From Our 2011 Archives

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; Codeine Phosphate

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

Capital and Codeine

Acetaminophen; Codeine Phosphate

Suspension; Oral

120mg/ 5mL; 12mg/ 5mL

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

No Current Brand Name

Acetaminophen; Butalbital; Caffeine; Codeine Phosphate

Capsule; Oral

325mg; 50mg; 40mg; 30mg

Fioricet w/ codeine

Acetaminophen; Butalbital; Caffeine; Codeine Phosphate

Capsule; Oral

325mg; 50mg; 40mg; 30mg

Phrenilin with Caffeine and Codeine

Acetaminophen; Butalbital; Caffeine; Codeine Phosphate

Capsule; Oral

325mg; 50mg; 40mg; 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

No Current Brand Name

Acetaminophen; Hydrocodone Bitartrate

Solution; Oral

325mg/ 15mL; 10mg/ 15mL

No Current Brand Name

Acetaminophen; Hydrocodone Bitartrate

Solution; Oral

325mg/ 15mL; 7.5mg/ 15mL

No Current Brand Name

Acetaminophen; Hydrocodone Bitartrate

Solution; Oral

500mg/ 15mL; 10mg/ 15mL

No Current Brand Name

Acetaminophen; Hydrocodone Bitartrate

Solution; Oral

500mg/ 15mL; 7.5mg/ 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; Oxycodone Hydrochloride

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; Tramadol Hydrochloride

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.

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