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Patients May Receive Too Much Acetaminophen in Hospital

Posted 5 days ago by Drugs.com

WEDNESDAY, May 23 – Roughly 2.5 percent of admitted hospital patients may receive more than the safe daily cumulative dose of the pain-reliever acetaminophen, best known as Tylenol, on at least one day, according to a new U.S. study. Patients on more than one drug containing acetaminophen often consume more than the recommended 4 grams per day of the drug, the researchers from Thomas Jefferson University Hospital in Philadelphia found. Together, two tablets of extra-strength Tylenol contain 1 gram of acetaminophen, commonly used to relieve pain and reduce fever. Over the course of two years, researchers led by Dr. Jesse Civan examined 46,000 hospital admissions and the medications those patients were given. They found that on at least one day of hospitalization, roughly 1,100 patients received more than 4 grams of acetaminophen in the form of Tylenol, Percocet and similar drugs. The ... Read more

FDA Medwatch Alert: Infants' Tylenol Oral Suspension, 1 oz. Grape: Recall - Dosing System Complaints

Posted 17 Feb 2012 by Drugs.com

ISSUE: McNeil Consumer Healthcare notified the public of a recall of seven lots (approximately 574,000 bottles) of Infants’ TYLENOL Oral Suspension, 1 oz. Grape. There were complaints from consumers who reported difficulty using the Infants’ TYLENOL SimpleMeasure dosing system. SimpleMeasure includes a dosing syringe, which a parent or caregiver inserts into a protective cover, or “flow restrictor,” at the top of the bottle to measure the proper dose. In some cases, the flow restrictor was pushed into the bottle when inserting the syringe. BACKGROUND: Infants’ TYLENOL is an over-the-counter (OTC) product indicated as a pain reliever/fever reducer. The product was distributed nationwide in the United States. RECOMMENDATION: If the flow restrictor is pushed into the bottle, the parent or caregiver should not use the product. See the Press Release for lot number and UPC codes of affected pr ... Read more

Faulty Dosing Device Prompts Recall of Infants' Tylenol

Posted 17 Feb 2012 by Drugs.com

FRIDAY, Feb. 17 – A potentially faulty dosing system on bottles of Infants' Tylenol has prompted McNeil Consumer Healthcare, a division of Johnson & Johnson, to recall all of the product. The voluntary recall comes in response to some consumer complaints about the product's so-called SimpleMeasure dosing system, which dispenses measured doses of the medication. The system includes a dosing syringe that an adult inserts into the cover at the top of the bottle. It's supposed to limit the amount of Tylenol that can be delivered in a single dose, according to the company. In some cases, inserting the syringe pushed this "flow restrictor" into the bottle. "Parents can continue to use the product as long as the flow restrictor is in place," Johnson & Johnson spokeswoman Bonnie Jacobs said. "If the flow restrictor does push into the bottle, then they should stop using it and contact us." ... Read more

IV Acetaminophen Linked to More Child Overdoses

Posted 27 Jan 2012 by Drugs.com

FRIDAY, Jan. 27 – Following the U.S. Food Drug Administration's approval last year of an intravenous formulation of acetaminophen for fever and pain in a hospital setting, researchers warn that use of the preparation could lead to serious overdoses, particularly among the youngest patients. The problem: There is confusion over measurement guidelines – milligrams vs. milliliters, to be specific – that can result in the accidental administration of doses that are up to 10 times more than the proper amount. "This product would be given in a health care facility," said study co-author Dr. Richard Dart, from the Rocky Mountain Poison and Drug Center at Denver Health in Colorado. "And thus, the overdose ends up being from a miscalculation by a health care provider." "In theory, the risk to the child is that they could develop serious liver injury," Dart added. "Liver injury is avoided if ... Read more

FDA Medwatch Alert: Liquid Acetaminophen marketed for infants: Drug Safety Communication - Potential for Dosing Errors

Posted 22 Dec 2011 by Drugs.com

[Posted 12/22/2011] ISSUE: The FDA is informing the public that an additional concentration of liquid acetaminophen marketed for “infants” (160 mg/5 mL) is now available. This change in the concentration will affect the amount of liquid given to an infant, and should be especially noted if someone is accustomed to using the 80 mg /0.8 mL or 80 mg/mL concentrations of liquid acetaminophen. BACKGROUND: Over-the-Counter (OTC) Liquid acetaminophen is used to temporarily reduce fever and relieve minor aches and pains due to the common cold, flu, headache, minor sore throat, and toothache. Acetaminophen is marketed under brand names such as Tylenol, Little Fevers, Triaminic, Infant/Pain Reliever, Pedia Care, Triaminic Infants’ Syrup Fever Reducer Pain Reliever and other store brands (e.g., Rite Aid, CVS, Walgreens brand, etc.). This change in the concentration will affect the amount of li ... Read more

Infant Vaccines May Work Better If Given in Afternoon

Posted 30 Nov 2011 by Drugs.com

WEDNESDAY, Nov. 30 – As many parents can attest, a rough night may follow when their baby has been to the doctor for their first shots, due to increased fussiness or fever from the immunizations. But a new study suggests that the time of day that the shots are given may make a difference in both sleep and immune response. Research has shown that immunizations "take hold" more strongly when an infant has a long, deep sleep afterward, which is why some parents give acetaminophen (Tylenol) proactively. According to the new study, published online Nov. 28 and in the December print issue of Pediatrics, infants may sleep more soundly when their shots are given after 1:30 p.m., regardless of whether they have been given any medication. In the study of 70 infants who were getting their first series of vaccines at around 2 months of age, mothers either were told to give their infants a ... Read more

Too Much Acetaminophen Over Time May Damage Liver

Posted 22 Nov 2011 by Drugs.com

TUESDAY, Nov. 22 – Taking slightly too much of the pain reliever acetaminophen (best known by the brand name Tylenol) over time can lead to an overdose that can cause liver failure and death, according to a new study. These "staggered overdoses" can occur when people have ongoing pain and repeatedly take a little more acetaminophen than they should, explained Dr. Kenneth Simpson, author of the study, published Nov. 22 in the British Journal of Clinical Pharmacology. "They haven't taken the sort of single-moment, one-off massive overdoses taken by people who try to commit suicide, but over time the damage builds up, and the effect can be fatal," Simpson said in a journal news release. He and his colleagues analyzed data from 663 patients with acetaminophen-induced liver injury who were admitted to the Royal Infirmary of Edinburgh, Scotland between 1992 and 2008. In the U.K. and ... Read more

Experts Debate Tylenol's Safety for Asthmatic Kids

Posted 7 Nov 2011 by Drugs.com

MONDAY, Nov. 7 – Taken in the proper dose, acetaminophen has long been considered one of the safest over-the-counter medications. It's approved for use in children, and many obstetricians are even OK with its use during pregnancy. But an Ohio pediatrician thinks it's time to rein in use of acetaminophen – more popularly known as Tylenol – particularly in people with asthma. "The fundamental issue is that there's an epidemiological problem associated with acetaminophen and asthma," explained Dr. John McBride, vice chair of the department of pediatrics and director of the Robert T. Stone Respiratory Center at Akron Children's Hospital. "Is that because acetaminophen contributes to asthma, or is it just because people with asthma tend to take acetaminophen?" he said. Until a large-scale study definitively answers that question, McBride said, "I think we owe it to our patients and their ... Read more

Health Tip: Alcohol Can Interact With Medications

Posted 25 Oct 2011 by Drugs.com

-- Over-the-counter medications may seem safer because they don't require a prescription. But they can still interact badly when alcohol enters the mix. The American Academy of Family Physicians mentions these popular medications that may have adverse effects if mixed with alcohol: NSAID pain relievers, which may lead to gastrointestinal bleeding if taken while consuming as few as two alcoholic drink per week. Acetaminophen, which may cause liver damage when taken with alcohol. Some OTC antihistamines can make you drowsy when taken with alcohol. Decongestants and cough medications that contain the cough suppressant dextromethorphan can increase drowsiness when taken with alcohol. Herbal supplements, such as kava kava, St. John's wort or valerian root, may increase drowsiness if taken with alcohol. Read more

Over Half of Adverse Drug Reactions in Hospitals Are Preventable: Study

Posted 9 Sep 2011 by Drugs.com

FRIDAY, Sept. 9 – More than one-half of all adverse drug reactions treated in hospitals and emergency care are preventable, according to a new study. In addition, prior research has shown that many preventable drug reactions – which include drug overdoses and internal bleeding associated with the improper use of blood thinners and painkillers – are life-threatening, said the Swedish researchers. This widespread problem, which is even more common among the elderly, has important implications for health care systems, they said. There are many reasons for the high numbers of preventable adverse drug reactions, according to Katja Hakkarainen, a pharmacist from the Nordic School of Public Health, Gothenburg. These may include "poor coordination of care, lack of time and knowledge among health professionals, and lack of patient education," she said in an International Pharmaceutical ... Read more

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Hospitalized Kids May Receive Up to 35 Meds a Week

Posted 6 Sep 2011 by Drugs.com

TUESDAY, Sept. 6 – Some children, especially those with rare conditions, receive many different drugs while in the hospital, a new study finds. Acetaminophen, albuterol and antibiotics were the drugs most commonly given to hospitalized children, the researchers said. They also found an association between length of hospital stay and the number of drugs given to children. On the first day in children's hospitals, patients younger than 1 year at the 90th percentile of daily medication use received 11 drugs and those 1 year or older received 13 drugs. In general hospitals, patients younger than 1 year received 8 drugs and those 1 year or older received 12 drugs. By the seventh day of hospitalization in children's hospitals, patients younger than 1 year at the 90th percentile of total use of different medications had received 29 drugs and patients 1 year and older had received 35 drugs. In ... Read more

Baby's Fever May Not Signal Teething

Posted 10 Aug 2011 by Drugs.com

WEDNESDAY, Aug. 10 – If a baby is cranky, drooling and running a fever, teething often gets the blame. But a new study finds that while a baby's temperature rises slightly on the day he or she actually cuts a tooth, fever is not a symptom of teething – though the drooling and crankiness can be. "There was no association between fever and the eruption of primary teeth," said study author Joana Ramos-Jorge, a doctoral student at the Universidade Federal de Minas Gerais in Brazil. "This result surprised me because, like much of the population, I also believed that a fever could be a sign of tooth eruption." And though babies are more prone to symptoms such as irritability, sleep disturbances and increased salivation on the day the day tooth erupts and the day after, researchers could not tell which babies were about to cut a tooth based on those symptoms the day before, according to the ... Read more

McNeil Consumer Healthcare Announces Plans for New Dosing Instructions for Tylenol Products

Posted 28 Jul 2011 by Drugs.com

FORT WASHINGTON, Pa., July 28, 2011 /PRNewswire/ – McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. ("McNeil") today announced plans for new dosing instructions lowering the maximum daily dose for single-ingredient Extra Strength Tylenol (acetaminophen) products sold in the U.S. from 8 pills per day (4,000 mg) to 6 pills per day (3,000 mg). The change is designed to help encourage appropriate acetaminophen use and reduce the risk of accidental overdose. Acetaminophen, the active ingredient in Tylenol, can be found in more than 600 over-the-counter (OTC) and prescription medications, such as Tylenol, Sudafed Triple Action™, NyQuil, Percocet and Vicodin.* Acetaminophen is used by more than 50 million Americans each week to treat conditions such as pain, fever and aches and pains associated with cold and flu symptoms. "Acetaminophen is safe when used as directed," said Edwin K ... Read more

Health Tip: Pain Relievers Aren't for Everyone

Posted 19 Jul 2011 by Drugs.com

-- Over-the-counter pain relievers can be a quick and easy option to manage pain, but they may not safe for everyone. The American Academy of Family Physicians says you should speak with a doctor before you take painkillers including acetaminophen, aspirin or ibuprofen if: You have a known allergy to a pain reliever. You drink three or more alcoholic beverages each day. You have ulcers or bleeding in the intestines or stomach. You have kidney, liver or heart disease. You have a bleeding disorder or take a medication to thin the blood. Read more

FDA Medwatch Alert: Tylenol Extra Strength Caplets, 225 count bottles: Recall - Uncharacteristic Odor

Posted 30 Jun 2011 by Drugs.com

ISSUE: McNeil Consumer Healthcare is recalling one product lot of Tylenol Extra Strength Caplets, 225 count bottles, distributed in the U.S. The recall stems from a small number of odor reports, including musty, moldy odor. The uncharacteristic musty, moldy odor has been linked to the presence of trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA). While not considered to be toxic, TBA can generate an offensive odor and has been associated with temporary and non-serious gastrointestinal symptoms. BACKGROUND: The Tylenol lot ABA619 - which includes 60,912 bottles - was manufactured in February, 2009. The product lot number for the recalled product can be found on the side of the bottle label. RECOMMENDATION: Consumers who purchased product from the lot included in this recall should stop using the product and contact McNeil Consumer Healthcare, either at www.tylenol.com or ... Read more