If nothing else, the removal of the painkiller Vioxx from the market
last week served as a reminder that new drugs sometimes turn out to have
unforeseen side effects after a few years of widespread use, and it makes
sense to use them with caution.
"When we weigh the risks and benefits of medication, the word 'new' has
to be added to the risk side," said Dr. Susan Louisa Montauk, of the
University of Cincinnati College of Medicine. "That does not mean that one
should never use a new drug, but it does make it a risk, because major
concerns can come up as long as eight to 10 years down the line."
But in the wake of Vioxx's withdrawal, many patients and doctors are
trying to decide what to do next. Merck's drug, an anti-inflammatory
belonging to the class called cox-2 inhibitors, was used by more than 2
million people for, among other things, arthritis, pain and the possible
prevention of colon cancer.
Now patients are wondering if they should turn to another prescription
cox-2 inhibitor, like Celebrex or Bextra, or an over-the-counter
anti-inflammatory like ibuprofen (marketed as Motrin or Advil) or naproxen
(marketed as Aleve).
Dr. Jerry Avorn, the author of "Power Medicines: The Benefits, Risks
and Costs of Prescription Drugs," said he thought that when older drugs
were available, "there better be a damn good reason to take the new
drug."
He recommended that patients ask their doctors, "Does this drug have
any important advantage over existing drugs that would make it worth my
taking it?"
When it comes to the remaining cox-2 inhibitors, doctors cannot yet
answer the question: Studies are still trying to sort out whether the
problems with Vioxx � increased risk of heart attack and stroke � are
shared by all drugs in the class.
So far, there is no evidence that Celebrex or Bextra poses a similar
risk. Two recent studies indicate that the cardiovascular risks of
Celebrex are not as great as those of Vioxx. But long-term trials have yet
to be completed. And there have been no studies of cardiovascular risk in
patients taking Bextra. (The Food and Drug Administration has said it will
monitor the two drugs.)
Merck stopped selling Vioxx last week after a long-term study, financed
by the company, showed that people taking the drug had more cases of heart
attack, stroke or blood clot (15 per 1,000 people per year) than people
taking a placebo (7.5 per 1,000 people per year).
Vioxx, Celebrex and Bextra are all relatively new. The FDA approved
Vioxx in 1999, Celebrex in 1998 and Bextra in 2001. Several other cox-2
inhibitors are in the pipeline. The drugs, which block an enzyme called
cyclooxygenase, or cox, are not thought to be more effective than the
over-the-counter painkillers. But unlike older painkillers, they block cox
selectively, leaving intact a form that helps protect the stomach lining,
and are believed to be less irritating to the stomach and are therefore
useful for people with peptic ulcer disease and other digestive-tract
problems.
But doctors say that people with intestinal sensitivities are not the
only ones taking the drugs. Aggressive marketing by drug companies has led
to overprescribing, said Avorn, who is also a professor of medicine at
Harvard.
The withdrawal of Vioxx from the market, he said, "may be an
opportunity for people who are on horribly expensive medications that they
didn't need to be on to get onto something cheaper, which will help their
pocketbooks as well as their arthritis."
One drawback of the over-the-counter medications is that, unlike Vioxx,
which patients typically took once a day, drugs like ibuprofen must be
taken three times a day. "Three times a day is a lot more than three times
more difficult than once a day for many people," Montauk said.
Some experts have recommended that patients on Vioxx stop taking it
abruptly. But Montaux cautions against changing drugs before talking to a
doctor, even if it takes a few weeks to get an appointment, because the
risk of Vioxx is not serious enough to warrant panic.
"I do think it's important for people to not stop abruptly," Montauk
said. "An abrupt increase in pain could also put a strain on the
cardiovascular system."
Patients with arthritis and stomach problems who have been taking Vioxx
may want to switch to a different type of prescription anti-inflammatory
medication that is somewhat gentler on the stomach than ibuprofen or
naproxen, for example, nabumetone (marketed as Relafen) or etodolac
(marketed as Lodine), said Dr. David Campen, a rheumatologist at Kaiser
Permanente in Oakland, Calif.
These drugs can be combined with Prilosec, a prescription medication
used to treat acid reflux disease, to protect against stomach irritation,
Campen said.
In mild cases of arthritis pain, patients might also try nondrug
remedies, like exercise and stretching. There is some evidence that the
dietary supplement glucosamine can ease some types of joint pain.
Some people have been treated with Vioxx to prevent cancerous colon
polyps. Theoretically, the drug can fight the inflammation that causes
polyps. (The Merck study that led to the drug's withdrawal was testing its
effectiveness against colon polyps.)
Dr. Sudhir Diwan, director of pain medicine at New York-Presbyterian
Hospital, said he would probably switch some patients who were taking
Vioxx for colon polyps to other cox-2 drugs.
But Campen said any anti-inflammatory medication would work against
colon polyps � even small daily doses of aspirin taken to prevent heart
disease.
Dr. Jim C. Martin, a physician in San Antonio, said he had received
calls from many patients wondering what to do next. He said, "I am going
to recommend that except for those with gastrointestinal problems that we
go back and look seriously at some of the older and more used
anti-inflammatories like ibuprofen and
naproxen."
