Manufacturers that produce prescription combination products containing acetaminophen are being asked by the FDA to limit the dosage to 325 mg per capsule or tablet to protect liver toxicity. Acetaminophen relives fever and pain and can be found in several OTC (over-the-counter) and prescription medications, such as codeine, Percocet (oxycodone), and Vicodin (hydrocodone).

The FDA (Food and Drug Administration) has informed manufacturers that all their prescription products containing an acetaminophen combination will need updated labels, warning about potential severe liver injury risk.

The FDA, in a communiqué today, added that OTC acetaminophen medications are not included in this action.

Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA's Center for Drug Evaluation and Research (CDER), said:

"FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use. Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States; many of which result in liver transplant or death."

There should not be any shortages of pain medication, the FDA informed, because this action will be phased-in over the 3-year period. The Agency added that combination drugs with a 325mg acetaminophen limit offer effective pain relief.

Kweder, said:

"There is no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by their health care provider. The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a 24-hour period."

According to the FDA, acetaminophen is commonly used as an OTC fever and pain drug, and is often combined with other OTC medications, such as those for coughs and colds. This FDA action does not affect these over-the-counter products.

Continued reports of liver injury prompted the FDA to take this measure. The FDA proposes that boxed warnings be added to all combo-prescription products containing acetaminophen.

In the vast majority of cases, severe liver injury reports have occurred in individuals who overdosed - took more than the prescribed acetaminophen-combo dose for a 24-hour period, took more than one acetaminophen-containing drug simultaneously, or consumed alcohol while on acetaminophen treatment.

A panel of experts (FDA advisory committee) concluded in June, 2009 that prescription medications containing acetaminophen should have a stronger warning about severe liver injury on their labels.

"FDA Panel Votes To Restrict Acetaminophen"
blog (June, 2009)

Acute overdoses of acetaminophen can cause potentially fatal liver damage. In rare cases, some people can experience damage with normal dosages. Risk of damage is heightened by alcohol consumption. Acetaminophen is the main cause of acute liver damage in North America and Europe, and accounts for the majority of drug overdose cases in the USA, UK, New Zealand and Australia.

Source: FDA



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