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FDA Asks Drug Manufacturers to Limit Strength of Acetaminophen in Prescription Products
In the interest of patient safety, Food and Drug Administration (FDA) has asked drug manufacturers to limit the strength of acetaminophen in prescription drug products – which are predominantly combinations of acetaminophen and opioids – to 325 mg per tablet, capsule, or other dosage unit. In addition, FDA reports that the labels of all prescription drug products that contain acetaminophen will now include a boxed warning that highlights the potential for severe liver injury and a warning that highlights the potential for allergic reactions. FDA has taken these actions to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen. FDA notes that over-the-counter products containing acetaminophen are not affected by this action.
An FDA Drug Safety Communication provides specific information for health care providers, including dosing and patient counseling guidelines. While the maximum amount of acetaminophen in a prescription tablet, capsule, or other dosage unit will be limited to 325 mg, the total number of tablets or capsules that may be prescribed and the time intervals at which they may be prescribed will not change as a result of the lower amount of acetaminophen, notes FDA. FDA stresses to patients that they should not stop taking their prescription pain medicine unless told to do so by their health care provider. Additional information for patients is also included the FDA Drug Safety Communication.
