Health highlights: March 28, 2011
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Mislabeled Citalopram and Finasteride Recalled
Certain batches of Citalopram and Finasteride are being recalled in the United States because they may have been incorrectly labeled by a third-party manufacturer, says Pfizer Inc.’s Greenstone LLC unit.
Citalopram is an antidepressant and Finasteride is used to treat benign prostatic hyperplasia (enlarged prostate). Some bottles of Citalopram may be labeled as Finasteride and vice versa, according to the U.S. Food and Drug Administration.
The voluntary recall includes Citalopram 10 mg tablets (100-count bottle) and Finasteride 5 mg tablets (90-count bottle) with lot number FI0510058-A on the label.
Consumers with these products should return them and patients who believe they may have taken the wrong medication should contact a doctor as soon as possible, the FDA said.
FDA Panel Examines Food Dyes and Hyperactivity in Children
There may some truth to the widely held belief that synthetic food dyes can cause hyperactivity in children, suggests a U.S. Food and Drug Administration memo released this week.
The document says children with attention deficit hyperactivity disorder (ADHD) may have a “unique tolerance” to artificial food colorings. The memo also said the dyes haven’t been proven to cause hyperactivity in most children, nor have the man-made colorings been found to contain “any inherent neurotoxic properties,” ABC News reported.
The research summary was distributed ahead of a two-day hearing in which an FDA advisory committee will examine any possible links between artificial food dyes and hyperactivity in children. The committee will recommend whether the FDA should take steps to protect consumers.
The FDA memo was prepared after the Center for Science in the Public Interest petitioned the agency to revoke approvals for eight certified synthetic food dyes: FD&C Blue 1 and 2; FD&C Green 3; Orange B; FD&C Red 3; FD&C Red 40; FD&C Yellow 5 and 6, ABC News reported.
New Drug for Advanced Melanoma Approved by FDA
A new injectable drug touted as the first to prolong the lives of patients with melanoma has been approved by the U.S. Food and Drug Administration.
The immune system-stimulating drug Yervoy (ipilimumab) from Bristol-Myers Squibb Co. was approved to treat patients with late-stage or metastatic melanoma. Currently only two other drugs have FDA approval for treatment of advanced melanoma and neither of them has been shown to significantly extend patients’ lives, the Associated Press reported.
The FDA’s approval of Yervoy was based on a Bristol-Myers study of 676 patients with advanced, inoperable melanoma who had failed to respond to two other treatments. They were randomly assigned to receive either: Yervoy alone, Yervoy and another immune-stimulating treatment; or the other immune-stimulating treatment alone.
Patients who received Yervoy alone lived an average of 10 months, compared to six months for those in the other groups. However, some of the patients who received the new drug survived longer than six years. This suggests that the drug could be targeted at patients most likely to respond, the AP reported.
While 85 percent of patients showed little response to Yervoy, the response rate should improve as the drug is used earlier in the disease process, according to researchers.
“Clearly this is not a home run, but it’s a solid base hit,” Tim Turnham, director of the Melanoma Research Foundation, told the AP. “And because we see other things in the pipeline, we think this the first in a series of important new therapies for melanoma.”
“I think the direction this is headed is toward intervening earlier, when patients’ immune systems are still intact, rather than waiting until they are so sick,” Dr. Anna Pavlick, director of the New York University’s melanoma program, told the AP.
She is a spokeswoman for the Skin Cancer Foundation, which helped conduct several early-stage trials of Yervoy.
Melanoma is the most deadly type of skin cancer and is the fastest growing type of cancer in the U.S. in terms of new diagnoses, the AP reported. Last year, about 68,000 people in the U.S. were diagnosed with melanoma and about 8,700 people died from the disease, says the American Cancer Society.
Copyright © 2011 HealthDay. All rights reserved.