-Caveat Lector-
Patients fill Vioxx vacancy Like millions of arthritis sufferers, she was a long-time
user of Vioxx, the popular painkiller that was pulled from the market two weeks
ago because of an increased risk of heart attack and stroke.
On her doctor's recommendation, Frey, 57, switched in
February from Vioxx to Bextra, another in a family of anti-inflammatory drugs
that also includes Celebrex.
Now she wonders if Bextra is safe.
� Lipobay/Baycol,
distributed by Bayer, muscle discomfort linked to at
least 40 deaths worldwide. The drug represented a 2
percent share of Bayer's total revenue. The company's
stock dropped 20 percent in one month after the
medication was pulled from shelves in August 2001.
� Prempro,
manufactured by Wyeth, connected to cancer, strokes and
heart attacks. The medication was halted from
distribution in July 2002, resulting in a 15 percent
stock drop. It had represented 15 percent of Wyeth's
sales.
� Vioxx,
manufactured by Merck, garnered 11 percent of the
company's total revenue. Within two days of the
September announcement it was being pulled, Merck's
stock took a 26 percent drop.
For refunds, Merck and Co., the
manufacturer, is asking users to mail back the unused
drug in the original container, along with a pharmacy
receipt, to: NNC Group, Merck Returns, 2670 Executive
Drive, Indianapolis, IN 46241.
A note with the patient's name,
address and phone number should be included. The company
will reimburse the cost of the full prescription plus
regular shipping.
More instructions and information
are available on the Internet at www.vioxx.com
and www.merck.com or by calling (888) 368-4699.
Doctors are being asked to send back
samples, and pharmacists will be contacted by Merck
representatives on returning unsold inventory. Frey decided not to take any kind of Cox-2 inhibitor after
the Vioxx announcement on Sept. 30 by the manufacturer, Merck & Co.
"But every bone in my body hurt. So I went back on it
yesterday, a half dose," she said of Bextra. "It's a question of pain or this:
health concerns."
The Food and Drug Administration approved Vioxx in 1999 to
help reduce pain and inflammation caused by osteoarthritis. A current long-term
Vioxx study by Merck into the drug's colon cancer-prevention qualities
backfired, revealing what past studies also showed -- an increased risk of heart
attack or stroke. The FDA in 2002 required that Vioxx labels listed that
information.
Dr. Michael Fulton, a Daytona Beach orthopedist, said he
doesn't recommend the long-term use of any of the Cox-2 inhibitors, prescribing
them usually for no more than 10 days.
"We work more with exercise intervention," he said. "We use
them as an aid to get back to exercising."
Dr. Howard Offenberg, an Ormond Beach rheumatologist, said
he was not a fan of Vioxx, given the medical concerns that arose from past
studies.
"We just didn't know why, and it's still unclear," he said.
"But this news was not new. It was not a major surprise."
Offenberg said only about 3 percent of his patients were
taking Vioxx, usually arthritis sufferers who had been placed on the drug by
another doctor and were doing well.
He said studies of Celebrex and Bextra, which differed from
Vioxx in how they were conducted, did not reveal any heart risk.
"It's probably unlikely they'll be taken off the market," he
said.
But until the FDA does a controlled study of all Cox-2
inhibitors, Offenberg said the question remains "if it's a one-drug problem or a
class problem."
For that reason, the doctor said he prefers prescribing a
variety of effective generic drugs for most of his arthritis patients. Those
drugs might be harder on the stomach, but he said they are easier on the
pocketbook, costing up to three times less than Vioxx.
Randy Margrave, a clinical pharmacist at Holly Hill
Pharmacy, has a different take on the safety of Vioxx and other Cox-2
inhibitors.
He said the earlier drugs of choice for many arthritis
sufferers, which included aspirin and ibuprofen, benefited the heart, thinning
the blood. Vioxx didn't.
"It's not because of the drug," he said of heart problems
being attributed to Vioxx. "It's because of the protection they got from
aspirin. If people took a baby aspirin with Vioxx, the studies would never have
been skewed."
Meanwhile, 53-year-old Cheryl Gurley, a registered nurse
from Flagler Beach, is feeling the pain.
"I want my Vioxx back and I want it now," she said,
laughing.
Bextra and Advil don't provide the same relief for the
arthritis in her hands, neck and lower back. And while older people might be at
risk, she says her heart wasn't damaged by Vioxx.
"It was a really good medicine for me," Gurley said. "I
still have 10 left. I'm so tempted."
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