FDA limits painkillers
Federal health officials Thursday announced they were restricting the strength of some of the most popular prescription painkillers to prevent people from suffering severe liver damage from one of the main ingredients.
The Food and Drug Administration is asking 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 in each 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," said Sandra Kweder, the deputy director of the Office of New Drugs in FDA's Center for Drug Evaluation and Research 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 agency convened the committee after receiving reports of patients suffering liver damage from acetaminophen.
"Most of the cases of severe liver injury occurred in patients who took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period, took more than one acetaminophen-containing product at the same time, or drank alcohol while taking acetaminophen products," the agency said
The elimination of products containing higher doses of acetaminophen will be phased in over three years and "should not create a shortage of pain medication," the agency said. "The FDA believes that prescription combination products containing no more than 325 mg of acetaminophen per tablet are effective for treating pain."
Kweder added: "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."
The action does not affect over-the-counter products containing acetaminophen, which also lowers fevers. It is widely used as an over-the-counter pain and fever medication, and is combined with other over-the-counter ingredients, such as cough and cold ingredients.
Sidney Wolfe of the Public Citizen Health Research Group, a consumer advocacy group, criticized the agency for failing to also take steps to address over-the-counter products containing acetaminophen.
"It is inexcusably poor judgment on the part of the FDA to have failed to take action concerning this major source of acetaminophen consumption and, consequently, acetaminophen toxicity," he said.
For a video about the announcement, click here.
| January 13, 2011; 10:23 AM ET
Categories: FDA, drug safety
Save & Share: Previous: Studies show that for kids' ear infections, antibiotics work better than waiting
Next: Is eye opening really significant?
Posted by: DaveoftheCoonties | January 13, 2011 11:15 AM | Report abuse
Posted by: alance | January 13, 2011 11:37 AM | Report abuse
Posted by: Georgetowner1 | January 13, 2011 11:48 AM | Report abuse
Posted by: onlytheshadowknows1 | January 13, 2011 12:59 PM | Report abuse
Posted by: anonpost1 | January 13, 2011 2:04 PM | Report abuse
Posted by: bunnymom | January 14, 2011 5:34 PM | Report abuse
Posted by: bunnymom | January 14, 2011 5:36 PM | Report abuse