Drug safety concerns raising questions

Published 12:00 am Thursday, February 3, 2005

When the popular non-steroidal anti-inflammatory (NSAID) arthritis drug Vioxx was pulled off the market on Sept. 30 because a study showed potential for increased risk of heart problems, questions about the safety of many drugs were raised. The Food and Drug Administration advised the more than two million patients worldwide using Vioxx to consult with a physician about alternative medications. However, doctors may not know how to direct their patients when it comes to arthritis medications and other pain relievers.

&uot;Since Vioxx is no longer on the market, physicians are not prescribing it anymore," Jeffrey N. Katz, M.D., a rheumatologist at Brigham and Women's Hospital in Boston, Mass., said. "As there is uncertainty about which of the alternatives makes most sense, I recommend having detailed conversations with patients and making a joint decision based on their preferences and what we know at this point."

The safety and efficacy of the recently developed group of NSAIDs called COX-2 selective agents, which includes Celebrex, Bextra and Vioxx, will be scrutinized by the FDA in a special three-day February meeting. Questions have also been raised about the safety of older NSAIDs, like naproxen (available under trade names such as Aleve and Naprosyn) after a study involving the drug showed some evidence of increased risk of cardiovascular events, when compared to placebo.

The risks of these drugs may be different for women and men, but few studies have been conducted to examine gender differences.

"There are no known studies that compare women and men on Vioxx, and sex differences were not mentioned when studies about this and other drugs raised concerns about heart problems," Sherry Marts, Ph.D., vice president of scientific affairs at the Society for Women's Health Research in Washington, D.C., said.

"This is a problem because heart disease affects women and men differently," Marts said. "It kills 500,000 American women each year, over 50,000 more women than men, and strikes women about 10 years later than men. Women are more likely than men to have a second heart attack within a year of the first one. That's why doctors and patients need more detailed information about drugs that can cause heart problems."

Many of the drugs pulled from the market in recent years have had greater health risks for women, according to a 2001 drug safety study conducted by the United States General Accounting Office. The risks may be related to physiological or hormonal differences between men and women, but more studies are needed to make appropriate conclusions.

"For some of the drugs that were withdrawn, there were more adverse events in women, but more women took the drug, so there was no way to tell if the higher occurrence was due to biology or just the number of women taking it," Marts said. "However, for some drugs, the GAO found that even though similar numbers of men and women took the drug, more adverse events were reported in women."

Whether you are a woman or a man, taking over-the-counter or prescription drugs poses risks. The FDA will only approve a drug if its clinical benefits outweigh the potential to do harm.

When a drug is pulled off the market, patients can be confused. Medications once thought to be safe are all of sudden unavailable and the use of related medication may seem undesirable. It is vital for patients to speak with their doctors about the pros and cons of specific medications and to understand the risks associated with taking any drug.

Open communication is an integral part of good health care. Marts recommends that patients ask their doctors the following questions when evaluating the advantages and disadvantages of potential medications:

€ How long has this drug been on the market?

€ How much experience do you have prescribing this drug?

€ What side effects have your other patients reported? What serious side effects should I look for?

€ Do you know of any particular problems and risks for women (or men) taking this drug?

The goal is to fully understand your medications and the care you receive to maximize the benefits and reduce the potential harm to your health.