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:
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.
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."
Drugs listed in italics contain more acetaminophen than the 325-milligram limit that will go into effect in 2014:
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.
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, 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.
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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