Before Eileen Burden began taking the popular arthritis drug Vioxx, her joints ached so much she could barely get dressed in the morning.
A few months later, the 65-year-old Elk Grove Village woman felt good enough to take part in an AARP triathlon.
The drug she credits with helping her "get my life back" was abruptly pulled from pharmacy shelves Thursday by its maker, Merck & Co. Inc. Merck voluntarily yanked the blockbuster pain reliever off the market after a new study showed the prescription drug -- taken by about 2 million Americans for everything from arthritis to post- operative pain -- increased the risk of heart attacks and strokes after 18 months of use.
The news left Burden and many others in a quandary, wondering what to do now that Vioxx would no longer be an option.
"My phone hasn't stopped ringing all day," said Dr. Michael Ellman, a rheumatologist at University of Chicago Hospitals. Ellman and other physicians spent much of Thursday finding their patients alternative medications that their insurance would cover. "There are a lot of unhappy people because Vioxx seemed to work better for them than the other drugs."
When Vioxx and other medicines known as COX-2 inhibitors hit the market in 1999, they were hailed as "super aspirin" because of their ability to reduce inflammation and pain without causing irritating and potentially deadly stomach bleeding, a downside of traditional nonsteroidal anti-inflammatory drugs such as aspirin or ibuprofen.
It didn't take long for researchers to raise red flags about the potentially dangerous cardiovascular side effects of Vioxx, especially when taken at doses higher than 25 milligrams. Safety concerns prompted the Food and Drug Administration in 2001 to require that Merck add a new warning to the Vioxx label.
In August, an analysis of reports from patients and doctors found more heart attacks and strokes in those taking Vioxx or Celebrex, another COX-2 drug, than in those on conventional nonsteroidal anti- inflammatories.
The FDA said it will closely monitor all COX-2 drugs, but doctors said the risks appear to be greatest with Vioxx, the only such drug to be taken off the market so far. And those risks likely will go away quickly once the patient stops taking the drug, according to Dr. Alastair J.J. Wood, professor of medicine and pharmacology at Vanderbilt University Medical Center.
After hearing the news about Vioxx, staff at Midwest Heart Specialists searched the records of all of their patients.
"We're in the midst of calling 1,600 patients to tell them to stop taking the drug," said Dr. Vincent Bufalino, president of the suburban heart practice and medical director of Edward Heart Hospital in Naperville.
Rich Ringelstein of Naperville was particularly worried when he heard the news because he'd had heart bypass surgery a decade ago. He has been taking Vioxx for osteoarthritis.
"I went straight to my drug cabinet and threw it in the garbage," said Ringelstein, 62. "I'm going back to Celebrex."
Contributing: Sun-Times wires
Patients on Vioxx should talk to their doctors about possibly switching to one of these drugs.
*Other COX-2 inhibitors: Celebrex, Bextra.
*Prescription nonsteroidal anti-inflammatories, or NSAIDs: Clinoril, Orudis, Oruvail, Meloxicam.
*Over-the-counter NSAIDs: aspirin, ibuprofen (Motrin, Advil), naproxen (Aleve).
HOW TO GET A REFUND
Some pharmacies may give a refund for patients' unused Vioxx, or you can mail back the remaining pills in the original container along with a pharmacy receipt to:
2670 Executive Dr.
Indianapolis, Ind. 46241
Include a note with the patient's name, address and phone number. The company will reimburse the cost of the full prescription plus regular shipping. Get more information at www.vioxx.com or by calling (888) 368-4699.
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