Pharmaceuticals —Vioxx Recall
On September 30, 2004, Merck & Co., Inc. announced a recall of Vioxx, an arthritis and acute pain medication. The recall was Merck’s response to clinical trials demonstrating an increased risk for heart attack and stroke beginning after 18 months of Vioxx treatment.
NEW YORK (Reuters) – Merck & Co. (MRK.N: Quote, Profile, Research) said on Thursday it would be withdrawing its arthritis drug Vioxx globally after a colon cancer trial confirmed long-standing concerns that the drug raises the risk of heart attack and stroke.
Merck’s shares plunged in pre-market trading after the announcement. A recent study by the U.S. Food and Drug Administration suggested patients taking Vioxx faced a 50 percent greater risk of heart attacks and sudden cardiac death than those taking Pfizer Inc.’s (PFE.N: Quote, Profile, Research) rival Celebrex treatment.
Vioxx had sales last year of $2.55 billion. They have been flat in recent years amid ongoing safety concerns.
Merck said it is withdrawing the drug following data from a new three-year trial of Vioxx, designed to evaluate the effectiveness of the drug’s standard 25 milligram dose in preventing recurrence of colorectal polyps. Such polyps often become cancerous.
“In this study, there was an increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment in the patients taking Vioxx compared to those taking placebo,” Merck said in a release.
“It’s a major blow for Merck,” said Sena Lund, an analyst at Cathay Financial. “It was one of their five key drivers for future growth.”
Merck had expected Vioxx to help restore the company’s earnings growth when the drug was launched in 1999, but its sales have been hurt by clinical trial data showing it increased the incidence of blood clots tied to strokes and heart attacks.
Meanwhile, sales of Pfizer Inc.’s similar drugs, Celebrex and Bextra, have steadily grown as doctors have turned to those drugs, which have not been linked to heart attack and stroke.
Damage Caused By Vioxx
Vioxx (manufactured by the pharmaceutical giant Merck) is a member of a new category of drugs released onto the market in the late 1990’s. These new drugs were known as “Cox Inhibitors.” They are related to a class of drugs called Non-steriodal Anti-inflammatory Drugs (NSAID’s for short). We all know, and have used, these NSAID’s under their more common names such as ibuprofen and naproxen.
Although related to traditional NSAID’s, Cox inhibitors operate inside the body in a different fashion. NSAID’s provide pain relief and anti-inflammatory effects by blocking the body’s production of both Cox-1 and Cox-2 isoenzymes. The problem with NSAID’s arises out of their inhibition of the production of Cox-1. Cox-1 provides protection to the gastrointestinal system. Thus, when production of Cox-1 is eliminated, serious gastrointestinal problems can occur.
Vioxx, however, operates to selectively inhibit the production of the Cox-2 isoenzyme while leaving unaffected the body’s production of Cox-1. Cox-2 normally is produced at sites of inflammation within the body. Thus, Vioxx has been designed to target and inhibit the production solely of Cox-2. The theoretical benefit of selective Cox-2 inhibition is that it reduces inflammation and accompanying pain, while eliminating the gastrointestinal problems associated with traditional NSAID’s.
Unfortunately, research has indisputably proven that selective Cox-2 inhibition throws off the body’s normal balance. When this homeostatic balance is disrupted a chemical imbalance occurs that results in the development of blood clots. These blood clots form within the vascular system and tend to develop in the coronary arteries or the arteries of the brain. When this occurs heart attacks and strokes usually result.
Recent studies have shown that Vioxx can increase the incidence of heart attack nearly four times greater than that of traditional arthritis pain relievers like NSAIDS. More specifically, the new study out of the Cleveland Clinic noted an increase in the development of myocardial infarctions, or heart attacks, in people treated with Vioxx, when compared with those treated with naproxen (a standard NSAID).
Whether the increased risk of heart attack is attributable to a property of Cox-2 inhibitors (this includes both Vioxx and Celebrex), or whether it is solely specific to Vioxx, is not yet known.
If you or a loved one have been injured by Vioxx and are considering a Vioxx lawsuit, you may be entitled to compensation.
For more information, please contact Stephen A. Corr, Esq. at
scorr@mellonwebster.com.
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