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New side effects for already approved drugs

For some, the list of side effects for a particular drug may be alarming. Others might take comfort from the feeling that the drug has been thoroughly tested to reveal its potential dangers. One of the main reasons those side effects are listed is so that patients and their doctors can keep an eye out for adverse reactions associated with a medication. Unfortunately, many new drugs are approved without a comprehensive understanding of side effects, even deadly ones. According to a recent study, 32 percent of the prescription drugs approved by the FDA from 2001 to 2010 did not warn patients of all the potential side effects.

When drugs are tested

Depending on your point of view, the U.S. Food and Drug Administration is either doing an excellent job of monitoring drugs already on the market, or a poor job of testing new drugs before approving them. The truth probably lies somewhere in between. It is undeniable that the testing done on new drugs is not sufficient to uncover the potential harm to consumers. While many of the side effects discovered after approval were mild, some were serious enough to cause fatalities. It is fair to question what went wrong in the cases where a drug was approved, but later recalled after killing some of the people who took it.

The study found that new side effects were acknowledged an average of four years after a drug was approved. Whether an additional four years of testing would be sufficient or advisable is an open question. Industry insiders and consumer groups have been pushing for faster approval, rather than additional testing. At the very least, patients should be aware that a drug that is new or relatively new to the market may carry risks that are not displayed on the label. If you are taking a new drug, you are, in a way, acting as a guinea pig for the drug manufacturer.

 

Source: AP News, “Study: Side effects emerge after approval for many US drugs,” by Lindsey Tanner, 9 May 2017

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