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March 7, 2014

Got a Headache? That Pill Might Kill You

Image courtesy of (Carlos Porto) /

Go to your medicine cabinet or your desk drawer.

Take a peek.

Yep, there it is. That bottle of pain pills that contain ‘regular’ or ‘extra strength’ doses of acetaminophen.

Tylenol, or generic bottles. Hardly a household in America doesn’t have a bottle or six of these pills in them.

But, do you know they can and do kill many people each year, these seemingly innocuous mother’s little helpers?

In a detailed investigation by ‘public interest’ journalism website ProPublica, and a subsequent investigation by Canada’s largest newspaper, The Toronto Star, the very real health risks of misuse or overuse of acetaminophen were outlined.

Who knew? Certainly not the majority of truckers, shift workers, party hounds and pretty much anyone else who reaches repeatedly for the trusty bottle of Tylenol or other brand name acetaminophen products whenever they have a headache or muscle ache?

If you’re gobbling Tylenol or other acetaminophen tablets by the fistful — and man, many of us are — you’re headed down a bad road, warns the Federal Food and Drug Administration (FDA).

Last month, the FDA issued a statement that combination prescription pain relievers that contain more than 325 mg of acetaminophen per tablet, capsule, or other dosage unit should no longer be prescribed because of a risk of liver damage. Cases of severe liver injury have been reported in patients who took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period, took two or more acetaminophen-containing products simultaneously, or combined alcohol with acetaminophen products.

Paracetamol toxicity is caused by excessive use or overdose of the analgesic drug paracetamol (known by the generic name acetaminophen in North America). Mainly causing liver injury, paracetamol toxicity is one of the most common causes of poisoning worldwide. In the United States and the United Kingdom it is the most common cause of acute liver failure.

Many individuals with paracetamol toxicity may have no symptoms at all in the first 24 hours following overdose. Others may initially have nonspecific complaints such as vague abdominal pain and nausea. With progressive disease, signs of liver failure may develop; these include low blood sugar, low blood pH, easy bleeding, and hepatic encephalopathy. Some will spontaneously resolve, although untreated cases may result in death.

Damage to the liver, or hepatotoxicity, results not from paracetamol itself, but from one of its metabolites, known as NAPQI, which depletes the liver’s natural antioxidant glutathione and directly damages cells in the liver, leading to liver failure. Risk factors for toxicity include excessive chronic alcohol intake, fasting or anorexia nervosa, and the use of certain drugs such as isoniazid.
 The Internet physician information site Medscape alerted physicians to be aware the FDA “also recommends that pharmacists contact prescribers to discuss an alternative when they receive a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit.”

The FDA, last year, published a white paper that was aimed at making “it easier for consumers to: 1. Identify that their prescription pain reliever contains acetaminophen, 2. Compare active ingredients on their prescription and over-the-counter labels, and 3. Take action to avoid taking two medicines with acetaminophen.”

The FDA recommends, at the least, the following actions to help anyone who takes OTC or prescribed pain medication, be aware of and reduce the risks of toxic liver damage from overuse of acetaminophen:

• Complete spelling of acetaminophen and all other active ingredients on the pharmacy labels of all acetaminophen-containing prescription medicine, eliminating the use of abbreviations, acronyms or other shortened versions for active ingredients.

• A standardized concomitant use and liver pharmacy warning label for these medicines.

• Formatting and wording on pharmacy container labels consistent with plain language and health literacy principles.

• A stakeholder call to action: adopt, implement, adhere, communicate and educate.

For more on the FDA’s findings, click here.

A troubling question emerges as more information and reportage emerges on the toxicity risks of acetaminophen: Where have the drug manufacturers been on the topic of this subject? Where have the warnings been in commercials on television? You know the kind that takes up the last half of most ads for heart and erectile dysfunction medications? “Side effects may include….” everything from a four-hour erection to anal leakage.

Not hearing that from the big pharma producers of these products, almost considered harmless magic jelly beans by most of us when it comes to curing a headache or sore knee.
 It appears these pills have the capability of laying low troubling numbers of our unsuspecting population, but we’re only hearing about its potential toxicity now. 
Folks, the drug companies have been making acetaminophen since 1947.

And it isn’t just OTC drugs that are coming under closer scrutiny. The ProPublica investigations also found the largest national advocacy group for pain sufferers in America had board members and doctors on staff who had close, if not conflict-of-interest-close, ties to big pharma.

Ask anyone in the field of treatment of pain medication addiction and they’ll tell you there’s a pandemic in North America caused by haphazard and over-prescription of opioid pain medications.

Are the doctors blissfully unaware or they financially wedded to prescribing these types of addictive medications? There are dozens of arguments for both sides of that picture, but there’s a troubling connection coming to light between many large advocacy agencies and the drug companies — between the medical ‘experts’ on these panels and bodies and big pharma.

In stories this year, ProPublica has detailed the close entanglements between pharmaceutical companies and groups representing doctors. Reporting showed that the positions of societies representing specialty physicians often reflected the views of their major funders.

The American Pain Foundation falls into a different category — health advocacy. It harnesses the power of patient stories to sway politicians, state medical boards, judges and government health regulators, emphasizing that it represents grassroots voices.

ProPublica’s review found that the foundation’s guides for patients, journalists and policymakers play down the risks associated with opioids and exaggerate their benefits. Some of the foundation’s materials on the drugs include statements that are misleading or based on scant or disputed research.

The Center for Disease Control and Prevention has some startling figures on the absolute nightmare of prescription painkiller misuse — remember, many of those include doses of acetaminophen in the mix of the opioids and others: “In a period of nine months, a tiny Kentucky county of fewer than 12,000 people sees a 53-year-old mother, her 35-year-old son, and seven others die by overdosing on pain medications obtained from pain clinics in Florida. In Utah, a 13-year-old fatally overdoses on oxycodone pills taken from a friend’s grandmother. A 20-year-old Boston man dies from an overdose of methadone, only a year after his friend also died from a prescription drug overdose. These are not isolated events. Drug overdose death rates in the United States have more than tripled since 1990 and have never been higher. In 2008, more than 36,000 people died from drug overdoses, and most of these deaths were caused by prescription drugs.”

If you know a family doc, chances are he or she are not ever going to acknowledge the creeping influence of big pharma on their practices. They’re almost to a man or woman going to absolutely deny there are any connections to pharmaceutical firms influencing or benefiting their practice in any tangible way.
 But, it would positively make your non-medical head spin to read the Machiavellian tentacles that big pharma has inserted in the family practitioner’s constant duty to remain up to date on treatment regimens.

In an article that delves into that reach, Whole Health Chicago spells out just how much big pharma provides to the online resources for physicians to remain current and up to standards with their state medical boards.

The entire article is enlightening and frightening at the same time: My point here isn’t mean to be construed as an attack on your family doc or big pharma, entirely, although both bear some responsibility for the stunning lack of knowledge among the population that blindly gobbles medications prescribed by the former and pumped out by the millions by the latter.

No, it’s to warn that we all must pay more attention to what we’re stocking on our medicine cabinet shelves, the drugs we’re giving ourselves, our children and our elders and the effects they have on our health.

Clearly, as we’ve seen, the medical community and the pharmaceutical companies haven’t been doing their jobs in that regard.


Chris Malette is a retired newspaper journalist with 35 years of experience as a reporter and city editor. Over his career, Malette covered municipal and federal politics, military, health and court beats. He has reported from Somalia, Bosnia, Haiti and covered relief efforts in Honduras in the wake of Hurricane Mitch in 1998. He now works for SPN News as an editorial columnist.