Limits to Acetaminophen Content in Prescription Combo Products

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1 PL Detail-Document # This PL Detail-Document gives subscribers additional insight related to the Recommendations published in PHARMACIST S LETTER / PRESCRIBER S LETTER July 2012 Limits to Acetaminophen Content in Prescription Combo Products On January 13, 2011, FDA announced that it is asking manufacturers of oral prescription acetaminophen combination products to limit the maximum amount of acetaminophen in these products to 325 mg per tablet, capsule, or other dosage unit, with the exception of intravenous injection. FDA believes that limiting the amount of acetaminophen per tablet, capsule, or other dosage unit in prescription products will reduce the risk of severe liver injury from acetaminophen overdosing, an adverse event that can lead to liver failure, liver transplant, and death. Acetaminophen in prescription products is always found in combination with other active ingredients, including opioid pain relievers. These are known as prescription acetaminophen combination products. Examples of prescription acetaminophen combination products include hydrocodone with acetaminophen (Vicodin, Lortab), and oxycodone with acetaminophen (Tylox, Percocet). Why is FDA limiting the maximum strength of acetaminophen in oral prescription products? FDA continues to receive reports of severe liver injury associated with the use of acetaminophen-containing products. The greatest risk for severe liver injury happens when people take more than the prescribed dose of acetaminophen, take more than one acetaminophen-containing product at the same time, or drink alcohol while taking acetaminophen. Severe liver injury can lead to liver failure, liver transplant, and death. By limiting the maximum amount of acetaminophen in oral prescription products to 325 mg per tablet, capsule, or other dosage unit, patients will be less likely to overdose on acetaminophen if they mistakenly take too many doses of acetaminophen-containing products. Will limiting the maximum amount of acetaminophen in oral prescription products alter the pain reducing effects of these drugs? All oral prescription products containing acetaminophen also contain an additional pain medicine (usually an opioid). There are no data that indicate that taking more than 325 mg of acetaminophen per dosage unit provides more pain relief. Under the new dosage limit, health care professionals can direct patients to take 1 or 2 tablets, capsules, or other dosage units of a prescription product containing 325 mg of acetaminophen up to 6 times a day (12 dosage units) and still not exceed the maximum daily dose of acetaminophen (4000 mg). Will the new dosage limit affect the dosing directions for oral prescription acetaminophen combination products? The new dosage limit will not affect other aspects of prescribing of prescription acetaminophen combination products. The total number of tablets, capsules, or other dosage units that may be prescribed and the time intervals at which they may be prescribed need not change as a result of the lower amount of acetaminophen per dosage unit. For example, if a health care professional previously prescribed 1 or 2 tablets of an oral prescription acetaminophen combination product every 4 to 6 hours, these dosing instructions will not change. A prescription drug containing 325 mg of acetaminophen prescribed at a maximum dosage of 2 tablets every 4 hours will add up to a total daily dose of 3900 mg (3.9 grams), which is less than the 4000 mg recommended maximum daily dose of acetaminophen. Copyright 2012 by Therapeutic Research Center P.O. Box 8190, Stockton, CA ~ Phone: ~ Fax: ~ ~ More...

2 How else is FDA communicating the risk of severe liver injury associated with oral acetaminophen to health care professionals? To communicate the risk of severe liver injury associated with acetaminophen to health care professionals, FDA is requiring a Boxed Warning to be added to the label of all prescription drug products that contain acetaminophen. This Boxed Warning will describe the risk of severe liver injury. A Boxed Warning is FDA s strongest warning in drug labels. The Agency will also continue to work with health care professional organizations to help ensure that health care professionals are aware of the risk of severe liver injury associated with the use of acetaminophen. When will the new limit on the amount of acetaminophen per dosage unit in oral prescription drug products take effect? Drug companies will have three years from the date of publication of the Federal Register Notice (January 14, 2011) to limit the amount of acetaminophen in their oral prescription drug products to 325 mg per dosage unit. How will the new limit on the amount of acetaminophen per dosage unit affect availability of oral prescription acetaminophen combination products? Many oral prescription combination acetaminophen products are currently available in multiple strengths, including 325 mg, in the United States. Some of these products contain up to 750 mg of acetaminophen per tablet, capsule, or other dosage unit. To comply with the new requirement, companies that market oral drug products containing higher strengths of acetaminophen will need to limit the amount of acetaminophen to 325 mg per dosage unit or they may choose to withdraw the drug products. FDA does not predict that this regulatory action will affect patient health care or the options available to patients for the management of their pain. Are there other safety issues regarding prescription acetaminophen that FDA is communicating at this time? FDA is also aware of rare cases of severe allergic reactions (e.g., swelling of the face, (PL Detail-Document #280711: Page 2 of 3) mouth, and throat, difficulty breathing, itching, or rash) that have occurred with the use of acetaminophen. FDA has asked companies to add a new Warning about the risk of allergic reactions, including anaphylaxis, to the label of all prescription acetaminophen-containing products. Is there any additional information that health care professionals need to tell their patients? Health care professionals should advise patients to continue taking their prescription pain medicine as directed. There is no immediate danger to patients who take oral prescription acetaminophen combination products. The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4000 mg within a 24-hour period. Health care professionals should educate patients about how to properly use acetaminophen to avoid liver injury: Advise patients not to take more than the prescribed dose of an acetaminophencontaining medication. Advise patients not to take more than one product that contains acetaminophen. Advise patients to read all prescription and OTC labels to ensure they are not taking multiple acetaminophen-containing products accidentally. A commonly used OTC acetaminophen pain reliever is the brandname Tylenol. Acetaminophen is also found in many other OTC medicines, such as cough and cold medicines, and sinus medicines. Examples of these OTC medicines include NyQuil, Vicks, Coricidin, etc. Advise patients not to drink alcohol while taking acetaminophen-containing medications. Health care professionals should also advise patients to seek medical help immediately if they have taken more acetaminophen than directed or experience swelling of the face, mouth, and throat, difficulty breathing, itching, and rash after taking acetaminophen. Has FDA consulted with outside experts about the safety of acetaminophen products? The risk of liver injury associated with the use of acetaminophen was discussed at the Joint Copyright 2012 by Therapeutic Research Center P.O. Box 8190, Stockton, CA ~ Phone: ~ Fax: ~ ~ More...

3 (PL Detail-Document #280711: Page 3 of 3) Meeting of the FDA Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and Anesthetic and Life Support Drugs Advisory Committee, held on June 29-30, 2009 (the complete safety reviews and background information discussed at this meeting are available at mitteesmeetingmaterials/drugs/drugsafetyandri skmanagementadvisorycommittee/ucm h tm). The above excerpts are reprinted from the January 2011, FDA Q&A concerning the limits to acetaminophen content in prescription combo products. /InformationbyDrugClass/ucm htm. (Accessed June 13, 2012). Users of this PL Detail-Document are cautioned to use their own professional judgment and consult any other necessary or appropriate sources prior to making clinical judgments based on the content of this document. Our editors have researched the information with input from experts, government agencies, and national organizations. Information and internet links in this article were current as of the date of publication. Cite this document as follows: PL Detail-Document, Limits to Acetaminophen Content in Prescription Combo Products. Pharmacist s Letter/Prescriber s Letter. July Evidence and Recommendations You Can Trust 3120 West March Lane, P.O. Box 8190, Stockton, CA ~ TEL (209) ~ FAX (209) Copyright 2012 by Therapeutic Research Center Subscribers to the Letter can get PL Detail-Documents, like this one, on any topic covered in any issue by going to or

4 A Note from Your Pharmacist: Phaseout of High-Dose Rx Acetaminophen Combination Products Date: Dear, I want to share information about certain Rx acetaminophen combination products that will no longer be manufactured after January 14, This includes any Rx acetaminophen combination product that contains more than 325 mg of acetaminophen per capsule, tablet, or other dosage unit. Examples of these products include Esgic-Plus, Lorcet, Lortab, some strengths of Percocet, and a number of generics. FDA recommended that this phaseout happen over three years, ending this coming January. Some of the products have already been discontinued and supplies in pharmacies have dwindled. Some products, such as Vicodin, have already been reformulated with less acetaminophen. Of course, the intent of this action is to improve patient safety and reduce the risk of inadvertent acetaminophen overdose. As you know, acetaminophen is the number one cause of acute liver failure. As little as 6 g/day of acetaminophen for two days can cause liver toxicity in some patients. And combination products with more than 325 mg of acetaminophen per capsule or tablet provide only modestly better pain relief compared to those that have less acetaminophen. Combination products that currently contain 325 mg or less of acetaminophen per tablet or capsule include hydrocodone/acetaminophen combos such as Norco, Xodol, and most strengths of Percocet (oxycodone/acetaminophen). Concerning your patient,, and this patient s Rx for: (medication, dose, dosing interval) I m requesting authorization to switch to: (medication, dose, dosing interval) If you agree with this switch, please fax or phone a new Rx to us at - - (fax) or - - (phone). Please feel free to contact me at any time if you would like more information about product availability or assistance with product selection. Sincerely, Prepared for use by Pharmacist s Letter subscribers. Copyright 2013 by Therapeutic Research Center. [November 2013]

5 Safe Use of Acetaminophen (Tylenol) What is Acetaminophen? Acetaminophen is found in products like Tylenol. It s used for pain and to lower fever. Acetaminophen works well and is usually safe as long as it s taken the right way. What Products Have Acetaminophen in Them? Acetaminophen is in many over-the-counter (OTC) medicines found on store shelves. Some of these medicines just have acetaminophen in them. But some have acetaminophen with other drugs. Medicines used for allergies, colds, or the flu often have acetaminophen. Prescription drugs for pain may also have acetaminophen. You should never take more than one medicine that has acetaminophen at a time. It is very important to read the label and look for the word ACETAMINOPHEN. If an OTC medicine has acetaminophen it should say acetaminophen on the front of the package. You can also look for acetaminophen on the Drug Facts label (under the Active Ingredients section) on the bottle. If you are taking a prescription drug for pain, ask your pharmacist if it has acetaminophen in it. How Much Acetaminophen Should I Take? The dose of acetaminophen will depend on the product you are using. It is important to check the product label and follow the directions very carefully. If you have three or more alcoholic drinks a day, ask your pharmacist or prescriber if it s okay for you to take acetaminophen. They will be able to tell you if it s okay to take acetaminophen, and how much to take. What About Children? Children are at special risk of getting too much acetaminophen. The dose for children changes as they grow bigger. There are also different acetaminophen products for different age groups. This can be confusing. It is important to follow the directions on the label of the product you are using. If the dose for your child s age or weight is not on the label, ask your pharmacist or prescriber. If you are using a liquid acetaminophen product, be sure to use the measuring tool that comes with the medicine. DO NOT use a kitchen spoon. Keep a record of when your child gets their medicine. This way your child will not get it more often than they should. What if You Take Too Much Acetaminophen? Acetaminophen is a safe drug if taken at the right dose. But too much acetaminophen can hurt the liver. People who take too much acetaminophen might feel sick to their stomach, throw up, and have belly pain. But some people will not feel sick at all. Some people have died after taking too much acetaminophen. If you or your child has taken too much acetaminophen, call a poison control center right away. In the U.S. the number is In Canada, the number is different for each province. You can find the right phone number on the first page of your local telephone book or online at [This handout may not cover all possible information. It does not replace the need for professional medical care. Always follow the instructions from your healthcare provider.][august 2011; ] Prepared for the subscribers of Pharmacist s Letter / Prescriber s Letter to give to their patients. Copyright 2011 by Therapeutic Research Center ~

6 Uso seguro del acetaminofeno (Tylenol) Qué es acetaminofeno? El acetaminofeno se encuentra en productos como Tylenol. Se utiliza para el dolor y para bajar la fiebre. El acetaminofeno funciona bien y su uso generalmente es seguro... siempre y cuando se tome de la manera correcta. Qué productos contienen acetaminofeno? El acetaminofeno se encuentra en muchos de los medicamentos de venta libre (OTC) que se encuentran en los estantes de los negocios. Algunos de estos medicamentos sólo contienen acetaminofeno. Sin embargo, otros contienen acetaminofeno junto con otros medicamentos. Los medicamentos utilizados para las alergias, los resfriados o la gripe a menudo contienen acetaminofeno. Los medicamentos para el dolor de venta con receta médica pueden también contener acetaminofeno. Usted nunca debe tomar al mismo tiempo más de un medicamento que contenga acetaminofeno. Es muy importante leer la etiqueta y buscar la palabra ACETAMINOFENO. Si un medicamento de venta libre (OTC) contiene acetaminofeno debe decir "acetaminofeno" al frente del paquete. Usted puede también buscar la palabra "acetaminofeno" en la etiqueta de Información del Medicamento (en la sección de ingredientes activos) en la botella. Si usted está tomando un medicamento de venta con receta médica para el dolor, pregúntele a su farmacéutico si este contiene acetaminofeno. Cuánto acetaminofeno debo tomar? La dosis de acetaminofeno depende del producto que esté usando. Es importante revisar la etiqueta del producto y seguir cuidadosamente las instrucciones. Si usted toma tres o más bebidas alcohólicas al día, pregúntele a su farmacéutico o médico si está bien que usted tome acetaminofeno. Ellos le podrán decir si está bien que tome acetaminofeno y cuánto debe tomar. Qué pasa con los niños? Los niños en especial corren un mayor riesgo de que se les administre demasiado acetaminofeno. La dosis para los niños cambia a medida que los niños crecen. Hay también diferentes productos de acetaminofeno para las distintas edades. Esto puede ser confuso. Es importante seguir las instrucciones que aparecen en la etiqueta del producto que está utilizando. Si la dosis para la edad o el peso de su hijo/a no están en la etiqueta, pregúntele a su farmacéutico o médico. Si está usando un producto líquido de acetaminofeno, asegúrese de usar el dispositivo para medir la cantidad que viene con el medicamento. NO USE una cuchara de cocina. Mantenga un registro de cuando su hijo recibe su medicina. De esta manera el niño no recibirá el medicamento con mayor frecuencia que lo que debe. Qué pasa si toma demasiado acetaminofeno? El acetaminofeno es un medicamento seguro si se toma en la dosis correcta. Pero demasiado acetaminofeno puede dañar el hígado. Las personas que toman demasiado acetaminofeno podrían sentirse mal del estómago, vomitar y tener dolor de estomago. Pero también puede Prepared for the subscribers of Pharmacist s Letter / Prescriber s Letter to give to their patients. Copyright 2011 by Therapeutic Research Center ~

7 Uso seguro del acetaminofeno (Tylenol) haber otras personas que no sientan ningún malestar. Algunas personas han muerto después de haber tomado demasiado acetaminofeno. Si usted o su hijo ha tomado demasiado acetaminofeno, llame a un centro de control de envenenamiento de inmediato. En los EE.UU. el número es En Canadá, el número es diferente para cada provincia. Usted puede encontrar el número de teléfono correcto en la primera página de su guía telefónica local o en línea a través de internet en [Agosto 2011] Prepared for the subscribers of Pharmacist s Letter / Prescriber s Letter to give to their patients. Copyright 2011 by Therapeutic Research Center ~