Vicodin and other blended painkillers are at fault in many unintentional overdoses. Image: Flickr / jayqueue / CC-BY-SA

In a ruling announced on Thursday, the FDA ordered limits on a Vicodin ingredient. Acetaminophen, a painkiller found in everything from Vicodin to cold medicine, will be limited. This new limit is intended to cut down on the number of unintentional overdoses.

FDA orders limits on Vicodin ingredient

The FDA ruling will limit the amount of acetaminophen in each painkiller capsule. The current limit is 700 milligrams per pill. The new limit will allow no more than 325 milligrams per capsule or dose. Acetaminophen is a drug used to treat everything from headaches and fever to sore throats. Drugs like Vicodin, Percocet and hydrocodone generics mix acetaminophen with narcotics. Many narcotic painkillers also contain acetaminophen, but many patients may take additional acetaminophen, causing an overdose.

Problems with standard labeling

The limitation on acetaminophen comes partially from the lack of standard labeling. On some pills, acetaminophen is labeled as APAP, on others it is labeled with different abbreviations. This lack of standard labeling practice means it is tough for patients to avoid overdoses. The restrictions for the amount of the painkiller in prescriptions is likely to be followed up with a boxed warning. Acetaminophen is the leading cause of liver failure in the USA. The FDA estimates that there are about 120 deaths a year from overdoses of the drug.

Over the counter products with acetaminophen

Though the FDA is putting strong warnings on boxes and limiting the amount of painkillers in prescription medication, it is not limiting all drugs that contain acetaminophen. Many over the counter medications, such as Tylenol, will still contain acetaminophen above and beyond the 325 milligram limit. High-dose over the counter drugs have up to 500 milligrams per capsule. In 2009, an FDA panel voted to eliminate these narcotic / acetaminophen combinations entirely. The FDA, however, has decided to limit the amount of acetaminophen, rather than eliminating the drugs from the market.



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