Millions of Americans who were prescribed Vioxx or Celebrex in the drugs' first few years on the market could have safely taken older, cheaper painkillers such as ibuprofen, a new study says.
The drugs' main selling point was that, theoretically at least, they were less likely to cause bleeding and other serious stomach complications than older nonsteroidal anti-inflammatory drugs, or NSAIDs.
But patients at low risk for such problems accounted for two-thirds of the growth in Vioxx and Celebrex use from 1999 — when the drugs came on the market — to 2002, researchers report today in the Archives of Internal Medicine.
Recently raised concerns about the effects of Vioxx, Celebrex and other so-called COX-2 inhibitors on the cardiovascular system magnify the problem of prescribing such drugs to patients at low risk for stomach problems, says co-author Randall Stafford, a Stanford University internist.
Stafford and his co-authors analyzed data from government surveys about outpatient visits to doctors and hospitals. In 1999, Vioxx and Celebrex prescriptions represented only about a third of all those written for NSAIDs at outpatient visits, the researchers found. The older NSAIDs accounted for the rest.
By 2001, though, the situation had practically reversed. Nearly two-thirds of NSAID prescriptions were for Vioxx or Celebrex, and little more than one-third were for the older NSAIDs.
That might have happened in part because doctors and patients tend to equate "newer" with "better," Stafford says. "There's an assumption that newly approved drugs somehow have proven themselves to be better than what's already available." In reality, Stafford points out, they have been proved only to be better than a placebo.
Stafford and his co-authors add that marketing efforts also contributed to Vioxx's and Celebrex's blockbuster status. In 2000, they note, Merck spent $161 million on direct-to-consumer ads for Vioxx, more than that spent on any other drug that year.
Merck, which makes Vioxx, pulled it from the market Sept. 30 after a company-sponsored study found more heart attacks and strokes in patients who took the drug than in those given a placebo. When Vioxx was withdrawn, 2 million in the USA were taking it, the Food and Drug Administration says.
Since then, studies comparing Celebrex and Bextra, a newer COX-2 inhibitor, to a placebo have shown that they also could increase heart attack and stroke risk, especially if taken for long periods or by people at high risk for such problems. They remain on the market, although Pfizer, maker of both, has stopped direct-to-consumer marketing of Celebrex. An FDA advisory panel will meet next month to discuss the safety of COX-2 inhibitors.
Source: http://www.usatoday.com/news/health/2005-01-23-vioxx-usat_x.htm
The drugs' main selling point was that, theoretically at least, they were less likely to cause bleeding and other serious stomach complications than older nonsteroidal anti-inflammatory drugs, or NSAIDs.
But patients at low risk for such problems accounted for two-thirds of the growth in Vioxx and Celebrex use from 1999 — when the drugs came on the market — to 2002, researchers report today in the Archives of Internal Medicine.
Recently raised concerns about the effects of Vioxx, Celebrex and other so-called COX-2 inhibitors on the cardiovascular system magnify the problem of prescribing such drugs to patients at low risk for stomach problems, says co-author Randall Stafford, a Stanford University internist.
Stafford and his co-authors analyzed data from government surveys about outpatient visits to doctors and hospitals. In 1999, Vioxx and Celebrex prescriptions represented only about a third of all those written for NSAIDs at outpatient visits, the researchers found. The older NSAIDs accounted for the rest.
By 2001, though, the situation had practically reversed. Nearly two-thirds of NSAID prescriptions were for Vioxx or Celebrex, and little more than one-third were for the older NSAIDs.
That might have happened in part because doctors and patients tend to equate "newer" with "better," Stafford says. "There's an assumption that newly approved drugs somehow have proven themselves to be better than what's already available." In reality, Stafford points out, they have been proved only to be better than a placebo.
Stafford and his co-authors add that marketing efforts also contributed to Vioxx's and Celebrex's blockbuster status. In 2000, they note, Merck spent $161 million on direct-to-consumer ads for Vioxx, more than that spent on any other drug that year.
Merck, which makes Vioxx, pulled it from the market Sept. 30 after a company-sponsored study found more heart attacks and strokes in patients who took the drug than in those given a placebo. When Vioxx was withdrawn, 2 million in the USA were taking it, the Food and Drug Administration says.
Since then, studies comparing Celebrex and Bextra, a newer COX-2 inhibitor, to a placebo have shown that they also could increase heart attack and stroke risk, especially if taken for long periods or by people at high risk for such problems. They remain on the market, although Pfizer, maker of both, has stopped direct-to-consumer marketing of Celebrex. An FDA advisory panel will meet next month to discuss the safety of COX-2 inhibitors.
Source: http://www.usatoday.com/news/health/2005-01-23-vioxx-usat_x.htm