NyQuil Survives Nanny State Police, For Now

It was touch and go for NyQuil’s manufacturer, Procter & Gamble, yesterday while a panel of experts met to decide its fate.  The panel was considering whether to recommend the Food and Drug Administration (FDA) pull the popular, over-the-counter cold medicine from the market because a relatively small number of consumers ingest too much of the product which contains the pain medicine, acetaminophen.  Overdoses of acetaminophen can cause liver failure in some persons (an estimated 458 fatal cases per year in the U.S. in the 1990s), and the FDA has been considering further limits on drugs, both prescription and over-the-counter, that contain this widely popular and highly effective pain medicine.

In typical nanny-state fashion, the FDA-empaneled experts were voting on whether the fact that .0000015 percent of the consuming public suffered fatal liver failure possibly related to acetaminophen overdoses, should justify inconveniencing the entire population of Americans that use popular and effective cold medicines.  

While NyQuil survived this latest attack of the nanny state, the experts did recommend changing the doseage limits for acetaminophen products, and banning certain prescription medicines that combine that substance with other pain medicines.  The FDA usually follows the advice of its empanelled experts.

The FDA of late has been flexing its regulatory muscles, even going so far last May as to accuse General Mills of violating federal drug labeling laws because boxes of its Cheerios product advertised the cereal might help reduce cholesterol.  Just last month, President Barack Obama signed legislation into law that gave the FDA power to regulate tobacco products.  

NyQuil may have dodged a fatal bullet this time, but with a newly energized FDA, now headed by a zealous, former New York City Health Commissioner (Margaret Hamburg), Procter & Gamble, General Mills, and every other company that manufactures an ingestible or inhaleable product had better gird for a long series of battles over at least the next three-and-one-half years.

38 comments Add your comment

Jen

July 1st, 2009
7:47 am

Uhhhh….I’ve worked in the pharmaceutical industry, Bob. Be very glad for the FDA. The industry would never protect you, even in a true market-based economy. There would never be motivated to. A drug would have to harm or kill more than 5% of the population before they’d budge. And, Bob, 5% is scarily large.

Lee

July 1st, 2009
7:59 am

What I want to know is, how much NyQuil would you have to ingest to suffer liver damage? My guess, these folks were drinking the stuff like water. Not to mention, they were probably taking other medications that contained acetaminophine (such as Tylenol) at the same time.

Or, as comedian Ron White would say, “You can’t fix stupid.”

jt

July 1st, 2009
8:00 am

I bleed the blocks, not with the rocks, I bleed with the candy paint
Sippin’ promethazine codeine with a jolly rancher with a dandy drink.

To rely on ANY federal goverment mafia agency to protect you is STOOPID.

Jen

July 1st, 2009
8:04 am

Not to mention you’re a liar, Bob. This ruling largely affects the PRESCRIPTION Nyquil…not over the counter Nyquil.

M@

July 1st, 2009
8:39 am

When did Barr say get rid of the FDA?

Links Jen?

Dr Hibbert

July 1st, 2009
9:06 am

Perhaps the wise sages at the FDA would be better advised to try and ensure the public is not
poisoned by future ‘approvals’ for drugs such as Celebrex or numerous other ‘miracle cures’ that
they have turned a blind eye to in recent years, rather than try and micromanage the general
public. But then, if people are too worried about having useful pain medications taken away,
I am sure the FDA won’t have any problem with those individuals buying a carton of cigarettes
and a bottle of scotch.

[...] NyQuil survives the nanny state police — for now, says Bob Barr. [...]

Copyleft

July 1st, 2009
9:37 am

I get it now. Barr isn’t going with actual libertarian issues… he’s just seizing on pop-infotainment stories with catchy taglines!

What a disappointment. As has already been noted, the TRUTH behind this story refers to prescription-strength Nyquil. But the truth would get in the way of firing up the old outrage engine.

This column is no better than talk radio. How sad.

The REAL GodHatesTrash, Superstar

July 1st, 2009
10:04 am

Fat southerners a real public health problem… Outlaw Cheetos and porkrinds!

Mississippi’s still fattest but Alabama closing in

BY LAURAN NEERGAARD
AP Medical Writer

WASHINGTON (AP) — Mississippi’s still king of cellulite, but an ominous tide is rolling toward the Medicare doctors in neighboring Alabama: obese baby boomers.

It’s time for the nation’s annual obesity rankings and, outside of fairly lean Colorado, there’s little good news. Obesity rates among adults rose in 23 states over the past year and didn’t decline anywhere, says a new report from the Trust for America’s Health and the Robert Wood Johnson Foundation.

And while the nation has long been bracing for a surge in Medicare as the boomers start turning 65, the new report makes clear that fat, not just age, will fuel much of those bills. In every state, the rate of obesity is higher among 55- to 64-year-olds – the oldest boomers – than among today’s 65-and-beyond.

That translates into a coming jump of obese Medicare patients that ranges from 5.2 percent in New York to a high of 16.3 percent in Alabama, the report concluded. In Alabama, nearly 39 percent of the oldest boomers are obese.

Health economists once made the harsh financial calculation that the obese would save money by dying sooner, notes Jeff Levi, executive director of the Trust, a nonprofit public health group. But more recent research instead suggests they live nearly as long but are much sicker for longer, requiring such costly interventions as knee replacements and diabetes care and dialysis. Studies show Medicare spends anywhere from $1,400 to $6,000 more annually on health care for an obese senior than for the non-obese.

The REAL GodHatesTrash, Superstar

July 1st, 2009
10:08 am

Georgia ranks 14th in piggishness.

Outlaw Ceci’s Pizza, and other dens of outrageous gluttony.

Crack dealers to the fat and stupid.

The REAL GodHatesTrash, Superstar

July 1st, 2009
10:16 am

Georgia wins the “Fat Kid” Bronze Medal, though:

Mississippi also had the highest rate of overweight and obese children, at 44.4 percent. It’s followed by Arkansas, 37.5 percent; and Georgia, 37.3 percent.

reebok

July 1st, 2009
12:10 pm

Bob Barr is not a liar. He is simply misinformed as always. Besides, the truth is frequently boring and doesn’t cause nearly as much outrage.

Later today, Hannity, Boortz and the other shrieking wingnuts can cite Bob Barr as their source and gets hours of frothing-at-the-mouth phone calls from their listeners. It’s a good system.

j0n

July 1st, 2009
12:44 pm

we need massive education campaigns to encourage people to be healthy and active and to eat well and not abuse drugs. we do NOT need big government making laws regarding what citizens can and cannot put into their bodies. if a person is stupid enough to take acetaminophen without researching the drug and its consequences, such is still not an invitation for big government to intervene.

[...] A SMALL VICTORY: NyQuil Survives Nanny State Police, For Now. [...]

Tom Hill

July 1st, 2009
1:18 pm

I’m looking for a link on prescription NyQuil because I’d never heard of it. The other drugs that were recommended for ‘banning’ were prescription strength, but a quick internet search has come up empty for prescription NyQuil.

Chris Wysocki

July 1st, 2009
1:22 pm

“Prescription Nyquil”? Excuse me, but the Nyquil that actually does some good doesn’t require a prescription, it requires you to show photo ID, sign a log book, and limits how much you can purchase in a 90 day period thanks to Joe Biden’s war on Rave Music. A meth lab once bought a truckload of the stuff so the nanny staters made it a “controlled substance” and regulated it. The FDA’s latest action is yet another instance of how they inconvenience millions of Americans just to prevent a few people from doing something wrong.

Trouble

July 1st, 2009
1:27 pm

There is no prescription NyQuil. All versions of the product are OTC.
Source: Drug Facts and Comparisons, copyright 2009, Wolters Kluwer Health.

Once again, the FDA is pursuing wild waterfowl. Nice try liberals, show work next time.

Dana H.

July 1st, 2009
1:29 pm

Jen wrote: “Be very glad for the FDA. The industry would never protect you, even in a true market-based economy. They would never be motivated to.”

This claim is preposterous. The threat of billion-dollar liability lawsuits, which the industry faces even under the FDA, is a huge incentive to make sure their products are safe. The FDA has stifled medical innovation and caused great suffering and death thanks to delays in approval and restrictions it imposes on the use of pharmaceutical products. Even though Bob Barr is not arguing the position you ascribe to him, we would indeed be better off without the FDA.

There’s a good article here on “Drug Safety vs. the FDA”: http://www.aynrand.org/site/News2?page=NewsArticle&id=10859&news_iv_ctrl=1021

ConservaDad

July 1st, 2009
1:48 pm

“The panel was considering whether to recommend the Food and Drug Administration (FDA) pull the popular, over-the-counter cold medicine…”

There is no prescirtion NyQuil.

“n typical nanny-state fashion, the FDA-empaneled experts were voting on whether the fact that .0000015 percent of the consuming public suffered fatal liver failure possibly related to acetaminophen overdoses…”

This represents 15 cases of liver failure in every 10,000,000 people AND they are only “possibly” related to acetaminophen overdoses. Don’t know where Jen came up with 5%. What’s next, the Nanny State toilet paper police who will decide about the roughness quotient of different brands…Cheryl Crowe should apply, wouldn’t matter how rough it is if you only use 2 squares like she says.

Mike Foster

July 1st, 2009
1:48 pm

I’d lay 100:1 “Jen” never stepped foot in a pharmaceutical facility. And even if she did, what, she was in the board meetings where the evil white guys cackled and chuckled about how they were perfectly fine with killing 4% of the users of their products, but 5% was unacceptable? Truly laughable. I love appeals to authority from largely anonymous posters…

[...] by stories that need real questions, like how cap n trade actually passed the house, whether the WH really needs to guard us from ourselves and Nyquil, and um…what the hardest-working man in show business thinks about reports of dissenters [...]

Jay

July 1st, 2009
1:58 pm

Contra Jen, Copyleft, and reebok, Mr Barr is fairly accurate. The FDA panel did vote on NyQuil and Theraflu, both non-prescription medications, but voted not to restrict them. That’s what Barr said.

Additionally, the panel did vote to restrict several other non-prescription forms of acetaminophen: by a 21-16 vote, they recommended lowering the max. daily dose of nonprescription acetaminophen. The panel recommended 24-13 that the max single dosage should be lowered to 0.65g or 35% less than Extra Strength Tylenol’s recommended dosage for people 12 and up. They voted 26-11 to make 1g dosage available only by prescription.

The complaint against Barr should be that he sidesteps the 56k ER visits because of acetaminophen. That is a problem. His would likely respond that much of proposals are fig-leaf remedies. Fine, the FDA may ban Vicodin and Percocet (not an unalloyed good given that some people are in chronic pain). But the proposed restrictions on non-prescription acetaminophen cannot stop a person from just taking more pills–three to four 325mg tabs instead of two 500mg–and that is a serious objection. Not every problem can be solved.

Moira

July 1st, 2009
2:13 pm

I am horrified at this ruling. They are attempting to ban drugs like Percocet and Vicodin. There is nothing else that helps after a rough, tons-of-stitches childbirth experience except Percocet. Some high handed bureaucrats from the FDA would step between my doctor and me and decide “it’s not safe”. What’s next? No epidurals? “Cause you don’t really NEED them you know.” Stupid politicians. Morphine doesn’t work for me. Aspirin’s out when you’re breastfeeding. Now I’m going to have nothing, not even while I’m in the hospital. Boy THANKS, GUYS. Way to discriminate against childbearing women. This is disgusting. Someone has to stop these despots before they outlaw all pain medication entirely.

SB

July 1st, 2009
2:23 pm

If human life is the measure, let’s instead severely lower the max daily dosages of power lust in both the legislative & executive branches of the federal government. Far more people have died as a result of the weilding of political power than anything done by business & industry.

Darren

July 1st, 2009
2:26 pm

The commenters are conflating NyQuil, which is the OTC medicine discussed in the article, and other prescription medicines like Vicodin, or its generic version, hydrocodone/APAP. There is no “prescription strength” version of NyQuil.

The problem is that acetaminophen is actually very toxic to the liver if taken in doses beyond the recommended levels, or with other common substances like alcohol. For a normal person, taking 10,000mg of acetaminophen will put you in liver failure, assuming you eat enough Tylenol and then don’t tell anyone for a few days. Lower doses (4,000mg/d) over multiple days can also be dangerous. People with reduced liver function due to a variety of causes (alcoholism, chronic hepatitis, acute hepatitis, etc.) can overdose on acetaminophen at even lower doses, which is the chief cause of concern — a select population that really shouldn’t be taking anything with acetaminophen in it.

A lot of acetaminophen-related visits are for children, there was a story several years ago about a child overdosed on acetaminophen because the parents gave them infant Tylenol (highly concentrated) at the child Tylenol dosage, inadvertantly overdosing their child. There isn’t a dialysis option for the liver, once it’s gone it’s transplant or death.

And BTW, Celebrex is still on the market, and it works very well. Vioxx, in the same class but not the same drug, was recalled. The FDA approved all these drugs, it was only post-approval surveillance that found the problems with COX-2 inhibitors in some patients, and in other drugs like fenfluramine, Baycol, and others. You can’t make enough money on a drug to undo the bad publicity and decades of litigation that follow something like a Vioxx recall. The idea that a company would willingly ship a drug that will kill 5% of the people who take it is idiotic, and something the FDA would never approve in the first place.

Darren

July 1st, 2009
2:30 pm

Moira, you will still be able to get the opiate in Vicodin and Percocet, just not in a pill mixed with acetaminophen. Acetamiophen, for most people, isn’t really an anti-inflammatory and is only a marginal pain reliever compared to other NSAIDs like aspirin, ibuprofen or naprosyn. The difference is that you can take acetaminophen without messing up your stomach, a risk with all NSAIDs except Celebrex.

If you insist you can take a regular-strength Tylenol along with the nerfed, acetaminophen-free Vicodin, but I believe you’ll find the hydrocodone alone will relieve the pain you’re concerned about.

Rex

July 1st, 2009
3:18 pm

As I understand it, Vicodin has acetaminophen added so as to put a safety limit on the total number of pills you can have in a 24 hour period. The magic number for acetaminophen is no more than 4,000 mg per day. If it weren’t for the acetaminophen added to Vicodin, there wouldn’t be the limit on the hydrocodone part of Vicodin that there is, but I don’t know what the limit for pure hydrocodone is.

The REAL GodHatesTrash, Superstar

July 1st, 2009
3:56 pm

Fat folks have fatty livers, and fatty livers can’t process acetaminophen as well as normal ones.

Obesity is almost as hard on your liver as alcoholism.

Perhaps just ban the sale of Nyquil in Dixie.

StJ

July 1st, 2009
4:11 pm

They considered banning Nyquil because 0.0000015 percent of the consuming public suffered fatal liver failure “possibly related” to acetaminophen overdoses when the user was ALSO combining it with other drugs that contained acetaminophen? Seriously?
OK, that’s it, time for a complete automobile ban. Some stupid fool might mix driving with the use of cell phones and kill somebody. Oh, wait, they’re doing it already, and at a much higher percentage!!
Moral of the story: You can’t protect the stupid from themselves. I think this is called the “law of natural selection”.

GOP is gone

July 1st, 2009
7:56 pm

The problem lies with the public not reading labels. Many people combine medications which all have acetaminophen without their knowledge. They take Nyquil without realizing it contains tylenol, and then take tylenol thinking they have “aches” and it will help. A campaign to make the consumer more knowledgeable would probably suffice. By the way Vicodan contains extra strength tylenol, 500mg per tablet, where Percocet contains regular strength tylenol, 350mg per tablet. I have often found that patients who take ½ tablet of say Percocet or Vicodan along with a plain tylenol, it is adequate for pain relief. I usually recommend it to cut down on the addictive opiate in the Vicodan and Percocet prescriptions.

links for 2009-07-01

July 1st, 2009
10:00 pm

[...] NyQuil Survives Nanny State Police, For Now In typical nanny-state fashion, the FDA-empaneled experts were voting on whether the fact that .0000015 percent of the consuming public suffered fatal liver failure possibly related to acetaminophen overdoses, should justify inconveniencing the entire population of Americans that use popular and effective cold medicines. (tags: medicine government politics idiocy) Posted in del.icio.us « links for 2009-06-27 [...]

Esther Taylor

July 2nd, 2009
12:18 am

Let’s see: Jen has called Barr a liar. Not just mistaken, but a liar. She did so based on a claim that seem to have been refuted. It seems to me that she should either back up her original claim or do the honorable thing and apologize.

I wonder what the FDA recommends as the safe limit for holding one’s breath.

Paul

July 2nd, 2009
10:27 am

Jen claims that in a free market that the drug companies would be fine with a 5% mortality rate. Tell that to J&J during the 1982 Tylenol tampering case. They lost a huge amount of marketshare because 7 people died and the public thought it might be related to their product. Drug companies pay attention to drug mortality, just as the public does.

Happy

July 2nd, 2009
2:21 pm

In celebration of our nations birthday…on my way home I will visit the local grocery store, purchase 5 bottles of Nyquil, drink them all and all weekend party like its 1999!!!

Yea baby…lets abuse some drugs!!!

Diorist

July 3rd, 2009
1:34 pm

It’s probably just as well. Nyquil has been a sad shadow shadow of its former self since the ’90s. I don’t know what they did to it, but the sniffling-sneezing-coughing-aching-why-did-i-wake-up-on-the-kitchen-floor medicine is definitely no more. I’m just glad I’m old enough to remember it.

Steynian 370 « Free Canuckistan!

July 3rd, 2009
7:53 pm

[...] OVERTHECOUNTER COPS? NyQuil Survives Nanny State Police, For Now …. [...]

David S

July 4th, 2009
10:42 am

If anything, people should not be buying Nyquil because Proctor and Gamble continues to kill nearly 50,000 innocent animals every year in unnecessary and unrequired “safety” tests. These tests in many cases are not required by the FDA or in most cases, there are fully equivalent non-animal tests that can identify safety concerns.

While virtually all of their competitors have responded to public pressure and ongoing boycotts of their products, the murderers at P&G seem to take great pride in all of the unnecessary animal deaths that they cause.

Only through the public exercising their most powerful perogative – their consumer choice, will P&G ever get the message that killing animals for no reason is wrong.

As for our safety, the FDA must be dismantled and a system of private certification organizations be allowed to fill its place. Nobody ever questions the actions of UL, TUV, CSA, or Consumer Reports, but the public gets completely reliable safety assurance and quality reporting from them without the force and incompetence that accompany all government oversight agencies.

Tens of thousands die every year because critical drugs are kept off the market, while thousands of others die from products that were given “approval” likely due more to political reasons than actual data supporting safety.

Believing that utopia comes with every government intervention should be cleary seen by now to be a false and reckless belief. The free market may also not be utopia, but the competition, threat of liability, and the inherent freedom to choose other products will provide a far greater measure of safety than the current politically manipulated system of big business protectionism and fundamental lack of choice and competition.

Michael H. Smith

July 4th, 2009
3:32 pm

As for our safety, the FDA must be dismantled and a system of private certification organizations be allowed to fill its place.

If drug manufactures were blind to this system of private certification organizations so they could never know exactly which private company is doing the testing of their particular drug until after the results were made known that would unquestionably be the best possible remedy.