Vioxx, Celebrex May Up Risk of Kidney Failure, Heart Attack

[Guest guest]

Safety of Arthritis Drugs in Question:

Vioxx, Celebrex May Up Risk of Kidney Failure, Heart Attack

http://my.webmd.com/content/article/1728.83308

July 10, 2001 (Washington) -- A woman who developed kidney failure after

taking the popular arthritis drug Vioxx has raised more questions about

the safety of this and similar drugs.

Vioxx belongs to a class of drugs known as COX-2 inhibitors. When they

first emerged in the late 1990's, COX-2 inhibitors were touted as being

safer and more effective than readily available nonsteroidal

anti-inflammatory drugs, or NSAIDs, such as aspirin and ibuprofen.

But in recent months, the cardiovascular safety of Vioxx and Celebrex,

another COX-2 inhibitor, has been questioned; and a report published in

a recent issue of The Lancet suggests this group of drugs also can harm

the kidneys.

In a June issue of the medical journal, L. Roche, MD, and

Fernandez-Alonso, MD, of the Hospital Universitario Virgen del Rocio in

Spain, describe the case of a 67-year-old woman who developed a type of

kidney failure. The condition seems to have been due to Vioxx because

once the woman stopped taking the drug, she recovered.

Though it is known that NSAIDs can cause kidney failure, this case is

the first to show that COX-2 inhibitors may be associated with the

condition, Roche and Fernandez-Alonso report in The Lancet.

At the same time, both Merck, the manufacturer of Vioxx, has received

reports of several cases of possible kidney failure associated with

their drug, and Pharmacia, the manufacturer of Celebrex, has received 11

similar reports in people taking their drug. However, none of the

reported conditions were conclusively diagnosed as kidney failure.

The suggested association between kidney failure and COX-2 inhibitors is

not surprising, Larry Sasich, PharmD, MPH, of the consumer advocacy

organization Public Citizen, tells WebMD. Kidney problems " are a side

effect of all NSAIDs, " including COX-2 inhibitors, he says. He notes

that the current labels for Celebrex and Vioxx carry the same warnings

and risks as other NSAIDs, including the potential kidney damage.

Vioxx and Celebrex " are no more effective than other NSAIDs, and there

appears to be no safety advantage, " Sasich says. Arthritis patients

would be better off financially and medically taking a cheaper NSAID,

such as ibuprofen, which are a fraction of the price of the COX-2

inhibitors, Sasich adds.

Kidney failure is not the only concern, though. In February, the FDA and

its arthritis drugs advisory committee reviewed whether COX-2 inhibitors

increased the risk of heart attacks. That question was raised following

a study Merck presented to support its contention that Vioxx is safer on

the gastrointestinal tract than other NSAIDs.

The study found that Vioxx cut the occurrence of ulcers and other

gastrointestinal problems by half compared with the over-the-counter

NSAID Aleve. But the study also showed that people taking Vioxx had four

times the risk of a heart attack.

So, should people taking Vioxx also take aspirin to reduce their risk of

a heart attack? Not an easy question to answer since aspirin can

increase the risk of gastrointestinal problems. However, Merck has

reviewed all their Vioxx studies and found no evidence that the drug

increases the risk of a heart attack compared with other NSAIDs, company

spokeswoman Fanelle tells WebMD. The company contends that

Vioxx's effect on the heart is negligible and that it only appeared to

increase the risk of a heart attack because Aleve, like aspirin,

actually reduces heart attack risk.

But some patients at risk for a heart attack may already be taking

aspirin to protect their hearts, and Merck has a trial underway now to

determine if using Vioxx and aspirin together will increase the risk of

gastrointestinal problems. The results should be out next year, Fanelle

says.

Other data gave the FDA reason to be concerned about the potential for

Celebrex to cause heart problems. A study published in the Journal of

the American Medical Association last year found that Celebrex was

associated with an increased risk of heart attack and other heart

problems.

At a February FDA meeting, Nissen, MD, a cardiologist at the

Cleveland Clinic Foundation and an adviser to the FDA, said in reference

to Celebrex, " The question is, are we giving these agents to patients at

higher cardiovascular risk, and if we do so, will we see something that

we wished we didn't see, and I don't know the answer to that. "

Whether the FDA will change the label of Vioxx or Celebrex to highlight

the potential for heart problems remains uncertain. Neither the FDA nor

Pharmacia returned phone calls from WebMD.