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An interview with a Mayo Clinic Specialist
By Mayo
Clinic staff excerpt taken from www.mayoclinic.com
 The
arthritis drug rofecoxib (Vioxx) was withdrawn from the market
after a study demonstrated that it increases the risk of heart
attack and stroke. Vioxx, a COX-2 inhibitor, is a nonsteroidal
anti-inflammatory drug (NSAID) used to manage pain and inflammation.
The drug is sold in some countries under the name Ceoxx.
Millions of people around the world relied on Vioxx for pain
relief. So if you're confused about what to do next, you're not
alone. Should you stop taking Vioxx right now? Are other COX-2
inhibitors safe? Eric Matteson, M.D., a rheumatologist at Mayo
Clinic, Rochester, Minn., discusses common concerns about Vioxx
and related drugs.
Why was Vioxx pulled off the market?
The immediate withdrawal of the drug was based on data from a
three-year trial designed to evaluate the possible effectiveness
of Vioxx in preventing the recurrence of colon polyps. In comparing
people taking Vioxx versus those taking a placebo, the study reported
an increased relative risk of cardiovascular problems, such as
heart attack and stroke, after 18 months of Vioxx. According to
the Food & Drug Administration, although your risk of having
a heart attack or stroke related to Vioxx is very small compared
to people not taking Vioxx, the degree of risk depends on how much
Vioxx they have taken, and for how long.
What is the risk associated with Vioxx?
Your risk overall is low. Studies show your risk of heart attack
and stroke can be as low as a couple of percentage points higher
to as much as three times higher than the risk faced by those who
haven't taken Vioxx. The risk appears to be greater for those who
take very high doses of Vioxx — 50 milligrams (mg). Most
people take 12.5-mg or 25-mg doses.
No one knows exactly what the risks are for lower doses because
Vioxx was never studied specifically for its effect on heart attack
and stroke. Some people may have had heart attacks or strokes because
of Vioxx, but doctors didn't realize that was the cause. Unfortunately
heart attacks and stroke are very common in general, so doctors
weren't looking for a connection to Vioxx.
Who is at risk of having a heart attack or stroke because of
Vioxx?
The study that caused Vioxx to be withdrawn from the market found
that people taking the drug for 18 months or longer had the increased
risk of heart attack and stroke. However, other studies reviewing
shorter clinical trials and normal prescription use also found
evidence of an increased risk. It's possible that heart attacks
and strokes can be caused by Vioxx when taken for a shorter amount
of time.
How long does it take for Vioxx to leave your body? Are there
any side effects of stopping medication?
Vioxx clears out of your body in four to five days. You might
notice an increase in pain and inflammation — the reasons
you started taking the drug. When you stop taking the drug, you
can expect these to become worse. Vioxx is not addictive, so you
shouldn't notice any symptoms of withdrawal.
If you stop taking Vioxx, will your risk of heart attack and
stroke continue?
Nobody knows for sure.
Should you stop taking Vioxx right now, or should you wait to
see your doctor?
Contact your doctor promptly to discuss alternatives. Don't panic.
Most people have taken Vioxx for some time and haven't had problems,
and may choose to take it for a short while, until they can to
get a satisfactory alternative. But it is important to contact
your doctor as soon as possible. Most people can speak to their
doctor over the phone to discuss other options. Try to make the
switch to a new drug as soon as you can.
What are the alternatives to Vioxx? Do they have side effects?
Several alternatives to Vioxx exist, including the two other
COX-2 inhibitors — celecoxib (Celebrex) and valdecoxib (Bextra).
COX-2 inhibitors are usually reserved for people who can't take
traditional nonsteroidal anti-inflammatory drugs (NSAIDs) because
of a history of stomach bleeding or ulcers.
People taking warfarin (Coumadin), older adults, and people taking
drugs that contain prednisone should consider taking COX-2 inhibitors
other than Vioxx because they have an increased risk of stomach
bleeding.
COX-2 inhibitors aren't usually necessary for an otherwise healthy
person who, for instance, has a sprained ankle. That person should
take other forms of pain relievers. And if you have sulfa allergies,
you shouldn't take celecoxib or valdecoxib because those medications
can cause allergic reactions.
If you aren't at risk of stomach bleeding, your first choice
should be traditional NSAIDs such as ibuprofen (Advil, Motrin,
others) and naproxen (Aleve, Anaprox, Naprelan, Naprosyn). Traditional
NSAIDs are just as effective as COX-2 inhibitors for reducing pain
and inflammation.
If you switch from Vioxx to a traditional NSAID, be aware that
some can cause stomach bleeding in a small percentage of people.
If you're concerned about stomach bleeding, consider taking an
NSAID along with a proton pump inhibitor, which protects your stomach.
All NSAIDs, including the selective COX-2 inhibitors like celecoxib
and valdecoxib, can cause kidney problems, hypertension and fluid
retention.
- COX-2
inhibitors
- Nonsteroidal
anti-inflammatory drugs (NSAIDs)
- NSAIDs:
How to avoid side effects
For people with pain who don't need an anti-inflammatory, you
could try over-the-counter or prescription pain relievers such
as acetaminophen (Tylenol, others) tramadol (Ultram), and non-aspirin
salsalate products (Disalcid, Trilisate, others).
Do other COX-2 inhibitors carry the same risk of heart attack
and stroke as Vioxx?
Currently available evidence suggests they don't carry the same
risk. But they may cause an increased risk that we don't fully
know about yet, and doctors are highly concerned about this possibility.
These drugs haven't been studied specifically for heart attack
and stroke risk. If you're concerned about a potential risk of
heart attack and stroke, talk to your doctor.
What if Vioxx was the only medication that worked for you? What
do you do then?
You may need to consider combining other drugs to get the relief
you need. Also consider nondrug alternatives, such as heat and
cold, physical therapy and massage to help with your pain and inflammation.
Massage:
A relaxing way to relieve muscle tension
If you're willing to take the risk, can you continue taking Vioxx?
For some people, this drug is very helpful and it's very difficult
to give it up. But Vioxx is no longer available, so this isn't
an option.
Will Vioxx likely come back on the market, but with a stronger
label warning?
It isn't likely that Vioxx will be available again. When considering
a medication, you need to weigh the benefits versus the risk of side
effects. There are drugs available that may work just as well for
you as Vioxx did and offer fewer side effects.
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