Health Highlights: May 1, 2008
Here are some of the latest health and medical news developments, compiled by editors of HealthDay:
AED Maker Signs Decree Temporarily Barring Sales
A consent decree of permanent injunction related to automatic external defibrillators (AEDs) made by Physio-Control, Inc. has been signed by the company, its parent firm Medtronic Inc., and two top executives, the U.S. Food and Drug Administration says.
AED's are portable devices used to restore normal heart rhythm in people who have had a heart attack.
The consent decree prohibits the manufacture, distribution, and export of specified AEDs from Physio-Control's facility in Redmond, Wash. until the devices and facility have been shown to be in compliance with the FDA's current Good Manufacturing Practice requirements.
FDA inspections of the facility in October 2006 and January 2006 identified a number of deficiencies, including failure to establish and maintain adequate procedures for validating the device design, and failure to establish adequate procedures for implementing corrective and preventive actions.
Previous FDA inspections in 2000, 2003 and 2005 showed similar violations. The FDA issued warning letters after the 2000 and 2005 inspections.
These problems don't necessarily mean that AEDs produced by the company and currently on the market will harm patients, the FDA said. The corrections it's seeking are meant to ensure the continued availability of safe, effective and reliable products, the agency said.
Hazardous Chromium Levels Found in Total Body Products
Final tests of certain flavors of Total Body Formula and Total Body Mega Formula dietary supplements detected hazardous amounts of chromium, in addition to high levels of selenium, the U.S. Food and Drug Administration said Thursday.
In early April, the FDA reported that hazardous amounts of selenium were found in samples of the tropical orange and peach nectar flavors of Total Body Formula and in the orange/tangerine flavor of Total Body Mega Formula. Additional tests revealed that the products also contained chromium in amounts up to 17 times higher than the recommended adult daily intake.
Excessive levels of chromium can cause fatigue, muscle cramps, hyperactivity, hypoglycemia, renal failure, liver toxicity, and interfere with certain medications. To date, there have been 195 confirmed cases of adverse reactions among users, according to the Centers for Disease Control and Prevention.
The products have been recalled and the FDA is investigating how excessive amounts of chromium and selenium got into the products. Anyone who has used the products and has had an adverse reaction should consult their doctor, the FDA said.
Viral Outbreak in China Likely to Increase
An outbreak of an intestinal virus that's infected 1,884 children and killed 20 in China is likely to widen and claim more lives, Agence France-Presse cited Chinese officials as saying.
The outbreak of enterovirus 71 (EV71) in Fuyang city in Anhui province is believed to have started in early March, but reports of the epidemic only emerged on Monday.
"We estimate that the hand, foot and mouth disease (caused by EV71) in Fuyang city will continue for some time, the number of cases will continue to increase, and serious and fatal cases might still continue to happen," the Chinese Health Ministry said in a statement on its Web site, AFP reported.
In an attempt to calm fears, the health ministry said now that cases are now being discovered and treated in their early stages, "the successful treatment rate of the serious cases will markedly increase."
Earlier this week, the World Health Organization expressed concerns about the outbreak.
"Although enteroviruses infecting humans are found worldwide and enterovirus 71 has been reported in China over recent years, we believe the situation is still of concern, especially because of the current high reported case fatality rate compared to previous years," Dr. Cris Tunon, a senior WHO official, said in an email statement to AFP.
U.S. Breast-Feeding Rate Hits 20-Year High
More than three-quarters of new mothers (77 percent) are breast-feeding their infants, the highest rate in at least 20 years, the U.S. Centers for Disease Control and Prevention said in report issued Wednesday.
Experts cited by the Associated Press attributed the rise to public education campaigns stressing that breast milk better protects infants against disease and childhood obesity than formula.
The percentage of black infants who are breast-fed rose most, to 65 percent from 36 percent in 1993-1994, the report said. Among whites, the rate rose to 79 percent from 62 percent, and among Mexican-Americans, the figure rose to 80 percent from 67 percent, the wire service said.
Breast-feeding rates were lowest among women who weren't married, were poor, rural, younger than 20, and had no greater than a high school education.
FDA Warns Merck to Correct Vaccine Plant Issues
Merck & Co. has been warned by the U.S. Food and Drug Administration to clean up problems cited at the drug maker's West Point, Pa., vaccine plant, the Philadelphia Inquirer reported Wednesday.
The agency's warning, posted on its Web site, addressed 45 "areas of concern" at the plant, including unwanted fibers found on the stoppers of vaccine vials. The company has 15 days to inform the FDA of its plans to correct the issues, said the newspaper, which first reported the FDA's inspection findings last week.
The plant produces the popular vaccine, Gardasil, designed to protect against cervical cancer, according to the Associated Press. The facility also makes a number of children's vaccines.
Last year, Merck recalled 1.2 million vaccine doses produced at the plant because of a sterility problem, the wire service said.
A Merck spokeswoman told the Inquirer that the company was working to correct the issues noted in the FDA report. She added that the problems were caught by Merck workers "before contaminated vaccines were released to the public," the newspaper said.
1 in 5 Returning Soldiers Reports Mental Illness: Survey
Almost 20 percent of American soldiers returning from Iraq and Afghanistan are reporting symptoms of mental illnesses including post-traumatic stress and major depression, the Bloomberg news service says, citing a new survey sponsored by the American Psychiatric Association.
Most of the returning vets said they were reluctant to seek psychological counseling, fearing it would jeopardize their careers, Bloomberg said.
The survey, conducted by Harris Interactive and involving 191 members of the military and their spouses, took place from March 5 to March 18.
Mental health conditions -- including lost productivity and suicides -- have cost the nation an estimated $6.2 billion in the two years after deployment, according to a recent Rand Corp. analysis cited by the news service.
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