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.

FDA Panel to Vote on Drugs Said to Prevent Prostate Cancer

A U.S. Food and Drug Administration advisory panel is expected to decide Wednesday whether to approve two drugs for the prevention of prostate cancer, the third highest cancer killer of men. Avodart and Proscar, manufactured by GlaxoSmithKline and Merck, respectively, are already approved to treat enlarged prostates. The drug makers say their research shows the drugs also lower the risk of prostate cancer by more than 20 percent. FDA regulators have several concerns, the Associated Press reported. For one thing, black men, who are at high risk for the disease, were underrepresented in the clinical trials.

"The applicability to African-American men is not known due to marked under-representation," the FDA's online review stated. Blacks made up just 4 percent of Merck's patients and only 2 percent of Glaxo's patients, according to the AP. The panel of outside experts assembled by the FDA is also likely to discuss the overall value of preventing low-grade tumors. According to the FDA, more than three-quarters of the tumors the drugs prevent are slow-growing, meaning they are non-aggressive and probably not life-threatening for anyone with a life expectancy of less than 20 years.

If the tumors aren't aggressive, Glaxo has said they often involve unnecessary treatment and biopsies, or surgical procedures, to diagnose cancer, that pose risks of their own. Also, slightly more aggressive tumors were seen in men taking Avodart and Proscar, compared with those taking placebo pills, according to the FDA. But the pharamaceutical companies say the drugs simply make those tumors easier to detect because they shrink the prostate. The U.S. National Cancer Institute estimates that 217,730 men will be diagnosed with prostate cancer this year and 32,050 men will die of it.