The Food and Drug Administration is imposing a new limit on dosages of prescription drugs that contain acetaminophen.The agency asks that a limit of 325mg per tablet or capsule be observed by manufacturers in order to protect the liver.Codeine,Percocet and Vicodin are among the prescription drugs that will be affected by the new rule.
In addition to the dosage limits,manufacturers must update warning labels to warn about the potential risk of severe liver injury.An FDA deputy director,Sandra Kweder,MD,said that the agency is taking the action to make the prescriptions 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 is no immediate danger to those currently taking those drugs,Dr.Kweder continued,and they should continue to use them as prescribed.Liver injury mainly occurs when patients take multiple products containing acetaminophen at one time and exceed the current limit of 4,000mg within a 24 hour period.
The FDA was concerned about continuing reports of liver injury.Rarely,even normal usage of the medications can cause liver damage.Acetaminophen is the number one cause of acute liver damage in North America and Europe.
OTC drugs such as Johnson and Johnson's Tylenol will not be affected by the new regulations.The new limit on prescription acetaminophen combinations will be phased in over three years.
Johnson and Johnson(JNJ)
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