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Should I Stop Taking Vioxx?

By Dr. Peter W. Kujtan, B.Sc., M.D., Ph.D.

This is an edited version of the original article printed on page 13 in the October 9-10, 2004 issue of
The Mississauga News under the Feature: Health & Wellness, Doctor's Corner

The answer is a resounding yes. Stop taking the Vioxx medication and talk to your doctor soon. There are no side-effects associated with a sudden stop of Vioxx use. As of this printing, I have been informed that unused Vioxx can be returned to your pharmacy for a refund. Call 1-800-567-2594 for more information.

Vioxx is the brand name for an anti-inflammatory medication called rofecoxib. It is a relatively new medication launched in 1999 as another therapy for arthritis. Its primary mode of action is to inhibit an enzyme called COX-2. This group of medications was initially touted as a potent anti-inflammatory painkiller better than the traditional NSAIDS (non-steroidal anti-inflammatories) such as Naproxyn, Anaprox, Ibuprofen, Aspirin and Voltaren. The NSAIDs inhibited both COX-1 and COX-2. Cox-1 is an enzyme which helps maintain the stomach lining, while COX-2 is a potent cause of inflammation. The most attractive thing in the initial marketing was the illusion that the COX-2 inhibitors could not cause gastrointestinal bleeding because they did not affect COX-1. They were much more expensive than the older medications and huge profits were at stake for any manufacturer who could get into the game. Other COX-2 inhibitors are Celebrex, Bextra and Mobicox. There are no recall notices for any of these yet.

It soon became evident that even though this group of medications did cause less stomach upset and hyperacidity, patients started having the occasional bleeding and gastritis with prolonged use. The incidence was much less than with NSAIDS, but was far from zero. The notion that Vioxx might be implicated in heart attacks first appeared in 2000, but the evidence was sketchy.

A large study was commissioned by the makers of Vioxx, Merck Sharp & Dome in 2001. They were looking for new uses. One of the corridor hypotheses suggested that COX-2 inhibitors might be useful in preventing colon cancer. APPROVe stands for the Adenomatous Polyp Prevention on Vioxx Trial. It was a three-year trial involving 2600 patients designed to see if Vioxx could prevent the recurrence of neoplastic polyps in the large bowels of people with a history of colorectal adenoma. The trial was stopped when participants taking Vioxx for more than 18 months developed a significant increase in their risk to develop a stroke, heart attack or blood clot. It is important to remember that we are dealing with probabilities. We all have a certain risk value to develop these conditions. I calculate it for many patients after their physicals by factoring together blood pressures, lab values, and certain other parameters to come up with a statistical number. It is largely unknown if simply stopping the drug will decrease the risks, since it took 18 months of regular use to raise them. Those patients who did not use the drug for 18 continuos months have less to be concerned about. There is good reason to be suspicious that all COX-2 inhibitors may increase cardiovascular risks. I suppose you could take aspirin with your COX-2, and so lower your risk profile, but that would be re-inventing the wheel.

On the one hand, I was happy to see that ethics prevailed and Merck Frosst decided to end the trial, withdraw the drug and make a statement as to why without releasing specific data. This is far more than the non-licensed makers do. They adopt the opposite stance, and simply assume product safety and efficacy by a few testimonial accounts. When someone else spends the time and money to prove them wrong, they just remove the product and conjure up a new one in its place. I mention this only because you can be sure there will be a surge of advertising hype devoted to "safe alternatives". Consumers beware, because it is not the case at all, and I would not recommend products which haven't undergone vigorous and publishable scientific trials.

On the other hand, there is a bothersome element to this whole scenario. Prescription drugs such as Vioxx have been appearing in American media ads beamed directly at the public. The ads never mentioned the increase in cardiovascular risk. This marketing bypasses the need to convince doctors about a new drug. Instead it creates prescribing pressure when patients demand what they see on television. That same element is now injected into physician marketing. At one time, Merck was a proud provider of non-biased non-product medical education for doctors. The pendulum has now swung to the point that physicians are doggedly pursued as "invited guests" to "educational lectures". Most of these educational events are drug commercials where hired gun lecturers extol the virtues of new drugs or expanded roles for expensive existing drugs, using data often derived from studies sponsored by the manufacturer themselves. In the last four years, known cardiovascular issues related to Vioxx were only mentioned if directly asked by the armies of representatives camped in doctors' waiting rooms. The hot industry issue is "Who pays for the sandwich?" when it should be "Who pays for the side-effects?" Perhaps it is time to re-examine at how drug information is disseminated in the whole industry, and that includes the non-regulated lucrative herbs and supplement market!

Related resources:

Important Drug Safety Information on VIOXX® - Merck Frosst Canada Inc. from Health Canada.
Merck Announces Voluntary Worldwide Withdrawal of VIOXX® from Merck.
Vioxx (rofecoxib).
GENERIC NAME: rofecoxib, BRAND NAME: Vioxx from MedicineNet.
Merck yanks arthritis drug Vioxx - News sent stock down nearly 27 percent and erased $25 billion from its market value - from CNNMoney, Oct. 6, 2004.
Vioxx Information from Drugs.com.
Vioxx FYI - Vioxx info & litigation.

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