WASHINGTON - Federal health officials announced Thursday that they are restricting the strength of Percocet, Vicodin and other popular prescription painkillers to prevent people from suffering severe liver damage from overdosing on one of the main ingredients.
The Food and Drug Administration asked drug companies to limit the amount of acetaminophen in all prescription products that combine the drug with other medications to no more than 325 milligrams per tablet or capsule.
Acetaminophen is included at much higher levels in a variety of prescription products with other ingredients, usually powerful painkillers known as opioids, such as codeine. A few examples are Tylenol with Codeine, oxycodone, which is also known as Percocet, and hydrocodone, which is sold as Vicodin.
"FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use," the FDA's Sandra Kweder said in a statement. "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."
The agency also is requiring manufacturers to update labels of all prescription products that combine acetaminophen with other substances to warn of the potential risk for "severe liver injury." All such products should start carrying "boxed warnings" - the agency's strongest warning for prescription drugs - about the potential dangers, the agency proposed.
The agency took the step at the recommendation of an advisory committee that met in June 2009 to consider the issue.
- The Washington Post