Drug Safety: A Bitter Pill
One day we hear about a newly introduced miracle drug; Greater Washington steers away from medica- the next thing we know it’s being pulled from the market. Before your tions once alarms are sounded, particularly when counseling geriatric patients who are often frail mouth can open to take a prescribed dose, fingers are already wiggling to assign blame, from the drug companies to the Food and Drug Administration. Following the recent publication of adverse Amid the flurry of explanations, accusations, calls for hearings, outcomes related to the diabetes drug Avandia, denials, apologies, endless reports of drug trials, and disturbing Dr. Patel decided to discontinue prescribing the details of suffering, the bewildered consumer is left wondering drug altogether even though many experts believe what to do, whom to believe, and whose advice to follow, especially its risks are only limited to patients with heart when the stakes are as high as life and death. Sadly, there is no “My reasoning,” explains Dr. Patel, “is that there are at least four older families of drugs in addition to insulin injection that I can use to The issue of drug safety and efficacy links directly to weighing control diabetes without exposing my patients the medical risks versus benefits of the drugs themselves and to cardiovascular risk. For the same reason I how the Food and Drug Administration (FDA) tests new drugs stopped prescribing Vioxx even before the final According to Janet Woodcock, M.D., director of the FDA’s Center time, on-site medical staff of the Hebrew Home of Drug Evaluation and Research, “safe does not mean harmless.
Every drug comes with risks, and our tolerance for risk is higherfor drugs that treat serious and life-threatening illnesses.” Where to find information about drug safety
Speak candidly with your physician about the At what point is a drug considered “safe?” An important 2002 study published in the value and risks of any recommended prescription Journal of the American Medical Association (JAMA), states that it may take years for medication. To learn more about drug safety in significant adverse drug reactions (ADRs) in widely marketed drugs to be reported.
general, start your research at these websites: What’s more, they point out, “only half of newly discovered serious ADRs are detected • Food and Drug Administration, Center for Drug and documented in the Physicians’ Desk Reference within seven years after drug
So, if you want a guarantee of a drug’s safety, some scientists feel you might have to • The Health Research Group, a division of Public wait at least seven years from a drug’s FDA approval date.
The JAMA study recommends that “clinicians should avoid using new drugs when older, • MedLine Plus, a service of the National Library similarly efficacious agents are available.” In addition, if patients insist on using a new of Medicine and the National Institutes of drug, they should be fully informed of its “limited experience and safety record.” ■ Health:, owned and operated
“We’re really not doing a good enough job and demanding good data before a
drug gets approved. They tend to be tested in healthy people against sugar pills
for a brief period of time, and that’s just not the information that patients and
doctors need to have to judge that drug once it’s out there.”

— Dr. Jerry Avorn, M.D., Harvard Medical School


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