In 2004, after years of controversy about safety considerations, pharmaceutical giant Merck finally pulled its
magnificent arthritis drug rofecoxib (Vioxx) from the market. The voluntary withdrawal came after a clinical trial
showed that participants taking it for more than 18 months were twice as likely to suffer a heart attack or
stroke than those taking a placebo.
VIOXX AND ITS COUSINS
Vioxx is a member of the nonsteroidal anti-inflammatory drug (NSAID) family that includes all over-the-counter
(OTC) pain relievers except acetaminophen (Tylenol). Vioxx belongs to a newer class of NSAIDs called COX-
2 inhibitors. Said to be less irritating to the stomach than standard NSAIDs, these drugs hit the market and
became instant best sellers. However, safety questions arose almost immediately, and it turns out that even
the most basic claims about COX-2 inhibitors and stomach protection may have been greatly overstated.
Vioxx users are angry that for five years Merck has been aware of -- but done little to warn the public about --
increased cardiovascular risk. Now the company is in hot water, with a billion-dollar class action lawsuit
against it already in the works. There also are accusations that the US Food and Drug Administration (FDA)
fell down on the job by failing to compel the pharmaceutical superpower to conduct appropriately rigorous
clinical studies. In The New England Journal of Medicine, two leading heart experts called for a
congressional investigation into the matter. (Stay tuned for more about the FDA and drug safety issues in an
upcoming issue.)
Until further research takes place to ensure their safety, scientists in the US and regulatory agencies in
Europe caution that two other COX-2 inhibitors, Celebrex and Bextra, also may be associated with a greater
risk for heart problems.
If you are taking a COX-2 inhibitor or any other NSAID...
Always be aware of a drug's possible side effects. Patients frequently fail to make the connection between
taking a new drug and a change in their physical state, which, in the case of NSAIDS, may be increased
blood pressure. Your doctor also may or may not be monitoring all of your symptoms for all of your health
issues, in which case the doctor, not realizing that the high blood pressure evolved in tandem with the
medication, may treat this new symptom with a second drug. Sometimes the new drug has yet another side
effect, and if the doctors involved do not make that connection, a third drug shows up in the patient's regimen.
According to Jay S. Cohen, MD, associate professor (voluntary) of family and preventive medicine at the
University of California in San Diego, this is called the "prescribing cascade," and older patients in particular
easily can become engulfed by it.
Talk to your doctor to see if there is anything about your health profile that might be cause for concern while
taking any NSAID -- in particular, liver problems.
Never take more than the recommended guidelines for any NSAID. Even Tylenol can lead to severe
consequences if misused. For more on the dangers of Tylenol, see Daily Health News, October 21, 2003.
Monitor your blood pressure weekly, and discuss any change with your doctor.
If you are currently taking Vioxx, contact your health-care provider to discuss discontinuing its use and to
explore possible alternative treatments. For example, OTC naproxen (as in Aleve) and ibuprofen (such as
Motrin and Advil) are effective and inexpensive and are not associated with increased heart attack risk.
If you think that you have suffered a severe adverse reaction to Vioxx, report it to the FDA at www.fda.
gov/medwatch. To learn more about the Vioxx situation, visit the FDA's drug information Web page at www.fda.
gov/cder.
Although it's not possible to cure arthritis, there are a number of ways to relieve it, he says. Anyone who is
overweight should trim the excess pounds -- being overweight adds pressure and subsequent discomfort to
joints.
Regular exercise also can ease arthritis aches. Keeping a proper posture and body alignment relieves
stress on the joints. Exercises that teach body alignment include the Alexander technique, Feldenkrais and
some types of yoga.
Or you can talk to your doctor about alternative remedies for arthritis, such as glucosamine, which recent
research found may halt or even reverse the progression of arthritis. (See Daily Health News, May 17, 2004.)
Most important -- be safe... be informed... be well.
The FDA approved Vioxx in 1999. It was intended to reduce the pain and inflammation caused by
osteoarthritis as well as menstrual pains. Afterwards, the FDA approved Vioxx for the treatment of rheumatoid
arthritis. The drug, which is a once-daily pill, was considered more effective than traditional pain killers and to
cause fewer gastrointestinal side effects.
What is Vioxx?
Vioxx is a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID). Vioxx is also related to the
nonselective NSAIDs , such as ibuprofen and naproxen. Vioxx is a prescription medicine used to relieve
signs and symptoms of arthritis, acute pain in adults, and painful menstrual cycles.
Minor side effects with the use of Vioxx include upset stomach, dizziness, heartburn, vomiting and
constipation. In March, 2002 an FDA report linked Vioxx to five cases of a nonbacterial type of meningitis. In
May 2002, a report published in the Journal of Bone and Mineral Research stated that it may also impede
bone repair due to the arthritis drug inhibiting cox-2 (which assists bone-forming cells in the healing
process.)
The makers of Vioxx launched a three year study to confirm the relative gastrointestinal benefits of Vioxx when
compared to another pain medicine, naproxen. The study did show that patients who took Vioxx had fewer
ulcers and other stomach ailments, but the shock of the study proved to be the greater tendency to
experience serious cardiovascular events when taking Vioxx.
In September 2004, Merck & Co., Inc., announced a voluntary withdrawal of Vioxx from the market due to
safety concerns of an increased risk of cardiovascular problems such as heart attack, stroke, and blood clot.
The study found that both high and low levels of the medication increase the risk, but patients taking the
highest doses increase their risk of heart attack more than three-fold.
In Vioxx and naproxen test groups with more than 4,000 patients in each, Vioxx users suffered 101 “serious
cardiovascular events” and 20 myocardial infarctions. That compared to 46 naproxen users who had
cardiovascular events and only four who suffered heart attacks.
If you have concerns about the safety of Vioxx, or if you have experienced serious side effects associated with
the drug, consult your doctor. It may also be important to contact an attorney who can help protect your legal
rights. Please keep in mind that there may be time limits within which you must commence suit.
