Big Changes Coming for Tylenol Users

Johnson & Johnson (JNJ) said Thursday that it's reducing the maximum daily dose of its Extra Strength Tylenol pain reliever to lower risk of accidental overdose from acetaminophen, its active ingredient and the top cause of liver failure.

The company's McNeil Consumer Healthcare Division said the change affects Extra Strength Tylenol sold in the U.S. - one of many products in short supply in stores due to a string of recalls.

Starting sometime this fall, labels on Extra Strength Tylenol packages will now list the maximum daily dose as six pills, or a total of 3,000 milligrams, down from eight pills a day, or 4,000 milligrams. Beginning next year, McNeil will also reduce the maximum daily dose for its Regular Strength Tylenol and other adult pain relievers containing acetaminophen, the most widely used pain killer in the country.

Besides Tylenol, acetaminophen is the active ingredient in the prescription painkillers Percocet and Vicodin and in some nonprescription pain relievers, including NyQuil and some Sudafed products. It's found in thousands of medicines taken for headaches, fever, sore throats and chronic pain.

But people taking multiple medicines at once don't always realize how much acetaminophen they are ingesting, partly because prescription drug labels often list it under the abbreviation "APAP."

Two years ago, a panel of advisers to the Food and Drug Administration called for sweeping restrictions to prevent accidental fatal overdoses of acetaminophen.

Then in January, the FDA said it would cap the amount of acetaminophen in Vicodin, Percocet and other prescription pain killers at 325 milligrams per capsule - just under half the 700 milligram maximum of some products on the market then. The agency also said it was working with pharmacies and other medical groups to develop standard labeling for acetaminophen.

"Acetaminophen is safe when used as directed," Dr. Edwin Kuffner, McNeil's head of over-the-counter medical affairs, said in a statement. "McNeil is revising its labels for products containing acetaminophen in an attempt to decrease the likelihood of accidental overdosing."

Excessive use of acetaminophen can cause liver damage. In the U.S., it's blamed for about 200 fatal overdoses and sends 56,000 people to the emergency room each year.

McNeil spokeswoman Bonnie Jacobs said other makers of pain relievers are likely to make similar changes to their product labels.

Extra Strength Tylenol is manufactured at a J&J factory in Las Piedras, Puerto Rico, where production has been decreased for months because the FDA, concerned about manufacturing and quality problems, is requiring additional reviews and approvals before medicines can be shipped. J&J said shipments of Extra Strength Tylenol should ramp up in the latter part of this year and throughout next year.

Las Piedras is one of three factories implicated in most of the 25 Johnson & Johnson recalls since September 2009, involving tens of millions of bottles of Tylenol and other nonprescription drugs made by McNeil. Several prescription drugs, hip implants and contact lenses made by other J&J subsidiaries also have been recalled.

The recalls, for quality problems ranging from metal shavings and improper levels of active ingredients in some medicines to packaging with a nauseating odor, resulted in a consent decree between McNeil and the FDA this spring.

As a result, Las Piedras and a second factory, in Lancaster, Pa., are under additional scrutiny. The third factory, in Fort Washington, Pa., made children's medicines such as liquid Tylenol. It has been closed since April 2010 and is being gutted and completely rebuilt.

Jacobs said the label changes are not related to the recalls.

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18 Comments

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rhadden566

Combination drugs should not be allowed. They are simply a maketing tool and are usually more expensive than their components. Really, how much more difficult is it to take 2 rather than 1 pill? The risks far outweigh any benefit.
An MD's opinion

July 31 2011 at 9:51 PM Report abuse rate up rate down Reply
wwjdsfcj

Let me tell you what, even pharmacists and docs seem to be clueless of the facts about tylenol. I just had a hip replacement and the pharmacy at the hospital pushed Percocet on me in spite of the fact that I wanted the same med without the tylenol in it. When I called my docs office after I got home they told me I could take 2 percocet every 3 hours up to TEN a day!
What are you kidding me?
Fortunately I was a nurse 25 years ago and keep up on medical/pharmecutical topics and issues.
I had to be very assertive in my request for a new prescription for the percocet without the tylenol. They finally called in a five day Rx for oxycodone (percocet w/o tylenol).
Bottom line; if you are not your own advocate in your medical care, you are not going to do well. It pays to be knowledgeable about what your "caregivers" are doing for you. You cannot afford to just put yourself into a physicians capable hands. Those days are gone forever.

July 31 2011 at 10:09 AM Report abuse +1 rate up rate down Reply
1 reply to wwjdsfcj's comment
Dave

I'm surprised to hear that a 'scrpt for oxy can be "called in." In many places, you need to have the written prescription -- if you can even find a pharmacy to fill it. I'm glad to hear that you were spared some of the run-around I've experienced in the past. But this is South Florida, home to more "pill mills" per square mile than just about anywhere else, so it's getting really difficult to even get a legitimate "script filled.

August 01 2011 at 6:40 AM Report abuse rate up rate down Reply
motorbikes

need to check and use in moderation aleve can cause strokes if taken to much. good source of info is Wikipedia

July 31 2011 at 8:40 AM Report abuse rate up rate down Reply
scoval711

No one buys this anymore. I buy Aleve. Much more effective. period

July 31 2011 at 7:19 AM Report abuse rate up rate down Reply
Hi,Duk!

Now, the real reason: This way people will take twice as many pills to get the same affect, thereby doubling the companys sales. They gotta make more money for those billion dollar bonuses.

July 31 2011 at 12:54 AM Report abuse rate up rate down Reply
bumper870

Even American Companies can not Get or do things right.
Plants in Puerto Rico is part of the USA. I believe their Labor force is paid less. What's next a family USA company uses this as an excuse to manufacture over seas. Then it will be Like Bayer once an American Company.
If the Republicans want to Stop the deficit, Bring Jobs Back to the States. If Puerto Rico becomes a states we get two more Senators. Make them a state so they can vote. They can pay taxes the other states pay. and get the benefits other states gets.

http://en.wikipedia.org/wiki/Political_status_of_Puerto_Rico
The Court ruled that Congress can make lower or no Social Security payments to the aged and benefits to children and the poor who reside in unincorporated areas like Puerto Rico, even in the case of an insured who had worked all his life as a resident of the States proper but then moved to live in Puerto Rico.[18] (see Califano v. Torres, 435 U.S. 1 (1978) (per curiam))

July 30 2011 at 5:45 PM Report abuse -1 rate up rate down Reply
1 reply to bumper870's comment
sonyfan13

"Then it will be Like Bayer once an American Company."

FYI, Bayer was never an American company to begin with. It's German, always has been.

July 31 2011 at 2:33 AM Report abuse +1 rate up rate down Reply
dtxnews

Puerto Rico may not be a State but it is a Commonwealth Territory of the USA. That makes its citizens Americans. They serve in our Armed Forces, pay taxes and use American passports. They will also be voting again soon on whether to seek statehood. The things they manufacture add to our GDP and their unemployment rate effects us as any state's would. Oh, and St Thomas, Saint Croix and the other US Virgin Islands are part of America as are American Samoa and several other island groups in the Pacific Ocean. The plants in both Puerto Rico and Pennsylvania have a safety and sanitary problem and so the FDA moved inspectors into the facilities to oversee changes to correct the problems found. And add brand name regular Immodium and Benadryl to the OTC drugs that cannot be found anywhere at the moment.

But geez, take a look at an atlas or google US Territories. This is grade school geography preople!

July 30 2011 at 3:57 PM Report abuse rate up rate down Reply
unikorns60

Switch to something MADE IN AMERICA PEOPLE! (if you can find one) It's shame full that JOHNSON & JOHNSON, a hightly recognized company for other items, took there company to this other country to have foreigners do jobs AMERICANS are supposed to be doing!!! GET AMERICANS JOBS BACK IN AMERICA!!! or DON'T BUY PRODUCTS NOT MADE IN AMERICA! yes, this is ver very difficult, but our children and their children will never have a chance in a Broken Country like America will be, they will have to move to india, or some other foreign country to get jobs, and be paid at only a few dollars an hour like the rest.

July 30 2011 at 2:40 PM Report abuse +1 rate up rate down Reply
Mr. Wonderful

I smell a cover-up! they pulled all of these products off of the shelfs last year including Rolaids at least in calif., Az. and Nev. they actually started disapearing off of the shelfs much eairler the sept. 09. I did read that a congress person was looking into this and made a statement that it appeared the FDA inspectors were getting a little to cozy with the management of this company! and now all three factories that make these products are shutdown, hmmm.

July 30 2011 at 1:50 PM Report abuse +1 rate up rate down Reply
brymelanie

Try Bayer products -may just save your life!

July 30 2011 at 8:58 AM Report abuse rate up rate down Reply