FDA Panels to Weigh Dosing Labels for Kids' OTC Fever Relievers

Two U.S. Food and Drug Administration advisory committees plan to meet Tuesday and Wednesday to decide whether to recommend that the dosing instructions on the labels of medicines containing acetaminophen need to be fine-tuned to protect children under the age of 2 against possible liver failure and even death. Currently, the labels of such fever-reducing medications, which include Children's Tylenol, have dosing instructions for children aged 2 and up. For kids under 2, the labels simply tell parents to "ask a doctor." The American Academy of Pediatrics (AAP) and drug manufacturers are both strongly in favor of giving parents the additional dosing information.

"If we give parents better information, they will be able to give enough of the medicine to work well, at the same time minimizing the side effects," said Dr. Daniel Frattarelli, a pediatrician in Dearborn, Mich. who chairs the academy's drug committee and who plans to testify before a joint, two-day meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee. "Parents want to do the right thing for their children," he said. "We as a medical community have to give them that information so they are able to do this." Although the evidence shows that acetaminophen is safe for young children, parents have to be careful with it, pediatricians noted. Giving too much can be toxic to the liver, causing poisoning and even liver failure.

In 2010, there were 270,000 reported overdoses of acetaminophen, according to the American Association of Poison Control Centers. Dosing errors involving children's acetaminophen products accounted for almost 7,500 cases nearly 3 percent. In an ideal world, the parents of infants and toddlers would still consult with their pediatrician or pharmacist to get the proper medication dosing, said Dr. William Basco, director of general pediatrics at the Medical University of South Carolina. But the reality is that many parents aren't doing that and are instead guessing about proper dosing. "There is no benefit to having parents guess at the right dose," Basco said.

Keeping Holiday Drinking in Check May Counter Cancer

Though holiday partying often includes alcohol consumption, cancer experts are urging partiers to partake moderately. "Research shows that drinking even a small amount of alcohol increases your chances of developing cancer, including oral cancer, breast cancer and liver cancer," Clare McKindley, clinical dietician in the Cancer Prevention Center at the University of Texas M.D. Anderson Cancer Center, said in a news release from the center.

"Researchers are still trying to learn more about how alcohol links to cancer," she added. "But convincing evidence does support the fact that heavy drinking damages cells and increases the risk for cancer development." To reduce risk, experts say, drinkers can do a number of things. First, stick to the recommended serving size. A drink is defined as 12 ounces of beer, 5 ounces of wine or 1.5 ounces of liquor. Women should have no more than one drink a day and men should have no more than two drinks a day, according to the U.S. National Cancer Institute.

Try to avoid high-calorie drinks. Many popular alcoholic drinks are loaded with calories, especially those mixed with soda, fruit juice or cream. A one-cup serving of eggnog, a holiday staple, has about 340 calories. Being overweight or obese is also associated with an increased risk for cancer. Researchers believe that it is the ethanol or alcohol in beer, wine and liquor that increases cancer risk. Check the ethanol percentage numbers on bottle labels and stay away from 100-proof liquor.

Adding Third Drug May Improve Hepatitis C Treatment

The current two-drug standard treatment for the potentially lethal hepatitis C could be rendered nearly twice as effective if doctors added in a third antiviral medication called boceprevir, new research suggests. The finding might help the estimated 170 million people worldwide who are infected with this particular type of hepatitis C (genotype 1), the study authors say, given that the liver infection is difficult to treat. The study, funded by Merck, the maker of boceprevir, was reported online Aug. 8 in The Lancet. According to the researchers, led by Dr. Paul Y. Kwo of Indiana University School of Medicine in Indianapolis, the standard two-drug treatment of pegylated interferon plus ribavirin prompts the desired virological response in less than half of patients.

Searching for a way to improve these outcomes, the Indiana team launched a two-phase trial involving 520 hepatitis C patients in 67 sites across the United States, Canada and Europe. Patients received one of several drug cocktails of various strengths for upwards of 48 weeks. Some of the drug combinations included boceprevir, while some did not. Irrespective of other factors including attempts to reduce the length of treatment or the amount of standard medications given to patients adding boceprevir to the mix appeared to consistently boost viral response, Kwo and his colleagues reported.

However, the effectiveness of the three-drug regimen was undercut somewhat when the team lowered the amount of ribavirin the patients received. In a news release from the journal, the team concluded that, "boceprevir, in combination with pegylated interferon and ribavirin, achieves high (virological response) rates with 28 weeks of therapy in most patients, and is safe and effective for use up to 48 weeks in the few patients who benefit from longer duration of therapy." They also noted "increased response rates in difficult-to-treat groups, including black participants and those with cirrhosis."