dr. Sharon Levine, a pediatrician who oversees medication usage for Kaiser Permanente's Northern California division. "It's a drug that provides a modest degree of pain relief -- no better than Motrin -- and the size of the risk, given the benefit provided, did not seem warranted."

Representatives from Pfizer could not be reached for comment Friday afternoon.

Bextra is one of the COX-2 inhibitors, a class of painkillers including Merck's Vioxx and Pfizer's Celebrex that has come under heavy fire since Merck pulled Vioxx off the market last year. On Friday, Merck announced that the federal Securities and Exchange Commission is making a formal inquiry into the company's handling of Vioxx, sending Merck stock tumbling.

Gentle on the stomach, COX-2 drugs are frequently prescribed for patients who cannot take ibuprofen or similar pain relievers because they are at high risk of developing ulcers. Levine said they are 10 times more expensive than older painkillers, many of which are available over the counter. The COX-2 drugs have been marketed heavily to consumers, but evidence is mounting that they increase the risk of heart attack and stroke -- and that they have been over-prescribed to patients who don't really need them.

Bextra earned Pfizer $1.29 billion in global sales for 2004, according to the New York Times. But Pfizer's Celebrex is its COX-2 blockbuster, generating $2.3 billion in sales in just the first nine months of 2004. In December, the company announced it would stop advertising Celebrex to consumers after a study showed high doses of it were associated with an increased heart attack risk.

A study published earlier this week in the Archives of Internal Medicine found that more than 70 percent of patients prescribed COX-2 inhibitors during their first three years on the market had a low to very low risk of developing ulcers or other gastrointestinal problems -- the very condition this class of drugs was created to prevent.

Concerns about Bextra's safety surfaced as early as 2002, when a small study of 462 coronary artery bypass patients found that those taking Bextra were twice as likely to experience heart problems.

A more recent 1,400-patient study showed that individuals taking Bextra were three times as likely to suffer heart problems. A Pfizer spokeswoman at the time said Bextra's heart side effects occurred in patients with a very high risk of heart disease. The study, first announced at a medical conference in November, was published this month in the journal Circulation.

Also in December, the FDA required a "black box" warning, its strongest, on Bextra packaging to inform patients about serious skin infection, heart attack, stroke and clot problems associated with the drug.

Levine said Kaiser has long been concerned about Bextra, Vioxx and other COX-2 drugs. Even before Vioxx was pulled off the market in late September, the health maintenance organization advised doctors to reconsider prescribing Vioxx to patients in favor of safer alternatives. Kaiser physicians prescribed COX-2 painkillers "100 times less" than non-steroidal anti-inflammatory drugs such as Motrin (ibuprofen) and Aleve (naproxen), Levine said.

The FDA, which has been criticized for its handling of COX-2 drugs, has ordered a review of dozens of clinical studies of their safety. The federal agency is expected to hold a public hearing in February examining the risks and benefits of these painkillers.

By Barbara Feder Ostrov and Esther Landhuis. Mercury News wire services also contributed to this report.

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PFE,

Source: San Jose Mercury News

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