FDA Urged to Ease Patient Restrictions for Heart Ablation Trials
Experts say the U.S. Food and Drug Administration should ease restrictions on which patients with a common heart condition called atrial fibrillation can be enrolled in clinical trials of devices used to provide a treatment called ablation, The New York Times reported.
That was one of the suggestions offered Thursday by a panel of experts at a daylong meeting on clinical trials for treatments of atrial fibrillation, a nonfatal but distressing condition in which electrical shortcircuits in the upper chambers of the heart cause rapid, erratic contraction. The condition affects about 2.2 million Americans.
Ablation involves burning or freezing certain areas of the atrial muscle to either eliminate the source of the irregular pulses or to block the pathways they travel. This common method of treatment is used when drug therapy fails or causes intolerable side effects, the Times reported.
"We have to be more flexible," Dr. Bram Zuckerman, director of the FDA's cardiovascular devices division, said in response to the expert panel's remarks about rapidly evolving technology for treating atrial fibrillation.
Simplicity Recalls Cribs Linked to Deaths of 3 Babies
About one million Chinese-made cribs have been voluntarily recalled by Simplicity Inc. because problems with the drop rail can create a dangerous gap that poses a risk of suffocation and entrapment. The cribs have been linked to the deaths of at least three children in the United States, the federal Consumer Product Safety Commission said Friday.
The three babies -- ages 6 months, 9 months, and 1 year -- died in cribs where the drop rail was installed upside down due to poor hardware and crib design, the Chicago Tribune reported. The CPSC said it's also aware of seven infant entrapments and 55 incidents in these cribs.
The recalled Simplicity crib models include: Aspen 3 in 1; Aspen 4 in 1; Nursery-in-a Box; Crib N Changer Combo; and the Chelsea and Pooh 4 in 1. The recall also includes these Simplicity cribs sold with the Graco logo: Aspen 3 in 1; Ultra 3 in 1; Ultra 4 in 1; Ultra 5 in 1; Whitney; and the Trio.
This is the largest crib recall since the CPSC was created in the 1970s, the Tribune reported. For more information, contact Simplicity toll-free at (888) 593-9274.
Colic Remedy May Contain Parasite
Parents should not give their babies a liquid herbal supplement called Baby's Bliss Gripe Water -- sold as a remedy for colic and teething pain -- because it may contain a parasite that can cause diarrhea and intestinal infections, the U.S. Food and Drug Administration said Thursday.
Tests on several bottles of apple-flavored Baby's Bliss Gripe Water tested positive for Cryptosporidium, which may have sickened a 6-week-old baby in Minnesota. To date, that baby is the only one with a reported illness possibly linked to the supplement, the Associated Press reported.
The product is distributed in the United States by MOM Enterprises of San Rafael, Calif. The company has recalled about 17,600 bottles sold through the Internet and at retail stores across the country. The recall covers 4-ounce bottles with the code 26952V and an expiry date of October 2008. Consumers can call the company at 877-457-4955 for more information.
The FDA advised parents to throw out any of the product they have and to consult a pediatrician if the product was consumed by a child who seems sick, the AP reported.
California Officials Warn of Lead in Lunch Boxes
Concerns about the presence of lead prompted California officials Thursday to warn people not to use about 56,000 made-in-China lunch boxes distributed by the state as part of a program to encourage people to eat more fruits and vegetables.
Tests detected elevated levels of lead in three of the green canvas boxes, which were distributed at health fairs and other events, the Associated Press reported. The lunch boxes carry a logo that says "eat fruits and vegetables and be active."
Parents whose children used the lunch boxes should consult with a doctor to determine if the children should be tested for exposure to lead, said Mark Horton, director of California's Department of Public Health.
A swab test conducted in July by the Sacramento County Health Department indicated that the lunch boxes contained lead, Horton said. Several weeks of more sophisticated testing through the state Department of Toxic Substance Control confirmed that there was lead in multiple parts of the box, the AP reported.
Mattel Apologizes to China Over Toy Recalls
In an extraordinary move, U.S. toy giant Mattel Inc. on Friday issued a public apology to China over the recall of Chinese-made toys. Mattel said it was to blame for design flaws in the toys and said its recalls of lead-tainted toys were more extensive than necessary.
"Our reputation has been damaged lately by these recalls," Thomas A. Dombrowski, Mattel's vice president for worldwide operations, said in a meeting with Chinese product safety chief Li Changjiang, the Associated Press reported.
"And Mattel takes full responsibility for these recalls and apologizes personally to you, and the Chinese people, and all of our customers who received the toys," Dombrowski said.
In recent months, concerns about lead paint and tiny magnets that could be swallowed prompted Mattel to order three high-profile recalls of more than 21 million Chinese-made toys.
Dombrowski said the "vast majority of those products that were recalled were the result of a design flaw in Mattel's design, not through a manufacturing flaw in China's manufacturers," the AP reported. Only a small percentage of the recalled toys were lead-tainted, he noted.
Pro Golf Announces Anti-Doping Policy
Following the lead of other major sports, professional golf's top organizations have announced an anti-doping policy that will take effect in 2008. The policy includes a list of banned substances including narcotics, stimulants, anabolic steroids, hormones, beta blockers and masking agents.
The organizations involved in the policy are the: PGA Tour; European Tour; U.S. Golf Association; Royal & Ancient Golf Club; Augusta National Golf Club; PGA of America; and the LPGA Tour, the Associated Press reported.
The policy will be coordinated so that a punishment imposed on a player for a doping infraction will be recognized and enforced worldwide.
Golf officials say there is no evidence of golfers taking performance-enhancing drugs, but they'd been facing increasing pressure to develop an anti-doping policy, AP reported.