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Dr. Bob is Robert Hsiung, MD,
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Posted by Phillipa on January 15, 2014, at 17:45:19
News Alerts > Medscape Medical NewsFDA Asks Docs to Limit Acetaminophen in Prescription Meds
Megan Brooks
DisclosuresJanuary 15, 2014
The US Food and Drug Administration (FDA) is asking healthcare professionals to stop prescribing combination prescription pain relievers that contain more than 325 mg of acetaminophen per tablet, capsule, or other dosage unit, citing the risk for liver damage.
The action targets prescription analgesics that contain both acetaminophen and another ingredient, typically opioids such as codeine, oxycodone, and hydrocodone. Some of these combination products now have as much as 750 mg of acetaminophen per dose.
In a statement, the FDA said, "There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury."
"Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death," they added.
The FDA said cases of severe liver injury with acetaminophen have occurred in patients who took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period; took more than 1 acetaminophen-containing product at the same time; or combined alcohol with acetaminophen products.
Following Up on Request
As reported by Medscape Medical News, in January 2011, the FDA asked manufacturers of prescription combination drug products containing acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule by January 14, 2014.
More than half of manufacturers have voluntarily complied with the FDA request. "However, some prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit remain available," the FDA said.
"In the near future FDA intends to initiate proceedings to withdraw approval of prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit that remain on the market," the agency said.
In the meantime, the FDA recommends that healthcare providers consider prescribing combination drug products that contain 325 mg or less of acetaminophen.
The regulator also recommends that when a pharmacist receives a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit that they contact the prescriber to discuss a product with a lower dose of acetaminophen. "A two tablet or two capsule dose may still be prescribed, if appropriate. In that case, the total dose of acetaminophen would be 650 mg (the amount in two 325 mg dosage units)," the FDA said.
"When making individual dosing determinations, health care providers should always consider the amounts of both the acetaminophen and the opioid components in the prescription combination drug product," they add.
OTC Products on Radar
Information from Industry
The FDA said it will address over-the-counter (OTC) pain relievers and cold, sinus, and cough medicines that contain acetaminophen in a separate regulatory action. Normally, the maximum level allowed for these products is 500 mg, although a few extended-action pain relievers that are taken less frequently can go up to 650 mg.
"Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much," the FDA warns.
Healthcare providers and pharmacists who have questions about these products are encouraged to contact the Division of Drug Information at 888.INFO.FDA (888-463-6332) or druginfo@fda.hhs.gov.
To report problems with these or other products, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
Posted by jono_in_adelaide on January 16, 2014, at 21:54:46
In reply to FDA Limit Amount Tylenol In Both Pain + OTC Produc, posted by Phillipa on January 15, 2014, at 17:45:19
Thats strange - in most of the world, you can only get 500mg tablets of paracetamol/acetaminophen (Tylenol, Panadol and hundereds of other brands) and we dont seem to have an epidemic of liver damage
Perhaps thats because strong narcotic painkillers here usualy dont contain acetaminophen/paracetamol, so there isnt any reason for people to excede the recomended dose?
Posted by bleauberry on January 17, 2014, at 6:38:25
In reply to FDA Limit Amount Tylenol In Both Pain + OTC Produc, posted by Phillipa on January 15, 2014, at 17:45:19
Somebody should put a limit on the FDA. They have extremely too much power and politics to be dealing with medical issues. And not a great track record either.
In their effort at the FDA to do whatever they do, people die. People get sicker. People are denied opportunities to get well. But none of that matters to them. They do not care about people. They care about their jobs and stature.
Me for example. If my journey had been according to FDA and CDC guidelines....which it was during the psychiatric medication part of my journey....it would have been a less-than-desired outcome. And that is exactly what happened.
Had I not followed FDA and CDC guidelines, as I currently am not....they frown on longterm antibiotics....I would get a lot better! And I am on the road of getting better.
Zero thanks to FDA. Zero thanks to CDC. Go home guys. Had you had your way, I would either be in a straight jacket, a wheel chair, or dead!
Those organizations have no place having the sort of power they display. They would have killed me if I had not called them on their falsehoods. They put forth facts as if they were facts....go look at the details in the fine print...they aint facts, they are opinions and editorials!
imo. patients should do their own research for validation.
Posted by ed_uk2010 on January 17, 2014, at 15:02:51
In reply to Re: FDA Limit Amount Tylenol In Both Pain + OTC Produc, posted by jono_in_adelaide on January 16, 2014, at 21:54:46
>Perhaps thats because strong narcotic painkillers here usualy dont contain acetaminophen/paracetamol, so there isnt any reason for people to excede the recomended dose?
Yes, exactly. In the treatment of severe chronic pain, acetaminophen/paracetamol and opioids should be given as separate tablets. Paracetamol should be Rxed at 650mg or 1000mg up to four times a day (or 500mg four times a day in very elderly pts with low body weight) + an opioid at an appropriately titrated dose. Combo tabs can lead to paracetamol overdose if pts take more than the recommended dose in order to achieve an adequate opioid dose.
Opioids often require a great deal of dosage adjustment to control chronic pain adequately, there is no standard dosage whatsoever. Paracetamol does not require much adjustment at all: 650mg or 1000mg four times a day is suitable for most pts. The use of combo tablets should therefore be restricted to pts whose para and opioid doses can be safely achieved by using them. Pt education is also important to avoid accidental use of other paracetamol-containing products (flu remedies etc) at the same time.
Posted by Phillipa on January 17, 2014, at 18:07:44
In reply to Re: FDA Limit Amount Tylenol In Both Pain + OTC Produc, posted by ed_uk2010 on January 17, 2014, at 15:02:51
Ed what opiods are given in England, and for headaches I usually take ibuprophen but they say it causes heart disease now? And bleeding? PJ
Posted by baseball55 on January 17, 2014, at 19:24:38
In reply to Re: FDA Limit Amount Tylenol In Both Pain + OTC Produc, posted by ed_uk2010 on January 17, 2014, at 15:02:51
1000mg, 4x/day is way too much. 4 grams is the absolute maximum allowed before causing liver failure. In the US, acetaminophen generally comes in 375mg tablets.
Don't they sell codeine with tylenol (can't recall the UK name) OTC in the UK? I met people in London AA groups who abused it and it's a wonder they didn't destroy their livers.
Posted by baseball55 on January 17, 2014, at 19:25:55
In reply to Re: FDA Limit Amount Tylenol In Both Pain + OTC Produc » ed_uk2010, posted by Phillipa on January 17, 2014, at 18:07:44
> Ed what opiods are given in England, and for headaches I usually take ibuprophen but they say it causes heart disease now? And bleeding? PJ
Ibuprofen causes heart disease? Never heard of that. In high doses used for extended periods, can cause ulcers.
Posted by baseball55 on January 17, 2014, at 19:36:01
In reply to Re: FDA Limit Amount Tylenol In Both Pain + OTC Produc, posted by bleauberry on January 17, 2014, at 6:38:25
So are you saying that people should go inspect pharmaceutical factories themselves and have advanced chemistry degrees to assess quality? Instead of letting the FDA do this? And the CDC? People should just compile epidemiology data themselves, to see if there's an outbreak of salmonella or virulent influenza?
So I guess in your perfect world, everyone would have a PhD in bio-chemistry and epidemiology and would keep extensive testing/lab equipment in their homes, eliminating the need for public oversight.
Just because you don't agree with the recommendations of doctors (not the FDA or CDC - who do not do diagnosis and prescribing), is no reason to attack the FDA and, especially not, the CDC.
Posted by Phillipa on January 17, 2014, at 19:56:05
In reply to Re: FDA Limit Amount Tylenol In Both Pain + OTC Produc » bleauberry, posted by baseball55 on January 17, 2014, at 19:36:01
We need the FDA to approve or remove unsafe meds form the market. And they are the ones who place Black Box Warnings on Meds.
As for ibuprophen causing heart disease let me see if can find. Phillipa
Posted by jono_in_adelaide on January 25, 2014, at 6:21:43
In reply to Re: FDA Limit Amount Tylenol In Both Pain + OTC Produc, posted by ed_uk2010 on January 17, 2014, at 15:02:51
Phillipa - Ibuprofen has only linked with heart disease when taken in high doses (2 tabs four times a day) for periods exceeding several weeks. Occasionaly taking 2 tablets for a headache is perfectly safe re heart disease, and it is a much better analgesic than acetaminophen/tylenol
Posted by Phillipa on January 25, 2014, at 21:39:04
In reply to Re: FDA Limit Amount Tylenol In Both Pain + OTC Produc, posted by jono_in_adelaide on January 25, 2014, at 6:21:43
Jono good cause this Is the only thing that works for a headache thanks. Phillipa
Posted by jono_in_adelaide on January 26, 2014, at 16:46:50
In reply to Re: FDA Limit Amount Tylenol In Both Pain + OTC Produc, posted by jono_in_adelaide on January 25, 2014, at 6:21:43
You could also try Excedrin - this is aspirin, acetaminophen and caffeine - the aspirin would actually reduce the risk of heat attack and stroke, and its very good for headaches and other pains
Its available as generic (uualy as "headache relief" at about half the price of the brand name)
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