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What is an “Unexpected Adverse Drug Experience” in Texas?


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Previous posts here have discussed how the federal Food and Drug Administration plays an instrumental role in monitoring the safe manufacture and distribution of medications and other pharmaceutical products in Texas and throughout the United States. The FDA is charged with enforcing federal law and regulations concerning the manufacture, marketing and labelling of prescription drugs and certain over-the-counter products. However, the agency also requires that drug sellers and manufacturers continue to report any problems that occur with their products after they hit the market.

One occurrence that needs to be reported to the FDA is when an individual suffers an “Unexpected Adverse Drug Experience” (UADE). A UADE is any event that may be considered adverse to a person’s well-being that can be associated with the use of drug in a human being, even if it may not be considered drug-related. These adverse events may include death, creation of a life-threatening situation, a disfigurement that is significant or permanent, a birth defect, hospitalization, or another important medical event. The unexpected portion of the acronym means that the above adverse event is not included in the label of the product as a potential effect, or is of a greater severity or more specific nature than that listed in the labeling.

A serious UADE needs to be reported to the FDA within 15 days of there being an identifiable patient and an identifiable reporter, of a suspect drug and adverse event or fatal outcome. Reporters must also file quarterly and annual reports regarding both serious and non-serious UADEs. Failure to report, or filing of incomplete reports, can lead to the FDA taking regulatory action.

The purpose of such reporting is that there are often unexpected consequences to the taking of pharmaceuticals, even after they have received approval by the agency, and the FDA wishes to ensure, as much as possible, that product labelling is updated to accurately reflect risks, and so that it can evaluate the consequences of UADEs to determine if the risk-reward of the product needs to be evaluated. Unfortunately, when manufacturers or other reporters do not fulfill these requirements in a timely fashion, dangerous defective drugs may be left on the market to create more damage to the public.

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