Drug Safety
By David Borenstein, MD
Also see our Drug Safety Q & A
A number of drugs, including anti-depressives, and nonsteroidal anti-inflammatory drugs including Cox-II inhibitors, have appeared in the media because of new concerns involving side-effects. The anti-depressives were associated with an increased risk of suicide, while concerns were raised regarding an increased risk of heart attacks and strokes with aspirin-like medicines, including Vioxx.
Every drug has side-effects. The decision about taking a drug has to balance the benefit of the medicine against its potential toxicities. Some patients have great benefit from a drug because they have very little risk of side-effects. In other individuals, the choice of the same drug would not be beneficial because of the increased susceptibility to side-effects. Your doctor has the information about your condition to make the best estimate of this risk-benefit calculation.
New information is generated regularly about the benefits and risks of medicines. For example, the Cox-II inhibitor, Celebrex, has recently been approved by the Food and Drug Administration for the treatment of ankylosing spondylitis, an inflammatory disorder of the spine. The cardiovascular risks associated with the nonsteroidal drugs are under active investigation. Recent studies have noted the relationship of increased blood pressure and anti-inflammatory drugs. Hypertension, high blood pressure, is a know risk factor for the development of strokes and heart attacks. Your doctor will have to decide whether the potential risk of hypertension is overtaken by the benefits of prolonged pain control. Another factor to be considered is that hypertension can be controlled by a number of means. Losing weight, discontinuing smoking, eating less salt can have beneficial effects on lowering blood pressure. This example shows how it is possible to have the benefits of a drug while limiting the risks.
The importance of side-effects has been a concern of the Food and Drug Administration (FDA), the government agency that is responsible monitoring drug therapy. The FDA is undergoing an evaluation by the Institute of Medicine to determine the best way to monitor drug safety. This report is due by the end of the year. In anticipation of improving public information about drugs, the FDA has just revamped the package insert, the script included with the drug that contains the way to take the medicine. The new package insert will have a summary or highlights section, a doctor's counseling section, and prescribing information. The risks associated with taking a drug will be easier to recognize.
In summary, ever drug has benefits and risks. The choice of a drug should be made after a discussion with your doctor. You should only take your medicine as prescribed and for as long as pain is present the choice should not be made based upon information from the newspaper, television, or the neighbor down the street. Let your doctor know how you are doing. Any medicine can be stopped if there are problems