Prescription for safety

Natural Health, Sept-Oct, 1998 by Thomas J. Moore

Approximately 100,000 Americans die annually from taking prescription drugs. If you must take a drug, here's a plan to keep you alive.

AMY AND GARY KAUFMAN were on an idyllic vacation in the British Virgin Islands. One night as they got ready for bed, Amy had a question. Several months earlier, she had seen a dermatologist for an outbreak of hives. She was given a prescription for an antihistamine called Hismanal and was instructed to take one pill every morning. But that evening after dinner, her hives still bothered her. She asked Gary if she could take an extra tablet before going to bed. Since Gary is a neurosurgeon, Amy was asking a medical doctor as well as her husband. Gary will never forget his answer.

"One tablet can't kill you," he said. She took the tablet, and they went to bed.

When Gary woke up the next morning, his wife was dead. She was still lying beside him in bed, but her body was cooling to room temperature. The autopsy report said Amy's death was caused by cardiac arrest.

From the beginning, Hismanal was a leading suspect. The manufacturer had reported that cardiac arrests could occur with only one extra tablet. By May 1994, Hismanal had been linked to at least 82 cases of erratic heart rhythms so dangerous that they required hospitalization--even at the recommended one-tablet dose.

This tragedy might be easier to accept if it were a rare occurrence, and if measures were in place to prevent it from happening again. Unfortunately that's not the case. In 1993, more than 100,000 people died from taking drugs that their doctors prescribed for them. Researchers in a recent article in the Journal of the American Medical Association estimate that deaths from prescription medicines may be the fourth leading cause of mortality in the United States.

Perhaps even more disturbing than the mortality statistics is the fact that this problem is often overlooked by government safety officials. In fact, the National Center for Health Statistics reported that none of the 2,312,132 deaths that occurred in 1995 were attributed to prescription drugs. And even in cases where prescription drugs were probably responsible, the cause of death was listed as something else, such as cardiac arrest or infection.

Faced with these and other grim statistics, it's naive to think you can trust the medicines your doctor tells you to take. Once you know the facts, you are in a position, first, to question your doctor and your pharmacist about any drug you're told to take, and second, to act independently to protect yourself and your family from a tragedy like the one that struck Amy and Gary Kaufman.

Know the Risk

First, the facts:

* More than 1 million prescriptions are written every hour of the working day Over the course of a year, eight prescriptions will be written for every man, woman, and child in the United States.

* A nationwide survey conducted by the Food and Drug Administration (FDA) in 1994 found that more than 70 percent of patients received no information from their doctors about the possible adverse effects of the drugs they were prescribed. About one-third said they went home without even a doctor's instructions on how to take the medication.

* The U.S. government has more federal employees at the Naval Academy Laundry than they have to monitor the safety of approved drugs. And whereas the Federal Aviation Administration (FAA) assigns 10,000 inspectors to monitor the daily operations of 81 commercial air carriers, the FDA has a staff of just 54 people to monitor the safety of 3,200 approved drugs.

* In an article in the Journal of the American Medical Association, former FDA Commissioner David A. Kessler revealed that "only about 1 percent of serious events are reported to the FDA. It is not in the culture of U.S. medicine to notify the FDA about adverse events."

* Every year prescription drugs cause 1 million injuries so severe they require hospitalization, and another 2 million drug-related injuries occur during hospital care. In fact, over a lifetime of drug-taking, the average American has a 26 percent chance of being hospitalized from a drug injury. Long-term use of just one class of over-the-counter drugs--anti-inflammatory agents such as aspirin, ibuprofen, and Naprosyn--causes an estimated 70,000 hospitalizations every year.

What Can You Do?

First of all, you have to remember you are the boss. It is your body and ultimately your decision whether the benefits of a prescribed drug outweigh the risks. If there are benefits, you and only you will receive them. If there is harm, it's you who will get hurt. The notable exception is a medical emergency or hospital crisis where the need for rapid intervention makes it necessary to rely on the treating physician.

So how do you take charge? There are three key resources you can use to protect yourself: your doctor, your pharmacist, and the drug's own label.

Your Doctor

The next time your doctor prescribes a new drug, take the following steps:

1. Ask him why you need to take this drug. How will it benefit you?