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TRENTON, N.J. -- For years, Americans have been popping painkillers like they were candy to treat everything from headaches to arthritis, but new data show America's love affair with the medications may have cooled off after the blockbuster drug Vioxx was pulled from the market over safety concerns.
New data show sales of prescription arthritis drugs plunged at the end of 2004, after Merck & Co. Inc. of Whitehouse Station, N.J., pulled Vioxx from the market Sept. 30, and a string of recent studies raised safety concerns about other widely used pain medicines.
Nonprescription pain reliever sales jumped by double digits in late 2004, but doctors and other pain experts believe many patients are simply suffering in silence, confused about what pain medication is best for them.
"I've been in practice for 30 years and I've never seen such a mess," said Dr. Michel Dubois, director of the New York University Pain Management Center.
He estimates about 20 percent of his patients have switched from Cox-2 inhibitors, the painkiller class including Vioxx and Pfizer Inc.'s Celebrex and Bextra, to narcotic painkillers or nonprescription ones. Another 20 percent have stopped taking painkillers altogether.
Advisers to the Food and Drug Administration are scheduled to meet for three days starting Wednesday to try to find a balance between the benefits and potential dangers of Cox-2 drugs. FDA eventually is likely to require strong warnings on the drugs' labels, further dampening Cox-2 sales, predicted independent pharmaceuticals analyst Hemant Shah of HKS & Co. in Warren, N.J.
Meanwhile, data released Monday by IMS Health of Plymouth Meeting, Pa., show prescriptions filled for Cox-2 inhibitors -- preferred by many patients and doctors because they cause fewer stomach and intestinal problems than older anti-inflammatory drugs -- had fallen 43 percent in December 2004 from a year earlier.
IMS, a pharmaceutical information and consulting company, said the number of Cox-2 prescriptions filled at retail and mail-order pharmacies and nursing homes, about 70 percent of U.S. sales, dropped from 4.5 million in September to 2.7 million in December.
Vioxx patients switch drugs
Lisa Morris, global marketing director at IMS, said about two-thirds of Vioxx patients switched to other Cox-2 drugs, and the other third switched to other nonsteroidal anti-inflammatory drugs if they stayed on prescription medicines.
"Whenever there is press around drug safety, you will see that people will sit it out for a while trying to figure out what to do," Morris said.
Total patients taking Cox-2 drugs or any nonsteroidal anti-inflammatory drugs dropped 9 percent from September until December 2004, she noted.
"It is disconcerting because it could mean there are people due to the confusion who are doing nothing and experiencing pain," said William Rowe, executive director of the American Pain Foundation, which recommends people consult with their doctor about other pain treatments.
"There are alternatives, complementary alternatives to pain relief, things like massage and baths and acupuncture and hot and cold (packs) which are documented to provide relief," Rowe said.
Carolyn Nuth, 62, of Baltimore, who has arthritis and fibromyalgia, went off Vioxx in October and has since found other prescription and over-the-counter pain relievers don't help her as much, so she uses hot and cold packs more.
"I'm a little depressed, and I feel very limited physically," said Nuth, who works at the pain foundation answering consumers' questions. She said the public seems as confused as she is, and inquiries about treatment options jumped about 15 percent after the Vioxx withdrawal.
In the week after Merck pulled Vioxx from the market worldwide because its own study had showed Vioxx increased risk of heart attacks and strokes after long-term use, Celebrex and Bextra picked up most of its share of the prescription painkiller market, according to data from Impact Rx, a Mount Laurel, N.J., company that tracks doctors' prescribing patterns.
Safety of Cox-2s questioned
That week, there was about a 25 percent jump in the number of patients being switched to a different prescription painkiller or starting on one for the first time.
However, by the beginning of February, amid reports questioning the safety of all Cox-2s, the share of pain patients starting on or switching to Celebrex and Bextra was down from a total of about 25 percent to a combined 8 percent, according to Impact Rx. The two drugs' share was taken over by other prescription nonsteroidal anti-inflammatory drugs, including Mobic and different brands of prescription strength ibuprofen.
Naproxen, sold in prescription strength as well as over the counter under brands including Aleve, had seen a one-third jump in new prescriptions following the Vioxx withdrawal. That reversed right after the federal government on Dec. 21 halted an ongoing Alzheimer's disease prevention trial because researchers documented more heart attacks and strokes among patients taking naproxen.
"Recent events in this category have clearly affected physician prescribing behavior," said Nancy Lurker, chief executive of ImpactRx. "The dramatic shift back to the older, more established drugs and away from the Cox-2s is largely unprecedented in a market this size."
Part of that trend is for patients to revert to over-the-counter drugs.
Sales of nonprescription pain pills jumped about 12 percent from the July-September quarter to the October-December quarter, according to marketing information company ACNielsen, which did not have a breakdown by brand.
Shah, the analyst, said it probably will take five to seven years before drug companies can restore sales of nonsteroidal anti-inflammatory drugs, given "gun shy" consumers and expectations that FDA will require significant long-term safety data before it approves any new painkillers.
For patients in pain, that could be a very long wait."I'm hoping maybe something else comes out" soon, Nuth said.
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