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The agency now has reviewed the data from that study, which show that, even when taken at recommended doses, propoxyphene causes substantial changes to the electrical activity of the heart. These changes, which can be seen on an electrocardiogram (ECG), can improve the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, which includes sudden death. The obtainable data also indicate that the risk of adverse events for any specific patient (even patients who have taken the drug for numerous years) is subject to change based on little changes in the health status of the patient, like dehydration, a change in medications, or decreased kidney function.
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