Studies often do not show rare or long-term effects that may become evident after a drug hits the market and many thousands of people are taking it. The FDA needs to do a better job of monitoring side effects at that point.

By the beginning of this year, a consensus had developed on the link between COX-2 drugs and heart disease risk: The evidence for cardiovascular side effects was strongest for Vioxx and Bextra, intermediate for Celebrex, and weak for naproxen.

An overview article in the March issue of the Harvard Health Letter explains this consensus and can serve as a base of information that readers can turn to as this story continues to unfold.

Risk-Benefits Analysis Important

There's no such thing as a medication free of side effects, the article points out. Every drug carries some risks.

Also, the balance of benefits and risks of any treatment differs from person to person.

For instance, COX-2 inhibitors were showing promise in reducing the development of precancerous polyps and their growth into colon cancer. The Harvard Health Letter says that some people would certainly accept an increased risk of heart disease as the price for lowering colon cancer risk.

Role of Advertising, Regulation

The article also discusses the role of marketing, pointing out that it changes the equation. When drugs are marketed heavily to patients and doctors, there's a powerful tendency to prescribe the newest options -- even though older and less expensive drugs often are just as effective.

Monitoring side effects post-approval is important, experts agree. Studies often don't show rare or long-term effects that may become evident after a drug hits the market and many thousands of people are taking it. The FDA needs to do a better job of monitoring side effects at that point, the Harvard Health Letter article notes.

Perhaps most importantly, it has become clear to many that the FDA needs more options.

Right now, the FDA has three basic choices when safety concerns surface: It can recall a drug, threaten to recall it, or order the manufacturer to change the drug's label.

Some reformers would like to see the agency have further flexibility, says the article -- for instance, to temporarily suspend the sale of a drug while its safety record is examined.