Prescription Peril

October 2009

by Molly Ginty

A 54-year-old woman took a heart drug that was not approved for her condition—and developed such severe lung problems that she can now only breathe with an oxygen tank.

A 60-year-old health care worker used a high blood pressure drug that slowed her pulse to half its normal, healthy rate.

A 79-year-old grandmother suddenly became so confused that she couldn’t finish her sentences. The cause proved not to be aging, but a tranquilizer that triggered dementia in so many patients that it had to be taken off the market.

Five years ago this month, the pain­killer Vioxx was pulled from pharmacy shelves because studies revealed that it doubled the risk of heart attacks and strokes in the 20 million Americans who were taking it. But despite safety scandals surrounding Vioxx and other big-name drugs—and despite measures meant to make medications safer—problems per­sist that could put you and your family in prescription peril.

“When the Food and Drug Adminis­tration approves a drug, it means that in most cases, the drug’s benefits outweigh its risks,” says Sheila Weiss Smith, Ph.D., director of the Center for Drug Safety at the University of Maryland School of Pharmacy in Baltimore. “But this is by no means a guarantee that any drug is 100 percent safe.”

Every year, Americans experience more than 2 million adverse drug reac­tions. From the diabetes medication Avandia (linked to heart problems) to the anti-psychotic Zyprexa (tied to increased diabetes risk), many common drugs have stirred controversy. Adverse events typically strike women (who take more prescription drugs than men) and people over age 65 (who take an average of six medications per day). But studies show that 80 percent of all drug patients have problems with their prescriptions, 50 percent take doses that are too high or low, and 44 percent take drugs in combi­nations that can be harmful.

When drug use goes awry, side effects can include heart problems, ulcers, memory loss—even paralysis. Take any medication in the wrong amount, at the wrong time, or in combination with other drugs that don’t mix well with it, and short-term discomfort—or long-term debility—can result.

Problems associated with prescription drugs have tripled since 1998, according to a study in the Archives of Internal Medicine. “Better science means drugs are getting more potent,” says study author Curt D. Furberg, M.D., Ph.D., a professor of public health at Wake For­est University School of Medicine. “And because of this increased potency, we also have an increase in adverse events.”

Experts say the rapid pace of health care in the United States is only fuel­ing the problem. Research shows that the average doctor’s visit lasts just 17 minutes—barely enough time to conduct a physical exam, much less explain pre­scribed medications. Physicians neglect to mention drugs’ side effects two-thirds of the time.

Attempts at government over­sight have also fallen short. In 1992, in response to complaints that life­saving drugs such as HIV medica­tions were mired in the approval process, authorities took steps that cut the average FDA drug approval time in half. This saved up to 310,000 years of life for patients.

But priority-reviewed drugs, according to Harvard studies, became three to five times more likely to be withdrawn for safety reasons. Fast-tracked drugs that had to be banned include the painkillers Vioxx and Bextra, the diabetes drug Rezulin, and the cholesterol-buster Baycol.

The good news? Newer chang­es in oversight show more promise. In 2007, after a flurry of drug safety scandals, the FDA improved its database so people could report adverse events online instead of fill­ing out paperwork. It revamped its Web site to alert the public about potential problems in real time instead of after the fact. Now the agency is ramping up research to determine whether a drug is toxic before a patient ever takes it.

Even better news? You can dramatically reduce your risk of adverse drug events by taking a few simple steps:

• ASK your doctor the questions he or she may not take time to raise. What is your condition? What are your treatment options? What are these options’ risks and benefits? Why should you use one particu­lar drug rather than other similar drugs on the market?
• MENTION other medications you’re taking before your doctor prescribes a new one. Include over-the-counter remedies and supplements such as allergy pills, vitamins, and herbs, which can affect how your body processes prescription drugs.
• OPT for older medications if your condition doesn’t require cutting-edge drugs—and if your doctor agrees that tried-and-true medica­tions are safe options for you.
• LEARN everything you can about the drugs you’re taking. Read patient information leaflets and search health Web sites for more info.
• TAKE the lowest dose possible of any given drug, which lets you watch for side effects and slowly increase the dosage to achieve desired results.
• FIND out if you’re taking a drug “off-label” for a purpose that has been scientifically studied, but is not yet FDA-approved. This prac­tice is common—especially with car­diac and anticonvulsant drugs. But it may put you at increased risk for adverse effects.
• RELY on the same pharmacist and ask him or her to help explain how prescriptions work.
• DON’T discount side effects if you think you’re experiencing them.

“Pick up the phone and call your doctor—or head to the emergency room right away,” advises Weiss Smith.

Molly M. Ginty lives in New York. Her work has appeared in Ms., Marie Claire, Redbook, and Women’s eNews.