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FDA Calls for Withdrawal of Darvon® and Darvocet® Due to Serious Side Effects

Painkillers containing propoxyphene are being pulled from the market at the request of the US Food and Drug Administration (FDA). This includes the brand-name drugs Darvon and Darvocet (the latter also contains acetaminophen) and generic forms. Propoxyphene is an opioid used to treat mild to moderate pain.

The FDA’s decision came after a safety study showed that propoxyphene could cause significant changes to the electrical activity of the heart. “These changes, which can be seen on an electrocardiogram (ECG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death,” according to an FDA press announcement. “The available data also indicate that the risk of adverse events for any particular patient (even patients who have taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration, a change in medications, or decreased kidney function.”

Healthcare professionals have been asked to stop prescribing propoxyphene. Patients who are already taking it are advised not to withdraw abruptly, which can cause other symptoms, but consult with their healthcare professional.

For more information.

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