FDA Approves New Drug for Bacterial Vaginosis
Tindamax, the first new oral treatment for bacterial vaginosis in a decade, has been approved by the U.S. Food and Drug Administration, Mission Pharmacal of San Antonio, Texas announced Tuesday.
The new drug provides a shorter course of treatment, with fewer doses per day, than metronidazole, the current standard of care, the company said. Patients take two tablets (a total of one gram) of Tindamax once a day for five days or four tablets (two grams) once daily for two days. Metronidazole is taken twice-daily for seven days.
The FDA approval is supported by a study of 235 women with bacterial vaginosis that reported a cure rate of 27.4 percent for women who took two grams daily for two days and a cure rate of 36.8 percent for women who took one gram daily for five days. Women who took a placebo had a cure rate of 5.1 percent.
Side effects included nausea, anorexia, abdominal discomfort, vomiting, constipation, diarrhea, weakness/fatigue, dizziness and headache.
Bacterial vaginosis, which affects about a third of women in the United States, is the most common vaginal infection among women of childbearing age. The infection often causes no symptoms. Left untreated, it can increase a woman's susceptibility to other sexually transmitted diseases and the risk of pelvic inflammatory disease and cervicitis.
Tindamax is also approved to treat trichomoniasis, the most common curable sexually transmitted disease in the United States.
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High-Fat, High-Fructose Diet Can Spur Fatty Liver Disease
Mice that ate a high-fat, high-fructose diet -- similar to what many Americans eat -- quickly developed fatty liver disease and signs of diabetes, according to a Saint Louis University study presented at the Digestive Diseases Week meeting in Washington, D.C.
Fatty liver disease can lead to cirrhosis and death.
The diet offered to the mice contained 40 percent fat (about what would be found in a typical McDonald's meal) and plenty of high-fructose corn syrup, a sweetener used in sodas and some fruit drinks. The researchers also restricted the rodent's amount of activity.
"We had a feeling we'd see evidence of fatty liver disease by the end of the (16-week) study," study author Dr. Brent Tetri, associate professor of internal medicine at the university's Liver Center, said in a prepared statement. "But we were surprised to find how severe the damage was and how quickly it occurred. It took only four weeks for liver enzymes to increase and for glucose intolerance -- the beginning of type 2 diabetes -- to begin."
These findings in mice are a warning for humans, he said.
"A high-fat and sugar sweetened diet compounded by sedentary lifestyle will have severe repercussions for your liver and other vital organs," Tetri said. "Fatty liver disease now affects about one of every eight children in this country. The good news is that it is somewhat reversible -- but for some it will take major changes in diet and lifestyle."
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NIH Ends Chimpanzee Breeding
The U.S. National Institutes of Health (NIH) announced this week that it is permanently ending the breeding of government-owned chimpanzees for research.
The move was applauded by the Humane Society of the United States (HSUS).
"This decision is a huge step towards a day when chimpanzees are no longer used in invasive biomedical research and testing," Kathleen Conlee, director of program management for animal research issues for the society, said in a prepared statement. "This will spare some chimpanzees a life of up to 60 years in a laboratory. While it doesn't help chimpanzees already living in laboratories, it is a monumental decision."
The NIH's National Center for Research Resources said that a lack of money to support the breeding of more chimpanzees was the reason for the decision. Currently, the U.S. government spends $20 million to $25 million a year on the care of chimpanzees in laboratories. A lifetime of care for one chimpanzee costs $300,000 to $500,000.
Of the estimated 1,200 chimpanzees in nine laboratories throughout the U.S., about 500 are government owned or supported. About 90 chimpanzees formerly used in research are now retired and live in a federal sanctuary.
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FDA Orders Testing of Chinese-Made Toothpaste
Testing will be done on samples of all Chinese-made toothpaste imported into the United States, the U.S. Food and Drug Administration said Wednesday.
The FDA's move comes in response to news that some brands of Chinese-made toothpaste sold in Panama, the Dominican Republic and Australia may contain diethylene glycol, a poisonous ingredient used in antifreeze, The New York Times reported. Some of the toothpaste was marketed for children.
Tens of thousands of tubes of toothpaste have been seized by health officials in the Dominican Republic and Panama. Tainted toothpaste in Panama contained diethylene glycol concentrations of 1.7 percent to 4.6 percent.
FDA spokesman Doug Arbesfeld said there is no evidence that any tainted toothpaste is in the United States, but the FDA decided to order testing of Chinese-made toothpaste as a precaution, The Times reported.
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Gay Men Still Banned for Life from Donating Blood: FDA
Even though it's been criticized as "medically and scientifically unwarranted," the U.S. Food and Drug Administration will continue its policy of banning gay men for life from donating blood.
The policy -- first introduced in 1983 as a way to prevent the spread of HIV through transfusions -- was reiterated on the FDA Web site Wednesday, the Associated Press reported. HIV is the virus that causes AIDS.
The policy restatement comes more than a year after the American Red Cross and two other blood groups -- America's Blood Centers and the international blood association AABB -- criticized the ban and suggested it be replaced with a one-year deferral after a man has sexual contact with another man.
The groups pointed out to the FDA that new and improved tests can detect HIV-positive blood donors within 10 to 21 days of infection, which means the lifetime ban on gay men isn't necessary, the AP reported.
However, the FDA contends that current HIV tests may be highly accurate, but cannot detect HIV 100 percent of the time. In the document posted Wednesday, the agency said it would change the policy if it receives data showing that doing so wouldn't pose a "significant and preventable risk" to blood recipients.
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NIH Study Will Compare Children's Seizure Drugs
A study to determine which drug -- Valium or Ativan -- is best to treat children with life-threatening status epilepticus seizures was announced Wednesday by the U.S. National Institutes of Health, the Associated Press reported.
If not treated properly, status epilepticus (a series of continuous, severe seizures) can lead to brain damage or death. These events occur in about 60,000 people in the U.S. each year, mostly children. Head injury, a central nervous system infection, high fever, and low blood sugar are among the risk factors for status epilepticus.
This study, funded by the NIH and to be conducted in 11 hospitals across the country, is unusual in that children with status epilepticus will be automatically enrolled in the trial when they're brought to the hospitals' emergency rooms. Doctors will not seek parents' permission at that point, the AP reported.
This is because time is critical when treating these patients. A computer will randomly assign the children to receive either Valium or Ativan within five minutes after they arrive in the emergency room.
Only after children's seizures have been brought under control will parents be told about the study and asked if they'll permit their child to remain in the study and receive additional medical monitoring, the AP reported.
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