common OTC drug, narrow “safety margin”

The U.S. Food and Drug Administration (FDA) will be considering later this month, at a meeting in Maryland, new restrictions on the labeling and strength of the pain-reliever acetaminophen (known internationally as paracetamol; the most famous brand is Tylenol). Studies show most consumers are unaware of the risks of the drug. It is not a bad medication—it can be a wonderful alternative to aspirin—but you need to be extra cautious with its use…let’s discuss why.tylenolbottle

Drugs can be classified as to their “safety margin”, which refers to a comparison of the dose of a drug needed to be therapeutically effective compared with the amount of the drug needed to produce toxicity. Some drugs, for example, penicillin, are considered to have a rather wide safety margin because a relatively small dose of these drugs can be therapeutically effective (here, cure an infection), but normally you need a very large dose to get serious toxicity.

On the other side of the safety margin scale are drugs like acetaminophen, which have a NARROW margin of safety, meaning, the difference between a normal therapeutic dose and a dose that will produce toxicity or even death is relatively small (“narrow”).  So you need to be extra careful when taking a drug with a narrow safety margin, like Tylenol. Overdosage is common, and serious Tylenol overdosages are NOT easy to treat or reverse. Sometimes the only treatment is a liver transplant. Milder overdoses that occur over a period of time might not even be recognized by the patient, but result in chronic liver damage.paracetamol

Shockingly, acetaminophen overdosage is the “leading cause of acute liver failure in the United States”. Meaning this drug is worse than alcohol for causing acute liver failure (note that “acute” in a medical sense does not mean serious, rather, acute means a condition that arises or appears over a very short period of time).

Severe liver damage from this OTC drug can occur from a dose that you might not consider excessive. A person who already has some level of liver problem—for example from chronically drinking too much alcohol—can suffer irreparable liver damage from taking only four or five 500 mg. tablets over one 24 hour period.

Currently, the maximum safe dose (as listed on the product label) is 4000 milligrams per day, meaning: a maximum of two-500 mg. “extra-strength” tablets every 6 hours for a day. But…how often do you think this dose is exceeded, if not by you, by others in pain who, rather than wait 6 hours between doses, take a new dose after only, say, 4 hours? It’s happens a lot.

So at the FDA meeting later this month, the group will consider a recommendation to lower the maximum daily dose from 4000 mg. to 2600 mg., and cut the size of the biggest allowable tablet from 500 mg. to 325 mg. No matter what they decide, take caution with this drug, especially if you already have any liver disease, have elevated “liver enzyme” blood levels, take statin drugs to lower cholesterol, or you drink a moderate or greater amount of alcohol daily. It’s not clear at what level of daily alcohol use you have to be concerned; the Tylenol label says to “ask your doctor if you drink more than 3 drinks per day”, but many experts believe if you drink less than that you should be extra careful with acetaminophen.

Your physician should be able to answer any questions about your liver function with some simple blood tests, and if you have concerns about your daily alcohol intake combined with acetaminophen.  For everyone however, even those who drink rarely, if you “binge”—drink significant alcohol at any one time—don’t use acetaminophen to try to treat a headache or hangover (however aspirin is not great either, because it can irritate the stomach).

Be aware that acetaminophen (or paracetamol or APAP as it is known in some countries), is not only found in the Tylenol brand, but is a component of many other common OTC medications… over 200 formulations contain acetaminophen but don’t carry the Tylenol label, and the presence of acetaminophen is only discovered by reading the fine print on the back. Consult this list for examples; and better, read the ingredients of every pain or anti-fever medication you take to see what’s inside. You might take Tylenol in the evening, then at bedtime take a slug of, say, Nyquil, not realizing it too contains the same drug.

I will let you know what the FDA decides after their meeting at the end of June, but for an interim FDA report, with more details about acetaminophen, click here (pdf).

In summary, acetaminophen can be a wonderful drug, but with a narrow “safety margin”, it deserves special caution.

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big new study: drink one-a-day, live longer

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I have a regular disagreement with a doctor friend of mine. I tell him that most research supports that people who drink a little alcohol each day live longer, and he says no, sorry, that can’t be… (or if he’s in a good mood, he might concede: “yes, but only if it’s red wine”). And I always respond: no, actually, even people who drink a little gin or vodka or whatever each day live longer and with less risk of early death. It’s always the same argument.

So I was happy to see this recent publication of a large, impartial research project (part of the U.S. Health and Retirement Study) from a reliable institution; the University of California San Francisco, which followed 12,519 adults age 55 and over during a four year period with one question: who was more likely to die—of any cause—during the four-year period—those who didn’t drink any alcohol, those who drank “moderately” (one drink per day), or those who drank “heavily” (three or more drinks per day).

They found that people who had one drink per day enjoyed a 28 percent lower risk of dying during the four-year period. The researchers controlled for other factors like race, smoking, obesity, socioeconomic status and so forth to make sure that what made the difference was only the alcohol intake, and not some other factor(s), like that people who could afford a little alcohol each day also were thinner, or had better diets, or wore their seatbelts more, etc.

The study further concluded that people who drank three or more drinks per day increased their risk of dying during the four years by 11%. Those who drank just a little bit—averaging one drink per week—did not show a lower death risk like those who had one drink a day. In this study, the people who drank a little bit, or we might say moderately (one drink per day),  survived the best.

Alcohol and health though is a complex and controversial topic, and it brings out lots of passion and guilt, fear, danger…all of that, in doctors as well as in the general public. Floating around is the concern regarding addiction, and for all of us, that needs to be considered.

If you care to read more about this, and how cancer risk compares with heart risk and alcohol, I suggest you might start with this recent WebMD article.

Now I’ll ask my doctor friend—the one with whom I argue this issue—and see what he thinks about this UC San Francisco study. I suspect he won’t believe it. If you remind me, I’ll tell you what he says.

ps….yes, Buzz the poodle is better

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12 Best And Worst Beverages For Weight Loss

Last Wednesday I presented some information about average weight gain during the holidays, and while the problem may be exaggerated in the media, none of us wants to arrive at New Year’s needing to make a weight loss resolution. More significant, the data indicates that whatever weight you gain during the holidays is especially difficult to lose and keep off, and that year after year, many people’s weight may creep up because of the those cumulative gains.

When we think of high calories, we might think more about what we eat, and less about what we drink, but beverages could be a big part of the problem. There was an interesting WebMD feature last week regarding the best and worst beverages for weight loss. You can watch the slide show here, or if you don’t want to slog through fifteen pages (and see lots of ads), you can read my summary below. I have added my own spin on their recommendations.

Let’s start with the drinks BAD for your diet:

SODA: The single biggest source of calories in the American diet, and switching to diet soda is of questionable help (paradoxically, may just induce you to eat other sweet foods). Best to avoid.

FANCY COFFEES: The ones you buy at coffeeshops with the fancy names that cost $3 to $6. May have close to 600 calories in a large. I detailed these in a recent post.

WINE COOLERS: A 12 oz. bottle may have 190 calories and 22 gm. of carbs. Regular wine or a mix of wine and sparkling water much healthier.

FANCY COCKTAILS: If add sugary syrups, chocolate, or cream watch out. For example, a white Russian has over 700 calories, and a super-size margarita more than 1000. Yikes!

Here are the QUESTIONABLE drinks:

FRUIT JUICE: May have as many calories as soda, but at least has nutritional value. Look for “100% Fruit Juice” on label, and note the calories per 8 oz. serving. Mix with water or sparkling water to cut calories.

SMOOTHIES: If someone else makes for you, probably full of calories. Make your own with low-fat milk and fresh fruit.

Now, the GOOD beverages:

WATER: May fill you up so you eat less. Pass on the bottled water and go for filtered tap water.

VEGETABLE JUICE: Lower in calories than fruit juice and usually more nutritious (look for ones with more fiber, which helps control hunger). Try to find “Low Sodium” versions, as regular often full of salt.

COFFEE: If black, calorie-free. Full of great anti-oxidants, and caffeine is healthy for most people. Again, see my recent post for details.

GREEN TEA: WebMD says it helps with weight loss but that effect is small. Still, it has some caffeine and is full of great phytonutrients, so drink up.

LIGHT BEER: About 50% less calories than regular beer.

LOWER-CALORIE ALCOHOL DRINKS: Not on the WebMD list, but for some people, can be both healthy and low-calorie. This is the topic for next Monday, just in time for New Year’s.

This Wednesday “A Simple, Inexpensive, And Valuable Last-Minute Gift”. In the meantime, enjoy your Holidays!

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