Finally! FDA Limits Acetaminophen in Prescription Analgesics
SOURCE: Medscape Medical News
By Robert Lowes
January 13, 2011 — The US Food and Drug Administration (FDA) today announced that it is asking drug makers to limit the amount of acetaminophen in prescription combination pain relievers to no more than 325 mg per tablet or capsule to reduce overdoses and the severe liver injury that can follow.
The decision, to be phased in over 3 years, affects dozens of prescription analgesics that contain both acetaminophen and another ingredient, typically opioids such as codeine, oxycodone, and hydrocodone. Some of these combination products now have as much as 750 mg of acetaminophen per dose.
The new dose restriction does not apply to numerous over-the-counter (OTC) pain relievers and cold, sinus, and cough medicines that contain acetaminophen. Normally, the maximum level allowed for these products is 500 mg, although a few extended-action pain relievers that are taken less frequently can go up to 650 mg.
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