FRIDAY, Oct. 1, 2004 (HealthDayNews) -- A day after one of the largest drug recalls in history, America's 2 million Vioxx users are left wondering what's next in terms of relieving their arthritis pain.
Fortunately, a wide range of safe, effective treatment alternatives are waiting on drugstore shelves, experts say.
"There are several anti-inflammatory medicines that have the same effect as Vioxx, and several in the same class of cox 2 inhibitors," said Dr. Michael Fleming, president of the American Academy of Family Physicians.
Dr. Alice K. Jacobs, president of the American Heart Association, added that patients making a move from Vioxx to another treatment should consult with their doctor first, however.
"Only your doctor can evaluate your individual risk and recommend the best course of treatment, including alternative options for arthritis," she said in a statement.
On Thursday, New Jersey-based Merck & Co. announced it was voluntarily removing Vioxx from markets worldwide after its own research found long-term users faced increased risks for heart attack and stroke.
The three-year study, involving 2,600 patients taking either a placebo or 25 milligrams of Vioxx daily, found that cardiovascular risks to Vioxx users began to rise 18 months after they started on the drug.
Overall, 3.7 percent of patients using Vioxx for at least 18 months experienced at least one type of serious cardiovascular event during the study period, compared to only 1.9 percent of those on a placebo. Based on this increased risk, Merck halted the trial of a medication that had brought in $2.5 billion in sales last year alone.
Until its removal, Vioxx was one of three drugs from the cox 2 inhibitor family of compounds -- which also includes Bextra and Celebrex -- approved for use in the United States to fight osteoarthritis-related pain and inflammation.
It is also part of the larger family of non-steroidal anti-inflammatory drugs (NSAIDs). These pain-relieving compounds include over-the-counter medications such as aspirin, ibuprofen (Advil, Motrin, Nuprin) or naproxen (Aleve).
In a U.S. Food and Drug Administration press conference held Thursday, Dr. Steven Galson, acting director of the agency's Center for Drug Evaluation and Research, stressed that the other compounds appear to be safe.
"The other [NSAIDs], including the cox-specific and non-cox-specific drugs, do not have this same incidence of heart attack and stroke in clinical trials," he said. "There is a real difference in the data."
That's good news for arthritis sufferers looking for alternatives to Vioxx, said Dr. Daniel Solomon, a professor of medicine at Harvard Medical School and a rheumatologist at Brigham and Women's Hospital in Boston.
"For example, they can take Motrin -- it's every bit as effective as Vioxx at reducing pain and inflammation," he said. "Also naproxen (Aleve) is very effective, and there are 10 other drugs in the same category, the NSAIDs, that are very effective."
However, a minority of patients cannot take NSAIDs because of an increased risk for gastrointestinal complications associated with these drugs. Solomon said "those patients could be directed to Celebrex," another cox 2 inhibitor. Cox 2 inhibitors such as Celebrex and Bextra fight inflammation without affecting the digestive tract.
Alternatively, he said, NSAID-sensitive patients could take an NSAID plus a pill to help prevent gastrointestinal symptoms. "Something like Motrin plus Prilosec," Solomon suggested. "That's as good as Vioxx."
He stressed that patients who have used Vioxx over the long term shouldn't be overly alarmed at the safety data released yesterday.
"First of all, we don't know whether patients are going to have long-term carry-over side effect," he said, "but the assumption is that once the drug is out of your body, the potential side effect should go away, as well."
Just to be sure, however, Galson said the FDA, in cooperation with Merck, will continue to track the cardiovascular health of the participants who were in the halted trial, to see if changes -- for good or bad -- occur as time goes on, long after they stop using Vioxx.
Galson said patients would be wrong to assume that risks seen with Vioxx hold true for other cox 2 inhibitors. "You just can't extrapolate from one drug to another, even in the same class," he said. "We know from hard experience that you just can't do that."
Solomon agreed, citing the example of Baycol, one of a family of cholesterol-lowering statin medications that was recently withdrawn from the market. Baycol "had a high risk of liver failure," he pointed out, "but we still have six other statins on the market that are much safer."
Following the withdrawal of Vioxx, health experts are urging patients to consult first with their doctors, and not be unduly alarmed. Expensive tests to check for cardiovascular function are probably not warranted, Solomon said, even in patients with a long history of Vioxx use.
"I think that, other than checking your blood pressure and having a general examination by a physician, there's nothing specific I would suggest," Solomon said. "I certainly don't think anyone would suggest having an electrocardiogram or a stress test."
More information
For more on the Vioxx recall, visit the U.S. Food and Drug Administration.
