2008-11-12

Pain Drugs Double Risk of Second Heart Attack, Death in Study

By Nicole Ostrow

Nov. 11 (Bloomberg) -- Heart attack and heart failure patients have a higher risk of a second heart attack or death if they take painkillers including the generic drug ibuprofen and Pfizer Inc.'s Celebrex, a Danish study found.

The risk doubled within the first 90 days on the painkillers Celebrex or Merck & Co.'s withdrawn Vioxx in those who had survived a heart attack or heart failure, compared with those who didn't take the medications, according to research presented today at the American Heart Association meeting in New Orleans. Other common painkillers, such as the generics diclofenac and ibuprofen, increased the risk between 2.1 and 1.3 times.

About 8.1 million people in the U.S. have had a heart attack and 5.3 million Americans suffer from heart failure, according to the Heart Association Web site. Based on today's findings, doctors should avoid prescribing painkillers called NSAIDS, or nonsteroidal anti-inflammatory drugs, for these patients, or give them at the lowest dose for the shortest time, researcher Gunnar Gislason said.

``The take-home message is that we need to be careful when using NSAIDs among patients with previous heart attack or heart failure, and we need to carefully consider the balance between risk and benefit when considering starting NSAID treatment in high-risk patients,'' said Gislason, a senior resident in cardiology at Copenhagen University Hospital in Denmark, in an e-mail. ``Even short-time treatment with NSAIDs seems to increase cardiovascular risk among these patients.''

Painkiller Popularity

The researchers analyzed the records of 58,432 patients who had a previous heart attack and 107,092 with heart failure in Denmark. Of those, 36 percent of the heart attack patients and 34 percent of the heart failure patients said they took at least one painkiller after they were discharged from the hospital.

Patients who had suffered a heart attack and were taking the painkiller Vioxx had 2.7 times the risk of having another heart attack or dying compared with patients not taking painkillers. Heart attack patients taking Celebrex had double the risk, while those with heart failure taking Celebrex had 2.3 times the risk. Heart attack patients taking diclofenac had 1.9 times the risk, while those taking ibuprofen had 1.3 times the risk, according to the study.

Pfizer spokeswoman Shreya Jani said the company couldn't comment without seeing the study.

``We do know there will be an increased risk of dying from a heart attack in the first year after the event, regardless of NSAID use,'' she said. ``Since 2005, all prescription NSAIDs, including Celebrex, naproxen, ibuprofen, diclofenac and Mobic amongst others, have boxed warnings that provide important information about possible impact of these medicines on the cardiovascular systems. Patients and doctors should discuss this and other information about medicine and the patient's health and decide what is right for each patient.''

Celebrex Risks

A study presented in March at the American College of Cardiology meeting in Chicago found that patients taking the highest dose of Celebrex at 400 milligrams twice a day tripled their chance of a heart attack or stroke compared with people taking a placebo. Those taking Celebrex twice daily at the 200- milligram dose doubled their risk of a heart attack. People with heart disease, high cholesterol, diabetes or who smoked also had an increased risk, the researchers said.

A more definitive assessment of Celebrex risks won't come until 2013, when a $100 million study of 20,000 patients comparing Celebrex with the pain pills ibuprofen and naproxen is expected to be completed. Jani said the safety monitoring committee met recently and noted that the study could continue unchanged.

Celebrex had $2.3 billion in 2007 sales for New York-based Pfizer.

To contact the reporter on this story: Nicole Ostrow in New York at nostrow1@bloomberg.net.

Last Updated: November 11, 2008 10:54 EST

Source : Bloomberg

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