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Drugs encapsulate risk, relief: No easy advice to swallow

By LYNN FRANEY

The Kansas City Star - Dec. 24, 2004 - How safe are the anti-inflammatory drugs many of us depend on for relieving our aches and pains? Should we keep taking Celebrex and Aleve, even though a similar drug — Vioxx — was pulled from the market recently and federal health officials now say Celebrex and Aleve also might increase the chance of a heart attack or a stroke? People across the Kansas City area these days are asking themselves and their doctors these troubling questions.

Unfortunately, there are no easy answers. Medications are complicated, and each person has a unique medical history that makes it either safe or less safe to take these types of drugs. The Food and Drug Administration on Thursday ordered reviews of ongoing patient studies of the prescription painkillers Celebrex and Bextra in light of recent findings that they may increase the risk of heart attack and stroke. It also issued an advisory urging the public to limit the use of over-the-counter anti-inflammatory pain medications such as naproxen, ibuprofen and aspirin to 10 days without a doctor's approval.

But most of us, medical experts say, probably can keep popping the occasional Celebrex or Motrin for headaches or menstrual cramps without worrying too much that the painkiller might be slowly killing us. Of course, that's only if we don't take too many of them too often, and we don't have a family history of heart disease or other risk factors.

“It's really quite a quandary right now,” said Dan Stechschulte, a rheumatologist at the University of Kansas Hospital. “I don't think physicians have enough information for each patient to make a decision. I'm a little more careful taking a family history of risk factors for patients over 50. I wish it was clearer for all of us, but it's not.”

Doctors who work frequently with these drugs, however, say that the average younger person should not panic over newspaper headlines or the potential cardiovascular risks. “There are valid concerns,” said Matthew Nadler, a physician with the Headache and Pain Center in Johnson County. Still, Nadler said that information in the news media about these drugs “has frightened a lot of people who really don't need to be that concerned.” Refraining from smoking, losing weight and exercising also have a major impact on cardiovascular health, Nadler pointed out. “The very common-sense issues out there regarding heart disease are probably much more significant than intermittent use of the non-steroidal anti-inflammatory drugs,” he said.

Karen Norris, a pharmacy professor at the University of Missouri-Kansas City who serves as assistant director of the university's Drug Information Center, said she understands how all the attention paid to anti-inflammatories can be confusing for the average person. “We're all in a little over our head on these issues,” Norris said. The most common questions people are asking, she said, are: “Should we stop taking these drugs? Should we really be worried?” The answers, she acknowledged, aren't clear. “So far we've said, ‘We don't have enough data.' We have not been recommending that people stop taking their drugs. What we've been doing is trying to get patients plugged back in with their physician,” Norris said.

“But what seems to be emerging is a pattern,” she continued. “It looks like, potentially, for patients with pre-existing cardiovascular problems or pre-existing congestive heart failure, there may be something going on there. There's enough smoke to see if there's a fire.” Here are answers from experts to some commonly asked questions about medications that reduce pain and inflammation, known as non-steroidal anti-inflammatory drugs:

Q: What is the difference between the new, prescription-only anti-inflammatory drugs — Vioxx, Celebrex, and Bextra, (COX-2 inhibitors) — and older, over-the-counter anti-inflammatories, such as Aleve and Advil?

A: The COX-2 drugs target an enzyme that contributes to inflammation. The older anti-inflammatories interfered more than the newer drugs with a related enzyme that protects the lining of the stomach. So the COX-2 drugs are thought to lessen the stomach bleeding and gastrointestinal problems experienced by people taking the older anti-inflammatories. Thus, patients have been able to take these drugs over a period of years for serious, chronic conditions such as rheumatoid arthritis.

Q: Why was Vioxx pulled off the market in late September?

A: Several studies — most recently one on whether Vioxx could prevent the recurrence of polyps in colon cancer patients — revealed that participants were more likely to suffer heart attacks and strokes after taking the drug for a long time.

Q: Why is the federal government now cautioning people about using Celebrex and Aleve?

A: Long-term studies of whether everyday use of these drugs could help protect people from diseases such as cancer and Alzheimer's disease showed an increased risk of heart attacks or strokes in study participants.

Q: What are the general guidelines for safely taking a pain-killing, anti-inflammatory?

A: Take them only when needed and with the advice of your physician. Only take the amount prescribed or recommended on the label. Only take them for as many days as recommended under the prescription or label.

Q: How serious is the risk of developing cardiovascular problems from taking these anti-inflammatory drugs?

A: “The actual risk is small,” Nadler said. “It may be present, but for the majority of the people, it is small.” The study that showed problems with Celebrex, for example, focused on elderly people who were given large doses of Celebrex to see if it helped prevent Alzheimer's. Thus, the risk for heart disease among the study population may be much larger than that among younger people taking much smaller doses.

Q: What should people do if they regularly take Celebrex and Aleve?

A: The first thing they should do is talk to their doctor to see whether they should continue taking the drugs and whether they might be eligible for alternatives.

“There's no question that potent COX-2 inhibitors at high dosages, long-term, are dangerous,” said KU's Stechschulte. “Use as low a dose as you can and, if you have to use high doses, be aware that you are probably increasing your risk of cardiovascular problems. Over-the-counter drugs such as Aleve were an alternative to COX-2 inhibitors, until the latest study threw that drug's safety into doubt. Doctors must assume that other similar over-the-counter pain relievers, such as ibuprofen, pose the same risk. “They all inhibit COX-2,” Stechschulte explained.

An alternative may be taking a baby aspirin (81 mg.) along with COX-2 inhibitor pills, because the aspirin's heart-protective effects may counter some of the harm from the other pills. And for some people, COX-2 inhibitors may be safe, Stechschulte said. But in the future doctors will need better tools, such as genetic tests, to identify which patients are more at risk using the drugs. Until then, there is always what Stechschulte calls the “grin and bear it approach” to aches and pains — returning to good old-fashioned liniments and ice packs.

The Star's Alan Bavley contributed to this report.

To reach Lynn Franey, call

(816) 234-4927 or send e-mail to lfraney@kcstar.com.

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