Eleven patients using Vioxx have died in Britain according to a UK drug regulatory body, but the drug manufacturer Merck & Co. deny its arthritis drug was linked to the mortalities.
In addition to the deaths the UK’s regulatory bodies, the Medicines Control Agency and the Committee on the Safety of Medicines has received 1,120 reports of adverse effects to rofecoxib, the generic name for Vioxx.
According to the report published in the agency’s September newsletter Current Problems, “Gastrointestinal (GI) adverse reactions account for almost half (554) of the reports, of which the majority were nausea, dyspepsia, diarrhea and abdominal pain. However, there have been 68 reports of upper GI perforations, ulcerations and bleeds (PUBs). Forty-four of the patients with PUBs recovered, although five had a fatal outcome.”
It is these five fatalities, along with six other deaths in people with possible cardiac failure and among people with a high risk factor for cardiovascular disease, that has raised the alarm for prescribers and consumers alike.
The other deaths mentioned in the report were part of a total of 192 incidences of suspected cardiovascular reactions, including 15 reports of cardiac failure, 101 reports of edema and 19 reports of palpitations.
Merck & Co., the US drug giant, said that none of the deaths was linked to the medicine. A spokeswoman for the company, Mary Elizabeth Basaman said “There is not a cause and effect. They’re not attributing anything to a specific drug.” Another Merck official, Eve Slater, added, “The report…is no cause for concern.”
The drug maker also pointed out that eleven deaths in a large aging population should not be considered remarkable.
However, the regulatory agency’s report concluded with a cautious note. “As with all new drugs, the safety of refocoxib remains under close review.”
An estimated 557,100 prescriptions for Vioxx were dispensed in Britain up to the end of May 2000. The rate of reported adverse reactions is approximately one per 500 prescriptions.
Vioxx is approved in the US and UK as a treatment for osteoarthritis, the most common form of arthritis affecting more than 16 million Americans. Its competitor is another drug also in the same class of non steroidal anti-inflammatory drugs, the Cox-2 inhibitor Celebrex, manufactured by Pharmacia Corp. Last year, Celebrex reached $1.5 billion in sales and Vioxx, launched four months later, garnered $472 million. Both drugs are considered safer and easier to handle than some older arthritis medications such as aspirin.
Rofecoxib (Vioxx) does come with warnings that it is contraindicated in patients with active peptic ulceration or GI bleeding, as well as for patients with severe congestive heart failure. Caution is also urged for users who have a history of cardiac failure, left ventricular dysfunction or hypertension, and in patients with pre-existing edema for any other reason.