Hazardous Amounts of Selenium Found in Supplements: FDA
Hazardous amounts of the trace mineral selenium have been found in samples of the dietary supplements "Total Body Formula" and "Total Body Mega Formula," the U.S. Food and Drug Administration warned Wednesday.
The agency said it has 43 reports from nine states of serious adverse reactions among people who took the supplements, which have been recalled by the distributor.
Last month, the FDA warned consumers not to buy or use tropical orange or peach nectar flavors of "Total Body Formula," or the orange/tangerine flavor of "Total Body Mega Formula." The agency cited adverse reactions occurring within 10 days of the products' use, including hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails, and fatigue.
Selenium, an immune-system boosting mineral, is needed in very small amounts. But the FDA said its analysis found that the supplements contained up to 200 times the amount per serving that had been indicated on the products' labeling.
The agency said it is investigating how the excess selenium wound up in the products, which are distributed by Atlanta-based Total Body Essential Nutrition. The supplements were distributed nationwide in 32-ounce plastic bottles.
Consumers should immediately stop using the products and throw the remainder away, the FDA said.
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Elevated Lung Cancer Cases in Users of Inhaled Insulin
Patients who used the inhaled insulin product Exubera had an elevated number of lung cancer cases, drug maker Pfizer Inc. disclosed Wednesday. The lung cancer cases were discovered in an analysis of clinical trials and post-approval reports to Pfizer and the U.S. Food and Drug Administration, Bloomberg news reported.
All the patients who developed lung cancer "had a prior history of cigarette smoking" and "there were too few cases to determine whether the development of lung cancer is related to the use of Exubera," Pfizer said in a statement.
Last October, Pfizer stopped selling Exubera, which failed to catch on with patients and doctors due to its cost and cumbersome delivery device, Bloomberg reported.
In addition, the inhaled insulin seemed to decrease lung function, apparently due to the way the insulin was delivered into the lungs, Forbes reported at the time.
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6,700 Children Hospitalized for Neglect, Abuse in 2005
Of the 6,700 children in the United States hospitalized for neglect or physical abuse in 2005, more than 200 died and all the children who died were under age 5, according to the latest News and Numbers from the federal Agency for Healthcare Research and Quality.
The analysis of hospital data showed that children under age 5 accounted for 80 percent of all those under age 18 who were hospitalized for abuse or neglect. The average hospital stay for these children cost $14,800, which is 75 percent more than the cost of an average child's hospital stay. The total 2005 hospital care cost for children who suffered physical, sexual or emotional abuse or neglect was nearly $100 million.
Other findings from the analysis:
- Children hospitalized due to abuse or neglect were seven times more likely to die in the hospital than children admitted for other reasons.
- More than one-third of children hospitalized for physical abuse had head injuries, 26 percent had bruises, 21 percent had bleeding behind the eye, 20 percent had epileptic convulsions, and 18 percent had broken legs or feet.
- Children from the poorest communities accounted for nearly 36 percent of hospitalizations for abuse or neglect, while 14 percent were from wealthy communities.
- Nearly 71 percent of these hospitals stays were billed to Medicaid and 21 percent to private insurers. About 5 percent were uninsured and the rest were charged to other government payers.
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U.S. Officials Seize Unapproved Impotence Drugs
U.S. authorities have seized more than 14,000 dosage units of unapproved drugs marketed as natural supplements to treat erectile dysfunction, the Food and Drug Administration said Wednesday.
The seized products, worth more than $100,000, included Shangai Regular, Shangai Ultra, Super Shangai, Naturale Super Plus and Lady Shangai. The FDA said they contained undeclared active ingredients found in approved prescription drugs for erectile dysfunction.
The use of these seized products could cause serious side effects and they may interact in dangerous ways with other medications being taken by a consumer. The products, which originated in China, are packaged and distributed by Shangai Distributors of Coamo, Puerto Rico.
Consumers who've bought any of these products should stop using them and consult their health-care providers if they've experienced any problems they believe may be related to the use of the products, the FDA said.
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U.S. Surgeons Perform 6 Simultaneous Kidney Transplants
In what's believed to be the first operation of its kind, Johns Hopkins surgeons transplanted six kidneys simultaneously, hospital officials announced Tuesday. The 10-hour surgeries on Saturday required six operating rooms and nine surgical teams, the Associated Press reported.
"All 12 (donor and transplant) patients are doing great, the kidneys are working well," said Dr. Robert Montgomery, director of Hopkins' transplant center and head of the transplant team.
The transplants were made possible when a donor who was willing to donate a kidney to anyone was found to be a match for one of the transplant candidates. The other five candidates each had a willing donor whose kidney wasn't a match for their particular relative or friend, but was a match for one of the other candidates, the AP reported.
The donors and recipients were matched using a living-donor system developed at Johns Hopkins.
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THC/Alcohol Combination Kills Brain Cells: Study
A combination of THC -- the active ingredient in marijuana -- and alcohol caused widespread nerve cell death in the brains of rats, says a German study.
Researchers injected THC, a synthetic form of THC, ethanol, the anticonvulsant drug MK-801, and phenobarbital to rats 1 to 14 days old, United Press International reported.
When administered alone, neither THC nor synthetic THC caused cell death. But both did cause cell death when given with lower-than-toxic amounts of ethanol. The researchers also found that THC increased the neurotoxic effect of MK-801 and phenobarbital.
"Nerounal degeneration became disseminated and very severe when THC was combined with a mildly toxic ethanol dose," the researchers said in a statement. The study was published in the journal Annals of Neurology.
The researchers said the combined effect of THC and alcohol on the developing brain requires further investigation, UPI reported.
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Pre-Eclampsia May Increase Child's Heart Disease Risk
Children born to mothers who develop pre-eclampsia during pregnancy may have an increased risk of developing cardiovascular disease later in life, according to researchers at the University of Cambridge in Great Britain.
Pre-eclampsia can reduce the amount of oxygen a fetus receives. This may impair the growth of the baby's cardiovascular, metabolic and endocrine systems, said the researchers, who studied pregnancies at high altitude (where oxygen is restricted) and conducted tests on pregnant animals, BBC News reported.
Their findings were to be presented at a meeting of the Society for Endocrinology.
"We have known for a while that changes in maternal nutrition can affect fetal development and influence disease susceptibility later in life, but relatively little work has investigated how low oxygen levels in the womb may affect infant development," said lead researcher Dr. Dino Giussani, BBC News reported.
"Our research shows that changes to the amount of oxygen available in the womb can have a profound influence on the development of the fetus in both the short- and long-term, and trigger an early origin of heart disease."
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