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Know What's in Your Child's Medications, FDA Warns

Posted 17 Mar 2013 by Drugs.com

SUNDAY, March 17 – It's the time of year when cold season and allergy season overlap, and parents need to know the active ingredients in the medicines they give their children for these conditions, the U.S. Food and Drug Administration warns. Taking more than one medicine at a time could cause serious health problems if the drugs have the same active ingredient, which is the component that makes the medicine effective against a particular condition. For over-the-counter products, active ingredients are listed first on a medicine's Drug Facts label. For prescription medicines, active ingredients are listed in a patient package insert or consumer information sheet provided by the pharmacist, the FDA said. Many medicines have just one active ingredient. But combination medicines – such as those for allergy, cough or fever and congestion – may have more than one. Antihistamine is an ... Read more

Doubling Up on Cold, Flu Remedies May Harm Liver

Posted 30 Jan 2013 by Drugs.com

WEDNESDAY, Jan. 30 – Taking too much acetaminophen, an active ingredient in many commonly used drugs for fever and pain relief, including Tylenol, can cause liver damage, experts at the U.S. Food and Drug Administration warn. People suffering from a cold or the flu may be tempted to take a combination of medicines to treat several symptoms. Used correctly, acetaminophen can be safe and effective. More than 600 prescription and over-the-counter medications contain acetaminophen, however, and doubling up on these remedies can be dangerous, the FDA cautioned. Complicating matters, signs of an acetaminophen overdose may not become apparent for days. "If you're taking more than one medicine at a time, you may be putting yourself at risk for liver damage," Dr. Fathia Gibril, a supervisory medical officer at the FDA, said in an agency news release. Over-the-counter medications are used by 70 ... Read more

When Prescription Drugs Go OTC, Ads Talk Less of Harms: Study

Posted 11 Sep 2012 by Drugs.com

TUESDAY, Sept. 11 – When prescription drugs become available over-the-counter, advertisements for the medications are far less likely to tell consumers about the potential harms and side effects, new research finds. The reason for it, experts say, likely has to do with which federal agency regulates the marketing materials for each type of drug. The U.S. Food and Drug Administration (FDA) regulates ads for prescription drugs, while ads for over-the-counter drugs are regulated by the U.S. Federal Trade Commission (FTC). The FTC has much less stringent standards than the FDA for what manufacturers have to reveal about products in their marketing materials, the researchers noted. The FDA requires prescription drug advertising to provide consumers with a "fair balance" of risks and benefits – for drug ads, that often means rattling off a lengthy list of potential side effects. The FTC, on ... Read more

Tylenol Overdose Can Be Deadly for a Child

Posted 10 Jun 2012 by Drugs.com

FRIDAY, June 8 – Overdoses of the pain and fever drug acetaminophen (brand name Tylenol) are a leading cause of acute liver failure in children, and more public education is needed to warn parents and others of this danger, experts say. Acetaminophen is a widely available over-the-counter medication, but repeated doses above the recommended level, or overdoses due to errors or intentional consumption, can lead to acute liver failure and even death in children, according to Dr. Rod Lim, of the Children's Hospital at the London Health Sciences Center in Ontario, Canada, and colleagues. Writing in the June 4 issue of the Canadian Medical Association Journal, they cite a case study of parents who mistakenly gave their 22-day-old baby boy too much acetaminophen after a circumcision. The mistake was discovered, and the child recovered after receiving intravenous treatment with ... Read more

Many Americans Taking Too Much Acetaminophen

Posted 2 Jun 2012 by Drugs.com

FRIDAY, June 1 – Many U.S. adults are at risk for overdosing on over-the-counter pain relievers containing acetaminophen, according to a new study. Acetaminophen (Tylenol) is the most commonly used over-the-counter pain medication in the United States, and acetaminophen overdose is the leading cause of acute liver failure, according to researchers from Northwestern University in Evanston, Ill.. The researchers interviewed 500 adult patients at outpatient general medicine clinics in Atlanta and Chicago. More than half had used acetaminophen in the past six months and 19 percent said they were heavy users, which means they took acetaminophen every day or a couple of times a week. The study authors then assessed whether the patients understood the recommended dosage of acetaminophen products and if they were able to take them safely. The results showed that nearly a quarter of the ... Read more

Patients May Receive Too Much Acetaminophen in Hospital

Posted 23 May 2012 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