Vioxx Pulled

Most people don't worry about their prescription medication being recalled but it happens. On September 30, 2004, Merck and Co. recalled their arthritis and acute pain medication Vioxx (rofecoxib, also called Ceoxx) because studies showed an increased risk of cardiovascular events when this medication was taken for more than 18 months.

Vioxx, a COX-2 inhibitor drug, was developed in Montreal and introduced to the market in 1999. Before the recall Vioxx was distributed in more than 80 countries and represented one of the company's top five drugs, with worldwide sales in 2003 exceeding $2.5 billion and Canadian sales totalling $194.5 million. In Canada alone, 3.3 million prescriptions for Vioxx were filled. After the recall, Merck stocks dropped 28 percent.

The APPROVe Study

The decision to recall Vioxx was made following results of the APPROVe (Adenomatous Polyp Prevention on Vioxx) study. This trial was designed to determine the effectiveness of the drug in preventing the recurrence of colon cancer. For 156 weeks, 1,287 people took 25 milligrams of Vioxx, while 1,299 people took placebo.

After 18 months, 45 people (3.5 percent) taking the drug and 25 people (1.9 percent) taking placebo experienced heart attacks or other cardiovascular problems. Merck immediately halted the study.

Heart Risks Long Known

Earlier studies had questioned the safety of Vioxx. All of them found that taking the drug was associated with an increased risk of heart complications.

In August 2004, the US Food and Drug Administration sponsored a study showing that people taking 15.5 mg of Vioxx had a 50-percent greater chance of heart attack and sudden cardiac death than those taking the COX-2 inhibitor, Celebrex, which is made by Pfizer their competitor. They also discovered that taking the highest recommended dose (50 mg) of Vioxx increased patient risk of heart attack and sudden cardiac death by three times.

Asking the Right Questions

The recall of Vioxx has raised an important question: Are the governing health authorities prematurely approving new drugs without sufficient study data?

Jillian Clare Cohen, a drug industry analyst and professor of pharmacy at the University of Toronto, told CBC Health and Science News, "I think the FDA should've been out there demanding more data from the company [after]."

Dr. Jim Wright, head of the Therapeutics Initiative at the University of British Columbia, adds, "Where they can anticipate that there will be widespread use, they should mandate a longer term trial, and make it conditional on the continued licensing of the drugs."

As of October 2004, Health Canada will not be making any changes to its drug approving procedures, nor will it monitor drugs after they are released. It will, however, look into other Vioxx-like drugs for signs of increasing heart attack risk.

Merck's Future

Merck is now working on Vytorin, a combination of Merck's Zocor (to reduce risk of heart attack) and Merck/Schering-Plough Pharmaceuticals' Zetia (to reduce bad cholesterol). This new combination drug could reach sales of $2.5 billion in 2008 according to Stephen M. Scala, an analyst from SG Cowen, the securities and investment banking service. But can we be assured that Vytorin will be safe?

Is There an Alternative?

Natural alternatives to prescription drugs for arthritic pain are available and have been proven effective. Taking these instead of COX-2 inhibitors can reduce the worry of heart attack (see sidebar). Always do your research and talk to your health care provider before taking any new medication.