Weighing Drug Risks And Benefits

Recent caution flags about popular medications such as Vioxx, Celebrex and naproxen, the main ingredient in Aleve, have raised consumer concern about overall drug safety. All have been used for years, but new studies have linked them to possible increased risk of heart disease and stroke.

So just how safe are the drugs in your medicine chest?

Dr. Richard Stein, a cardiologist and spokesman for the American Heart Association, cautions that patients shouldn't always be quick to turn their backs on drugs called into question.

Stein explained to The Early Show co-anchor Hannah Storm that initial clinical trials of drugs are designed to check whether they're safe and effective for their intended uses.

"For Aleve," Stein says, "we knew it was safe to take it for short periods of time as a pain reliever and anti-inflammatory. What's happening now is that we're doing all these studies to see if certain drugs can benefit other conditions. It's the next generation of drug trials. In the case of Aleve, they were looking to see if it would have any affect on the progression of Alzheimer's disease."

That raises questions "across the board," he adds. "For example, hormone replacement therapy was being used for 30 years before we found out that it can be bad for women."

But, "I'd hate to see a witch hunt for all these drugs," Stein asserts. "We don't want to make people go back to using Tylenol and cold packs for conditions like arthritis. Take each patient on a case-by-case basis.

"If you have a patient with a high risk for heart disease, you might not want to prescribe Aleve. But at the same time, if that patient can't even get out of a chair without using Aleve, you have to measure the risks and benefits. If that person's life is going to be sedentary and miserable if they don't take Aleve -- even with a higher risk for heart disease -- I might still recommend taking Aleve. For a number of my patients, increasing their risk of a heart attack is not as bad as making them chair bound."

Stein says we could, "Think about it this way: We take a risk every time we take a pill. One of the major causes of kidney failure is abuse of Tylenol. Any drug that is overused increases the percentage of risk for something."

He feels the Food and Drug Administration should require drug companies to run these studies: "If there's evidence that these drugs will be used for longer periods and higher doses than the clinical trials, I think there should definitely be mandatory studies," Stein says. "But I don't think that if a problem is found, (it) should automatically trigger a recall like with Vioxx. Vioxx is a good drug that helped a lot of people. What should have happened is that it should have been labeled accordingly: 'If you have a high risk for heart attack, don't take Vioxx.' I think appropriate warning labels are a much better option."

On another note, Stein stresses that the first thing we should be asking ourselves and our doctors is, "Do I really need that drug?"

"Perhaps an exercise regimen of swimming or stretching might work just as well, or even better, to alleviate pain than the drug you were taking," he points out.

"But the bottom line," Stein continues, "is that I think we're looking at a class of drugs that have really been helpful. To totally deprive patients of them would do more harm than good."