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Posted at 10:23 AM ET, 01/13/2011

FDA limits painkillers

By Rob Stein

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.

By Rob Stein  | January 13, 2011; 10:23 AM ET
Categories:  FDA, drug safety  
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Comments

This cautious restraint on acetaminophen would still leave the drug far more readily available than in Great Britain, where it's available over the counter in only small quantities.

Posted by: DaveoftheCoonties | January 13, 2011 11:15 AM | Report abuse

The FDA's action on acetaminophen is proof positive the federal agency cares little for consumer safety - considering the bulk of Tylenol related deaths are from OTC (over-the-counter) cold and fever products that nearly all seem to contain acetaminophen.

If you take two or more cold products plus a couple of drinks - you are risking death and/or severe liver damage.

Posted by: alance | January 13, 2011 11:37 AM | Report abuse

The more publicity this danger gets, the better. I remember when I had painful dental surgery and had already taken the prescription (controlled) medication and it still hurt. I took one (200 mg) acetaminophen on top of it but when my dentist called to see how I was doing he said my prescription med had acetaminophen in it and had me switch to ibuprofen as the second medication. I had to take both medication for 4 straight days (every 5 hours, my pain would wake me up to take the medicine!) before the swelling and the intense pain subsided so that would have been a lot of acetominophen.

Posted by: Georgetowner1 | January 13, 2011 11:48 AM | Report abuse

The regulations don't cover OTC meds which is stupid. I bet far more people overdose on OTC meds, than prescription. Your doctor can regulate how much you get and refuse to refill your prescription if you take too much and call to get a refill too early. There's nothing to stop you from taking 4 500mg of something you picked up at a store and just buying another bottle when that one's finished. Perhaps if they made more of an effort to educate people about what can happen to them people wouldn't double down on the dosage listed on the box.

Posted by: onlytheshadowknows1 | January 13, 2011 12:59 PM | Report abuse

I must admit I find myself laughing at this tidbit only because the makers of "Tylenol" , one of the brand names of Acetacetaminophen, Has know for 30 years (yes 30 ) of the potiential and often fatal liver toxicity of taking even the recommended daily dose of this pernicous substance. I know this from personal experience! In 19981 I began my long career as an critical care nurse at a well know and clinicaly advanced hospital in Phoenix Arizona. We knew back then of the harm the medication could do. I recall clearly the case of a 16 year old girl who had the misfortune of choosing Tylenol to overdose on an attempted suicide. She took only 15 tablets. It was in her medicine cabinet at home. When she arrived in the emergency room less than an hour later the protocols of detoxifying Patients who had overdosed on any number of sustances were stringently applied. Initially she survied her sucide attempt but the irreparable damage had been done. Within a week her liver had failed and she died a slow agonizing death...due to the ingestion of Tylenol.

I also recall a particularly onerous Ad campaign released by Tylenol, in a veiled effort to quash the evidence of the liver related hazards of even the recommended dose of their poisionous drug. They had a serious and rather corpulent woman in a business suit declare that "If you are not going to take Tylenol in its recommended dose do not take it at all!"
Well my friends, I have not taken a product containing Acetecetominophen (Tylenol) since 1982 and I strongly suggest you do the same thing!

As a final note I would like to add, I am sure you all have heard Tylonol proclaim their drug is so much safer than the others! Rather Nauseating is it not?

Posted by: anonpost1 | January 13, 2011 2:04 PM | Report abuse

Limiting the amount of Tylenol in OTC Products is only part of the solution. Providers need to remind patients that the medication they have been prescribed contains Tylenol /acetaminophen and they should not take additional Tylenol. Some people think these are two different drugs.This problem was described by Georgetowner 1 above. It is the responsibility of the prescriber to explain this. The Pharmacist should also remind the patient not to take Tylenol or acetaminophen with the prescribed drug.
Bunnymom

Posted by: bunnymom | January 14, 2011 5:34 PM | Report abuse

Limiting the amount of Tylenol in OTC Products is only part of the solution. Providers need to remind patients that the medication they have been prescribed contains Tylenol /acetaminophen and they should not take additional Tylenol. Some people think these are two different drugs.This problem was described by a reader above above. It is the responsibility of the prescriber to explain this. The Pharmacist should also remind the patient not to take Tylenol or acetaminophen with the prescribed drug.
Bunnymom

Posted by: bunnymom | January 14, 2011 5:36 PM | Report abuse

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