How Safe Are Your Prescription Pills?

Becky Long, 63, of Tampa, Fla., has been taking the prescription drug Celebrex for her arthritis for the past two years. So when she heard the news last week that the drug, along with another painkiller called Vioxx, might be associated with an increased risk of heart attack, she called her doctor right away. Her biggest concern was not what you might expect, however. "The first thing I thought of was that Celebrex gave me my life back," says Long, who used to find climbing stairs impossible but has since felt well enough to travel to Nepal. "What would I do without it?"

Long is not the only one asking questions. Patients with a variety of concerns have been flooding physicians' phone lines with inquiries about Celebrex and Vioxx, two examples of a heavily advertised new class of analgesics called COX-2 inhibitors that are supposed to be easier on the stomach than aspirin. Some folks wanted to discontinue their medication; others just needed to hear that the potential cardiac threat was only theoretical and not proved.

Certainly, second thoughts about the safety of new prescription drugs, not just Celebrex and Vioxx, are understandable. Three weeks ago, Baycol, one of the popular group of cholesterol-lowering drugs known as statins, was recalled because of an increased risk of rare but potentially fatal muscle problems. The same side effect--albeit at even lower rates--has been seen with the five other statins that remain on the market. But so few doctors and patients seem to know about the risk that last week, the Public Citizen Health Research Group, a consumer-advocacy organization, petitioned the Food and Drug Administration to require more prominent warnings on all the statins.

The truth is that no medication--not even a nonprescription drug like aspirin--is 100% safe. Whether you realize it or not, whenever you take a drug, you are weighing the potential benefits against the possibility that the medicine can hurt you. So it pays to find out as much as you can about any drugs--including herbal remedies--you are taking.

When the COX-2 inhibitors hit the market in 1999, doctors and patients alike expected a lot from the little painkillers. The old standbys--which include aspirin and ibuprofen (Advil)--can tear up the lining of the stomach and cause serious bleeding disorders. These side effects occur when a protective enzyme called cyclo-oxygenase 1, or COX-1, is suppressed. Because the COX-2 inhibitors don't affect COX-1, it was expected that they would have fewer side effects.

Scientists are still debating whether that is the case. When the FDA approved the COX-2 inhibitors, it required Merck, the manufacturer of Vioxx, and Pharmacia, which markets Celebrex jointly with Pfizer, to include warnings about potential gastrointestinal problems.

Merck and Pharmacia were convinced that their medications had a better side-effect profile and submitted additional data to an FDA advisory panel last February. But the extra information raised new red flags for Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who was consulted by the FDA. Nissen noticed what seemed like a high number of heart attacks and other cardiovascular problems in the companies' data. Together with Dr. Eric Topol and Dr. Debabrata Mukherjee, Nissen decided to look into the matter further.