Porter Hospital Blog

Today an advisory group that the FDA created  recommended that the drugs Vicodin and Percocet – which are combinations of a narcotic and Acetaminophen(the active ingredient in Tylenol) – be removed from use.  There are forms of each of these narcotics that do not contain acetaminophen, and this recommendation would not affect those single ingredient narcotics.

The panel was concerned that more of the unintentional overdoses with acetaminophen occurred with these combination drugs.  The panel’s other suggestion, if Vicodin and Percocet are retained on the market, was to put a black box warning on the medications.  This warning is the FDA’s signal that a very serious problem is associated with use of the medication.

The panel also suggested decreasing the recommended dose from 1000 mg to 650 mg.  This would be the equivalent of decreasing from 2 Extra Strength Tylenol per dose to 2 Regular strength Tylenol per dose.

As we discussed on The Denver Channel 7 -this is not a final decision, but it brings up the very important topic of safe use of Acetaminophen.  Acetaminophen is a very useful and safe drug when used within certain dosing limits.  However, when used at doses higher than the recommended intake over one dose, in doses higher than recommended in a day, which for healthy adults is 4 grams per day,  it can cause irreversible liver damage.

One problem noted by the FDA is that Acetaminophen is an ingredient in many combination medications for colds, flu, coughs, headaches.   Because it is one of many ingredients in many medications, if consumers do not read the ingredients of the medications they are taking, they can end up taking dangerous doses of Acetaminophen without realizing that they have overdosed themselves.

People who have liver disease, who drink more than 2 alcoholic drinks per day, and those who are on certain medications  should not use Acetaminophen containing products without consulting their physician.

Because of the number of products that contain acetaminophen, our hospital  pharmacists monitor each patient’s total doses of acetaminophen from all the medications they are prescribed, and intervene to stop further acetaminophen being given when the doses reach the maximum safe dose.  We also train the nurses and physicians to monitor total acetaminophen dosage in order to have many people monitoring this very important safety issue. 

What Should This Mean To You?

It is important to remember that within the appropriate range of dosing, acetaminophen is an effective and safe pain medication.  However, there are several things that you can do to assure that you use it appropriately:

1) Always read all the ingredients in the over the counter  and prescription medications you take

2) The maximum dose that is safe is different for children – so be sure and check with your pediatrician regarding safe dosing

3) Talk to your pharmacist or physician about how much acetaminophen is safe for you and be sure to tell them all the medications and over the counter products you use

4) If you have liver disease or drink more than 2 alcholic drinks per day, contact your physician prior to taking any product containing acetaminophen

Other sites that may contain information that will help you:

Porter Adventist Hospital/Centura Health Library

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/SafeUseofOver-the-CounterPainRelieversandFeverReducers/default.htm - this FDA website has information in Spanish as well as numerous links in English

http://tylenol.com/page.jhtml?id=tylenol/news/subp_fda.inc - this is the official site from the manufacturer’s of Tylenol (Johnson and Johnson) with a great deal of safety information

As always, good questions and taking the time to read directions and other information that you are given create more safety for you, the  patient,

Dr. Dianne