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FDA Requires Labeling Changes on Acetaminophen Products, May Ban Two Prescription Painkillers

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To reduce the chance of liver damage from an overdose of the painkiller acetaminophen, the U.S. Food and Drug Administration (FDA) is asking makers of over-the-counter acetaminophen products to change how these drugs are labeled. In the future, drugs containing acetaminophen must clearly say so both on the container and on the container’s outer carton. In addition, labels must warn consumers about the dangers of taking more than the recommended dose of acetaminophen, taking more than one product containing acetaminophen at the same time, and taking acetaminophen with alcohol. Finally, the drugs have to warn people with liver disease and people taking the blood thinner warfarin that they should check with their doctor or pharmacist before taking acetaminophen.

The FDA is also considering reformulating and renaming two popular prescription painkillers -- Percocet and Vicodin -- because they contain acetaminophen. It is likely that the acetaminophen will be removed from these combination products, leaving just the opiate drug (pain medication) as the sole active ingredient. If acetaminophen is needed it can easily be taken separately in the appropriate amount. The FDA notes that patients who use Percocet and Vicodin long term often develop a tolerance to the drugs and require ever increasing doses to control their pain. This can lead to acetaminophen overdosing since the amount of acetaminophen in Percocet and Vicodin cannot be adjusted along with the patient’s recommended dose.

Acetaminophen as a single ingredient is sold under the brand names Tylenol and Excedrin. It is sold in various concentrations or strengths and as a secondary active ingredient in a variety of other drugs. If you have questions about a drug you are taking, talk to your doctor or pharmacist.


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