FDA Warns of Acetaminophen in Prescription Pain Drugs

Percocet, Vicodin, Other Combination Pills to Get Dose Limit, "Black Box' Warning
By  Daniel J. DeNoon
WebMD Health News
Reviewed by Laura J. Martin, MD

Jan. 13, 2011 - The FDA is warning about the dangers of acetaminophen in popular prescription pain drugs, but did it go far
enough?
Acetaminophen, the active ingredient in Tylenol, is found in a wide range of over-the-counter and prescription drugs. At normal
doses, when not taken with alcohol, acetaminophen is a very safe drug. But it's easy to take too much -- a big mistake that can
lead to serious liver damage.
Damage can occur when a person with normal liver function takes 4,000 milligrams or more of acetaminophen in a single day.
That's easy to do if a person is taking several medications and is not aware that each contains a powerful dose of
acetaminophen.
The result: some 56,000 emergency-room visits, 26,000 hospitalizations, and 458 deaths a year. Acetaminophen is the leading
cause of acute liver failure in the U.S., causing some 1,600 cases a year.
Now the FDA is taking two steps. Both affect only prescription drugs. The FDA action does not affect any medication sold over
the counter. The FDA say that in three years:

 Prescription pain drugs can contain no more than 325 milligrams of acetaminophen per pill or spoonful. Currently, some
of these drugs contain as much as 750 milligrams of acetaminophen.
 Prescription pain drugs will carry the FDA's strongest "black box" warning label. That label will warn of the risk of
serious liver injury.

Nearly all the prescription drugs affected by the FDA action combine acetaminophen with an opioid. Popular brand names
include Vicodin, Percocet, Lortab, Fioricet, and Roxicet.
Currently, the labels that pharmacies put on these prescription drugs make it hard to tell how much acetaminophen a patient is
getting. Often acetaminophen is given the cryptic abbreviation "APAP," which even some doctors have a hard time interpreting.
"When taken as directed, acetaminophen is a very safe product. Our goal is to make it even safer," Sandra Kweder, deputy
director of the FDA's office of new drugs, said at a news teleconference.
The FDA action comes a year and a half after an FDA advisory committee voted for much stronger action. The panel voted 20-
17 to ban all combination acetaminophen/opioid pain pills. And it voted 24-13 to limit the maximum acetaminophen dosage
in over-the-counter products -- an action Kweder says the FDA isn't yet ready to take.
"We have not made a decision about what action to take with over-the-counter products. We continue to consider our options,"
Kweder said.
Over-the-counter "extra strength" formulations of cold and cough remedies contain 500 milligrams of acetaminophen per pill or
spoonful (or even more in extended-release formulations).
"It is extremely poor judgment on the part of the FDA to have failed to take action concerning this major source of
acetaminophen consumption and, consequently, acetaminophen toxicity," Sidney Wolfe, MD, director of Public Citizen's Health
Research Group, says in a news release.

Pain Pills Still Equally Effective, Still on the Market

Kweder said that limiting the acetaminophen in prescription pain pills to 325 milligrams will not make the drugs any less effective.
Yet she also said that acetaminophen is included in these drugs as an additional source of pain relief -- and not as a way of
limiting drug abuse by making the opioid drugs toxic at high doses.
At the two-day June 2009 advisory committee meeting, Cleveland Clinic pain expert and panel member Edward Covington, MD,
took a different view.
"Basically we have limited [hydrocodone] abuse, as was said yesterday, by combining it with a poison [acetaminophen] so that
you can't abuse it as easily as you can abuse OxyContin," Covington said. "And the whole idea of protecting the public by mixing
a poison with your medicine I find troubling, and in essence that's what we've done."
 FDA Advice to Patients Taking Acetaminophen-Containing Drugs

Here's the FDA's advice to people who are taking prescription pain drugs that contain acetaminophen:

 Acetaminophen-containing prescription products are safe and effective when used as directed, though all medications
carry some risks.
 Do not stop taking your prescription pain medicine unless told to do so by your health care professional.
 Carefully read all labels for prescription and OTC medicines and ask the pharmacist if your prescription pain medicine
contains acetaminophen.
 Do not take more than one product that contains acetaminophen at any given time.
 Do not take more of an acetaminophen-containing medicine than directed.
 Do not drink alcohol when taking medicines that contain acetaminophen.
 Stop taking your medication and seek medical help immediately if you think you have taken more acetaminophen than
directed.
 Stop taking your medication and seek medical help immediately if you experience allergic reactions such as swelling of
the face, mouth, and throat, difficulty breathing, itching, or rash.

List of Acetaminophen-Containing Prescription Drugs

This is the FDA's list of prescription drugs affected by today's action. Keep in mind that the FDA is giving drugmakers three years
to comply, so changes won't be seen right away.

Drugs listed in italics contain more acetaminophen than the 325-milligram limit that will go into effect in 2014:
Brand Name Generic Name Dosage Form Strength
No Current Brand Name Acetaminophen; Aspirin; CodeinePhosphate Capsule; Oral 150mg; 180mg; 30mg
No Current Brand Name Acetaminophen; Caffeine; Dihydrocodeine Bitartrate Capsule; Oral 356.4mg; 30mg; 16mg
No Current Brand Name Acetaminophen; Caffeine; Dihydrocodeine Bitartrate Tablet; Oral 712.8mg; 60mg; 32mg
No Current Brand Name Acetaminophen; Codeine Phosphate Solution; Oral 120mg/ 5mL; 12mg/ 5mL
No Current Brand Name Acetaminophen; Codeine Phosphate Tablet; Oral 300mg; 15mg
No Current Brand Name Acetaminophen; Codeine Phosphate Tablet; Oral 650mg; 30mg
No Current Brand Name Acetaminophen; Codeine Phosphate Tablet; Oral 650mg; 60mg
Suspension;
Capital and Codeine Acetaminophen; Codeine Phosphate 120mg/ 5mL; 12mg/ 5mL
Oral
Tylenol W/ Codeine No. 3 Acetaminophen; Codeine Phosphate Tablet; Oral 300mg; 30mg
Tylenol W/ Codeine No. 4 Acetaminophen; Codeine Phosphate Tablet; Oral 300mg; 60mg
No Current Brand Name Acetaminophen; Butalbital; Caffeine Tablet; Oral 500mg; 50mg; 40mg
Esgic-Plus Acetaminophen; Butalbital; Caffeine Tablet; Oral 500mg; 50mg; 40mg
No Current Brand Name Acetaminophen; Butalbital; Caffeine Capsule; Oral 500mg; 50mg; 40mg
Esgic-Plus Acetaminophen; Butalbital; Caffeine Capsule; Oral 500mg; 50mg; 40mg
No Current Brand Name Acetaminophen; Butalbital; Caffeine Tablet; Oral 325mg; 50mg; 40mg
Fioricet Acetaminophen; Butalbital; Caffeine Tablet; Oral 325mg; 50mg; 40mg
Acetaminophen; Butalbital; Caffeine; Codeine 325mg; 50mg; 40mg;
No Current Brand Name Capsule; Oral
Phosphate 30mg
Acetaminophen; Butalbital; Caffeine; Codeine 325mg; 50mg; 40mg;
Fioricet w/ codeine Capsule; Oral
Phosphate 30mg
Phrenilin with Caffeine and Acetaminophen; Butalbital; Caffeine; Codeine 325mg; 50mg; 40mg;
Capsule; Oral
Codeine Phosphate 30mg
Anexsia Acetaminophen; Hydrocodone Bitartrate Tablet; Oral 500mg; 5mg
Anexsia Acetaminophen; Hydrocodone Bitartrate Tablet; Oral 750mg; 10mg
Anexsia 5/ 325 Acetaminophen; Hydrocodone Bitartrate Tablet; Oral 325mg; 5mg
Anexsia 7.5/ 325 Acetaminophen; Hydrocodone Bitartrate Tablet; Oral 325mg; 7.5mg
Anexsia 7.5/ 650 Acetaminophen; Hydrocodone Bitartrate Tablet; Oral 650mg; 7.5mg
Co-Gesic Acetaminophen; Hydrocodone Bitartrate Tablet; Oral 500mg; 5mg
No Current Brand Name Acetaminophen; Hydrocodone Bitartrate Capsule; Oral 500mg; 5mg
325mg/ 15mL; 10mg/
No Current Brand Name Acetaminophen; Hydrocodone Bitartrate Solution; Oral
15mL
325mg/ 15mL; 7.5mg/
No Current Brand Name Acetaminophen; Hydrocodone Bitartrate Solution; Oral
15mL
500mg/ 15mL; 10mg/
No Current Brand Name Acetaminophen; Hydrocodone Bitartrate Solution; Oral
15mL
500mg/ 15mL; 7.5mg/
No Current Brand Name Acetaminophen; Hydrocodone Bitartrate Solution; Oral
15mL
No Current Brand Name Acetaminophen; Hydrocodone Bitartrate Tablet; Oral 300mg; 10mg
No Current Brand Name Acetaminophen; Hydrocodone Bitartrate Tablet; Oral 300mg; 5mg
No Current Brand Name Acetaminophen; Hydrocodone Bitartrate Tablet; Oral 300mg; 7.5mg
No Current Brand Name Acetaminophen; Hydrocodone Bitartrate Tablet; Oral 500mg; 2.5mg
No Current Brand Name Acetaminophen; Hydrocodone Bitartrate Tablet; Oral 500mg; 7.5mg
No Current Brand Name Acetaminophen; Hydrocodone Bitartrate Tablet; Oral 650mg; 10mg
Lortab Acetaminophen; Hydrocodone Bitartrate Tablet; Oral 500mg; 10mg
Lortab Acetaminophen; Hydrocodone Bitartrate Tablet; Oral 500mg; 5mg
Norco Acetaminophen; Hydrocodone Bitartrate Tablet; Oral 325mg; 10mg
Norco Acetaminophen; Hydrocodone Bitartrate Tablet; Oral 325mg; 5mg
Norco Acetaminophen; Hydrocodone Bitartrate Tablet; Oral 325mg; 7.5mg
Vicodin Acetaminophen; Hydrocodone Bitartrate Tablet; Oral 500mg; 5mg
Vicodin Es Acetaminophen; Hydrocodone Bitartrate Tablet; Oral 750mg; 7.5mg
Vicodin Hp Acetaminophen; Hydrocodone Bitartrate Tablet; Oral 660mg; 10mg
Zydone Acetaminophen; Hydrocodone Bitartrate Tablet; Oral 400mg; 10mg
Zydone Acetaminophen; Hydrocodone Bitartrate Tablet; Oral 400mg; 5mg
Zydone Acetaminophen; Hydrocodone Bitartrate Tablet; Oral 400mg; 7.5mg
Oxycet Acetaminophen; OxycodoneHydrochloride Tablet; Oral 325mg; 5mg
No Current Brand Name Acetaminophen; Oxycodone Hydrochloride Tablet; Oral 300mg; 10mg
No Current Brand Name Acetaminophen; Oxycodone Hydrochloride Tablet; Oral 300mg; 2.5mg
No Current Brand Name Acetaminophen; Oxycodone Hydrochloride Tablet; Oral 300mg; 5mg
No Current Brand Name Acetaminophen; Oxycodone Hydrochloride Tablet; Oral 300mg; 7.5mg
No Current Brand Name Acetaminophen; Oxycodone Hydrochloride Tablet; Oral 400mg; 10mg
No Current Brand Name Acetaminophen; Oxycodone Hydrochloride Tablet; Oral 400mg; 2.5mg
No Current Brand Name Acetaminophen; Oxycodone Hydrochloride Tablet; Oral 400mg; 5mg
No Current Brand Name Acetaminophen; Oxycodone Hydrochloride Tablet; Oral 400mg; 7.5mg
No Current Brand Name Acetaminophen; Oxycodone Hydrochloride Tablet; Oral 500mg; 10mg
Percocet Acetaminophen; Oxycodone Hydrochloride Tablet; Oral 325mg; 10mg
Percocet Acetaminophen; Oxycodone Hydrochloride Tablet; Oral 325mg; 2.5mg
Percocet Acetaminophen; Oxycodone Hydrochloride Tablet; Oral 325mg; 5mg
Percocet Acetaminophen; Oxycodone Hydrochloride Tablet; Oral 325mg; 7.5mg
Percocet Acetaminophen; Oxycodone Hydrochloride Tablet; Oral 500mg; 7.5mg
Percocet Acetaminophen; Oxycodone Hydrochloride Tablet; Oral 650mg; 10mg
Roxicet Acetaminophen; Oxycodone Hydrochloride Solution; Oral 325mg/ 5mL; 5mg/ 5mL
Roxicet Acetaminophen; Oxycodone Hydrochloride Tablet; Oral 325mg; 5mg
Roxicet 5/ 500 Acetaminophen; Oxycodone Hydrochloride Tablet; Oral 500mg; 5mg
Roxilox Acetaminophen; Oxycodone Hydrochloride Capsule; Oral 500mg; 5mg
Tylox Acetaminophen; Oxycodone Hydrochloride Capsule; Oral 500mg; 5mg
Talacen Acetaminophen; Pentazocine Hydrochloride Tablet; Oral 650mg; EQ 25mg BASE
Ultracet Acetaminophen; TramadolHydrochloride Tablet; Oral 325mg; 37.5mg
SOURCES: News releases, FDAFDA news teleconference, Jan. 13, 2011.Sandra Kweder, deputy director,office of new drugs,
FDA.FDA web site.News release, Public Citizen.Transcript of the June 29-30 joint meeting of the drug safety and risk
management, nonprescription drugs, and anesthetic and life support advisory committees, FDA web site.
©2011 WebMD, LLC. All Rights Reserved.

Reaction:
The best way to avoid the danger of taking the over-the-counter drug like the most often
used medication for fever and pain reliever we should not practice to do the self-medication but
instead we should always first make an appointment with our doctor to see what the medication
to take. Even this kind of medication there are instances that our system can be affected with
the side effects when it’s misused.
I know that most of us cannot always see the doctor if there are unusual feelings, so were
just do self-medication just to relief the unwanted feeling (ex. Pain). But the way to ensure our
life is to practice visiting the doctor because life can’t be replace but money can earn.

Tagle, Joy Antonette E.

BSN 2-A