Percocet, Vicodin, Other Combination Pills to Get Dose Limit, "Black Box’ Warning
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:
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.
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.”
Here’s the FDA’s advice to people who are taking prescription pain drugs that contain acetaminophen:
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, FDA
FDA 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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