Tylenol, NyQuil Face FDA Scrutiny

Experts to Vote on Whether Acetaminophen Overdoses Merit Pulling Popular Meds Off Shelves

(AP)  Government experts are scheduled to vote on whether Nyquil and other combination cold medications should be pulled from the market to help curb deadly overdoses.

The Food and Drug Administration has assembled more than 35 experts for a two-day meeting to discuss and vote on ways to prevent overdose with acetaminophen, also known as paracetamol - the pain-relieving, fever-reducing ingredient in Tylenol and dozens of other prescription and over-the-counter medications.

Despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., sending 56,000 people to the emergency room annually, according to the FDA. There are about 200 acetaminophen-related deaths each year.

"It can happen to anybody, but it's very rare," said Dr. Lee Simon, an associate professor at Harvard Medical School, who attended Monday's meeting. "Obviously it's important that we improve the communication about these products because they are ubiquitous, and we still see people inadvertently overdosing."

The drugs that could be pulled off shelves are combination medications, such as Procter & Gamble's NyQuil or Novartis' Theraflu, which mix acetaminophen with other ingredients that treat cough and runny nose.

The FDA is not required to follow the advice of its panels, though it usually does. The panel vote is scheduled for Tuesday afternoon.

Manufacturers could lose hundreds of millions of dollars in sales if combination drugs are pulled from the market. Total sales of all acetaminophen drugs reached $2.6 billion last year, with 80 percent of the market comprised of over-the-counter products.

The FDA says patients often pair the cold medications with pure acetaminophen drugs, like Tylenol, exposing themselves to unsafe levels of the drug.

But the industry group that represents Johnson & Johnson, Advil-maker Wyeth and other companies defended the products Monday, saying they pose a relatively small risk to patients.

Only 10 percent of deaths linked to acetaminophen medications involved over-the-counter combination cold medications, according to the Consumer Healthcare Products Association.

The majority of deaths were caused by either single-ingredient drugs or prescription strength combination drugs like Endo Pharmaceutical's Percocet, which combines oxycodone and acetaminophen.

"We believe there is a clear health benefit of over-the-counter combination products containing acetaminophen," said Linda Suydam, the group's president.

Tylenol-maker Johnson & Johnson also pushed back against a proposal to lower the maximum daily dose of acetaminophen, which is currently 4 grams daily, or eight pills of a medication like Extra Strength Tylenol.

While taking more than 4 grams per day can cause liver injury, J&J argued that taking the exact dose is proven to treat osteoarthritis pain.

The FDA panel also will vote on a series of other proposals, including changes to the packaging and labeling of medications. Both ideas are designed to prevent patients from taking more than the recommended dose of the drug.

[coonberry]

What about people in our country that can not take aspririn or ibuprofen? They are left only to take acetaminophen (tylenol) based products. When you have injures that you have to take a strong perscription medicine but your trying to band the only source of pain relief for us. I was One year old when baby aspirin amost killed me. I have never been able to take any asprinin or ibuprofen products because I will go into shock and die. I am 48 years now and have always had to take acetaminophen products. Taking away these products is like killing us. How much pain can one endure? People are idiots that does not read labels and warning signs, but because we live with these idiots the government would take away the only sources I and others have to control pain.

[bobnjersey]

["It can happen to anybody, but it's very rare," said Dr. Lee Simon, an associate professor at Harvard Medical School, who attended Monday's meeting. "Obviously it's important that we improve the communication about these products because they are ubiquitous, and we still see people inadvertently overdosing." ]

that's what the process of natural selection is all about ... the idiots should be rewarded with extinction.

[aChangeOfIdeas]

Only 10% of the ODs were from OTCs... so 5600. Not enough to convince me to start pulling products off the shelf, especially when the problem is with the consumer. Better labeling, make scary warnings, that's all it needs.
And of the 56000, what's the breakdown of ages? I wonder how many are elderly and perhaps have memory issues so they take more medicine than they are supposed to, can't read the small warning labels without going back upstairs to find their glasses... can't metabolize the drug as well as younger folks anyway...
It's also funny how you can't please everyone. The multitudes cry out when a couple people die from a heart medicine or the like and want the company to pay, but 56000 people are injured by acetominophen and the govt is "trying to control us". No, they're trying to protect you... although maybe too much.

[anti-global2]

This is just an attempt to make sure people need to go to the doctor more often, therefore running up more medical bills and therefore becoming more desperate and supporting govt' run health coverage.
Think about it, your sick, 9 times out of 10 you go to the store and buy over the counter medications to get you through. Now you won't have that option, you can either visit a doctor every time you sneeze, or wait it out and pray you don't end up with a severe illness.
Obama needs to stop using backdoor methods to get legislation passed, and stop manipulating the system to benifit certain groups, doctors, choice banks, General Electric ect.
Man I'm really sorry I voted for Obama, I won't make that mistake twice. he'll be out in 2012 and then someone can un-do anything he managed to get passed. Even if he manages to get universal healthcare through executive order (it won't pass the Senate) it will only last a few years, it will be overturned and nullified by the next President.

[John_Merritt]

The common rule of thumb is: anything taken to excess will cause harm to you. Anybody overdosing on Tylenol is not trying to kill themselves, it is more a cry of help than anything else. Do you realize how much needs to be taken (except for babies and infants) by an adult to trip the lights fantastic? Really people. The FDA is busy trying to regulate the things they need to, don;t have enough people, don't have enough time, and don't have enough money to do the job they are supposed to right now. Buyer beware: If you are stupid enough to try and get high, or trying to get low; be real careful. Put a label that says 'HEY STUPID: Read the directions carefully'.

[lizannrand]

Just another way the government is trying to gain control. What about those of us who need the medication and we use it properly? Why should everyone be punished because some people go overboard and use things (all things) not in the way they were meant to? OTC meds should be a choice (and yes they should have warnings), just like cigarettes, and alcohol. Unreal. What is the government going to try to control next? The type of sanitary products we use? UGH. I really hope the world is in Revelations. Something needs to change.

[jasperlily]

' acetaminophen remains the leading cause of liver failure in the U.S., sending 56,000 people to the emergency room annually, according to the FDA. There are about 200 acetaminophen-related deaths each year."

"It can happen to anybody, but it's very rare," said Dr. Lee Simon, an associate professor at Harvard Medical School, "

Huh?

[ianlou]

Aspirin really is a wonder drug.
Works Great, costs next to nothing, and never lands in stories like this one.

[gramto8]

Oh, really? ASA (Aspirin) can just thin your blood so that you will bleed to death in case of a severe injury or in case the aspirin causes a gastric ulcer that perforates.

[mutnauq4842]

by gramto8 June 30, 2009 6:44 AM PDT
_________________________________________________________________________
Aspirin "thins" the blood? Would you be kind enough to Google the mechanism for this "thinning" process?

Better yet, could let me know where in the coagulation cascade aspirin
has its effects? And while you're at it would you help me to understand the relationship of PT to INR? You being the great medical expert that you are, it should be no problem.

M

[justfacts2]

Why punish the general public because some idiots don't have any self control! The drugs aren't the problem its these teenagers, and others, looking for a high just to forget their problems. Here's a newsflash for all of you addicts out there - there is something better out there that will help you forget all of your problems/issues and it is something called THERAPY!

[formrusmcsgt]

I don't think the label has a warning sign that the medications can cause liver damage even if used correctly.

by andie52 June 30, 2009 5:16 AM PDT

"Obviously it's important that we improve the communication about these products because they are ubiquitous, and we still see people inadvertently overdosing."

Read the article. we're not talking about people dying from two caps. It's about morons who can't follow somple dosing instructions.

[hologram5]

How's this for the dumbing down of a society, eh?

Because thousands are now so moronic that they can't read a simple label, we'll have to go by the pharmacy for a pre-packaged pair of capsules when we have a headache.

Sheesh.

Dumbing down of society? Let's talk about flouride and chlorine. Both have known properties of shorting out synapses in brain transmissions. Nobody talks about that though. And everyone drinks the water every day...

[hologram5]

FDA, what a joke. These people are puppets to the Big Pharma. They have been bought off years ago. Come on, really?

[formrusmcsgt]

Despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., sending 56,000 people to the emergency room annually, according to the FDA. There are about 200 acetaminophen-related deaths each year.
-----
How's this for the dumbing down of a society, eh?

Because thousands are now so moronic that they can't read a simple label, we'll have to go by the pharmacy for a pre-packaged pair of capsules when we have a headache.

Sheesh.

[andie52]

I don't think the label has a warning sign that the medications can cause liver damage even if used correctly.

[jtdev1]

Acetaminophen is found in nearly all prescription pain killers along with cold medicines, etc... You can't buy a product that doesn't contain it.

So you take the pills your doctor prescribed along with that cold medicine and you have a headache... There you go, you've overdosed without ever knowing how much acetaminophen you've taken.

Same thing wiht HFCS. It's in everything. Again, it's fine in moderation, but when you add up all the crap you've eaten that has it in there, again, you've overdosed...

[gramto8]

Acetaminophen is found in SOME prescription pain killers as well as most cold medicines. If it is in a Rx pain med, the name usually ends in 'et' (Darvocet) or has the initials 'APAP' (Hydrocodone/APAP) as part of the name. In the paperwork that accompanies your Rx meds, the information regarding acetaminophen will be listed. READ IT!! They don't print it just to waste paper. It is printed to prevent Tylenol overdoses!

[mutnauq4842]

by gramto8 June 30, 2009 6:19 AM PDT
In the paperwork that accompanies your Rx meds, the information regarding acetaminophen will be listed. READ IT!! They don't print it just to waste paper. It is printed to prevent Tylenol overdoses!
_______________________________________________________________________

Gee, silly me. I was led to believe the PPIs or patient package inserts gave information regarding the type of medication, its indications, proper utilization, potential interactions and adverse effects...It is in with your prescription because the FDA requires it. But really, as some of the information may be a little tricky in the PPIs, the pharmacist the preferred source of counseling regarding correct utilization of your RX medication-You know, usually the guy with the PharmD after his name. Would you happen to have a PharmD after your name?