Medication Errors

In a study recently published by the Journal of the American Medical Association (http://jamanetwork.com/journals/jama/article-abstract/2625319), researchers reported that nearly a third of drugs approved for usage by the Food and Drug Administration are subsequently found to pose safety risks.

To be approved, a medication must be shown to be both safe and effective. Achieving approval status however, often means the involvement of fewer than 1,000 patients and a follow up period of less than six months. Such a small sample size of patients can mean that a true cross section of society is not achieved. Moreover, such a brief follow up period may result in absence of any data regarding harmful side effects which appeared not months but years after patients took the medication.

During the course of their study, researchers reviewed over 200 drugs which had been approved over the last 15 years and of these, the FDA took action against 32%. These actions included a demand that the drug be taken off the market, a black-box warning be issued - the agency's most serious safety alert - and the issuance of special safety communications which advise both doctors and patients about newly identified concerns.

Of course, all drugs will likely have a side effect of some kind. Furthermore, it is probable that given the realities of the issuance of a new drug, there will be instances where a side effect, even a serious one, will remain undetectable even with a thorough clinical trial. The question will always be whether the risk/benefit balance is acceptable or not and that will depend on factors like medical need, available treatment alternatives, seriousness of side effects and frequency of occurrence. That being said, it is apparent that 32% is a number that is far too high and a response time of 4.2 years by the FDA can mean that it is already too late for many. The FDA and pharmaceutical companies can and should do better.

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