What the new FDA recommendations mean-Susan Crandell, BettyConfidential.com
Earlier this month, a Food and Drug Administration advisory panel recommended big changes in the way a popular pain reliever, acetaminophen (the active ingredient in Tylenol), is sold. Citing liver damage that can occur when too much of the drug is taken, it recommended lowering the maximum daily dose from 4,000 mg to 2,600 mg and restricting over-the-counter sales to 325 mg pills or capsules rather than 500 mg (the current dosage of Extra Strength Tylenol). In addition, the panel recommended banning prescription pain pills that combine acetaminophen with an opioids; Vidocin and Percocet are the two best-known.
Let's look at the background for these recommendations. The risk of liver damage is relatively rare, but when it does occur, it can be devastating.
Overdoses of acetaminophen result in 450 deaths and 56,000 emergency-room visits a year, a sobering statistic, but one that must be viewed against the backdrop of how much of the drug is taken each year. It's estimated that almost one in five adult Americans takes some form of acetaminophen over the course of a week.
It seems fairly straightforward to stay out of trouble: just make sure you don't exceed 2,600 mg a day. Trouble is, this can be a lot tougher than you'd think. That's because acetaminophen is an ingredient in OTC and prescription drugs of all types, literally hundreds of them. It's in cold remedies and cough syrups, remedies for headaches, cramps and PMS, and sleep aids.
Because of this, if you take multiple medications, you can ramp up your acetaminophen intake without realizing it. Even if you're looking, you can be fooled; in prescription meds, it is sometimes listed as APAP.
The other issue is the thin line between a safe dose and a potentially dangerous one. One in 10 deaths have occurred in patients who had taken a daily dose between 2,000 and 4,000 mg. In addition, if you have liver disease, or if you have three of more alcoholic drinks a day, you're at increased risk of liver damage from acetaminophen.
This is sobering news, but not the kind of warning that has us running screaming toward our medicine chest, wastebasket in hand. Liver damage may be the side effect du jour, but it is not the only problem pain killers present.
Other drugs you might be tempted to substitute for acetaminophen have their own issues: non-steroidal anti-inflammatory medications (which include aspirin) can cause ulcers and gastrointestinal bleeding, kidney failure, and, yes, liver failure.
Bottom line is to know the limits, to be vigilant and stick to them. No doubt Greg House is already stockpiling Vicodin against the possibility that it might be banned. But for the rest of us, caution and care seem to be the watchwords.