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Recall Rattles Patients ; Vioxx Heart Risk Should Vanish By Discontinuing Use of Drug, Local Physician Says.

Posted on: Tuesday, 19 October 2004, 15:00 CDT

Some arthritis sufferers who appreciated the anti-inflammatory medicine Vioxx for its power over pain are now worried that the medicine might have hurt their heart.

They've been phoning their physicians for advice in the wake of the announcement by Merck & Co. that it has pulled Vioxx off the market because it increases the risk of cardiovascular disease.

Dr. Brent Mohr, a rheumatologist at the South Bend Clinic, said it will take a while for him and his staff to help patients make the transition to a different pain reliever.

"Over the next couple days, we'll be doing a lot of scrambling to answer everybody's questions," Mohr said. "We're telling them to stop taking the drug and find an alternative."

Officials of Merck announced the voluntary recall on Thursday, saying that one of its own studies had shown that Vioxx increases a person's risk for heart attack and stroke after 18 months of use.

The trial was intended to determine whether the nonsteroidal anti- inflammatory, which has become a best seller since its introduction in 1999, prevented the recurrence of colorectal polyps and might therefore be useful against cancer.

But the 2,600 patients in the study also were monitored for cardiovascular problems, such as heart attack and stroke. Previous studies had suggested Vioxx increased the risk for such events.

Mohr said Vioxx was welcomed as one of a new and improved kind of nonsteroidal anti-inflammatory medicine -- the class of drugs called COX-2 inhibitors -- when it came out five years ago.

The COX-2 inhibitors, which also include Celebrex and Bextra, have been shown to cause less stomach and intestinal bleeding during long-term use than older anti-inflammatory drugs, such as ibuprofen and naproxen.

Such gastrointestinal bleeding was a major, and deadly, risk for people with rheumatoid arthritis or osteoarthritis who must take pain relievers every day, he said.

But now, one of the drugs that reduced that risk has been shown to increase the risk for heart attack and stroke. Some patients who have called his office have been very upset at the news, Mohr said.

"The reaction has been 'Oh, my gosh, what have I done to myself?' " he said. "There's a bit of panic."

Mohr said his staff has been reassuring patients that the increase in cardiovascular risk appears to end once patients stop taking Vioxx. Moreover, it takes only two or three days for the medicine to be cleared from a person's system.

"The risk seems to exist only when they're taking it," he said. "When they stop, it goes away."

Mohr said none of his patients have had heart attacks or strokes while taking Vioxx. Some, however, have had to go off Vioxx because of swollen ankles or increased blood pressure, two side effects that are considered to be cardiovascular.

He and his staff have been suggesting immediate alternatives to Vioxx for their patients so that they won't have to go without pain relief. In some cases, he said, he's prescribing them other drugs, based on a review of their medical records and their promise to come in within a few weeks for an exam.

Among the alternatives are the two other COX-2 inhibitors, which also can cause the cardiovascular side effects of fluid retention and affecting blood pressure.

All the traditional nonsteroidal anti-inflammatory drugs are still available as well. The risk of stomach bleeding can be reduced by taking a drug like Prilosec, which inhibits stomach acid production. But then the patient has replaced one drug with two, a step backward, Mohr said.

Staff writer David Rumbach:

drumbach@sbtinfo.com

(574) 235-6358

Source: South Bend Tribune

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