Contact Lens Eye Solution Pulled from Market; FDA Says to Discontinue Use
Increased incidences of a rare but stubborn eye infection have caused the U.S. Food and Drug Administration to alert the public to discontinue using a solution used to clean contact lenses.
The Associated Press reports that AMO Complete Moisture Plus Multi-Purpose Solution, used for cleaning and storing soft contact lenses, had been immediately and voluntarily recalled by its manufacturer, Advanced Medical Optics Inc., of Santa Ana Calif.
The infection in question is Acanthamoeba keratitis, which is caused by an amoeba, the A.P. quotes Michael Beach, team leader in the U.S. Centers for Disease Control and Prevention's division of parasitic diseases, as saying. If left untreated, the infection could cause permanent vision loss or complete blindness.
Neither the FDA nor Advanced Medical Optics said the contact lens solution caused increased cases of Acanthamoeba keratitis, the wire service reported. Rather, the solution didn't protect against the infection, which usually comes from swimming or showering.
Because Acanthamoeba keratitis strikes only one or two people per million, the situation came to the government's notice because only because a Chicago ophthalmologist, Dr. Elmer Tu, noticed more than a dozen cases of the infection. He usually saw only saw one or two cases a year, the A.P. reported.
Medicare Won't Cover Artificial Disc Implants in Older Americans
Older Americans won't receive Medicare coverage for artificial disc implants in the lower spine, according to the a report in the New York Times
The newspaper reports that the decision is preliminary and affects people over the age of 60 who are eligible for the U.S. government's Medicare health insurance. The decision is expected to become final in August, the Times said.
The reason given by the Centers for Medicare and Medicaid Services for denying coverage was that none of the clinical trials conducted on whether the artificial discs were effective included people over age 60.
Therefore, the agency said it had no basis for approving artificial disc surgery for older Americans. At least three companies are affected by the decision: Johnson & Johnson, Synthes and Medtronic. About 43 million Americans -- most of them over 60 -- use the Medicare health program.
Younger patients, most of them disabled, will continue to be eligible for Medicare coverage for artificial disc implantation, the newspaper reported.
Imported Monkfish May Actually be Poisonous Puffer Fish: FDA
Americans should not buy or eat imported fish labeled as monkfish that may actually be puffer fish containing a dangerous and potentially deadly toxin called tetrodotoxin, the U.S. Food and Drug Administration said Thursday.
The agency said that 282 22-pound boxes of the fish were imported from China and distributed by Hong Chang Corp., of Santa Fe Springs, Calif. to wholesalers in Illinois, California and Hawaii beginning in September 2006.
Two people in Chicago became ill after they ate soup made with the fish and one of them had to be hospitalized. Initial symptoms of tetrodotoxin poisoning include tingling of lips, tongue, face and extremities. Subsequent symptoms may include headache, balance problems, excessive salvation, nausea, vomiting, diarrhea and abdominal pain. Anyone with these symptoms should seek immediate medical care, the FDA said.
Severe cases of tetrodotoxin poisoning can cause muscle paralysis and death due to respiratory muscle paralysis.
The boxes containing the fish are white, with one label that reads "FROZEN MONKFISH GUTTED AND HEAD-OFF" and "PRODUCT OF CHINA." A second label includes nutritional facts and the following information: "Ingredients: Monk fish; Imported by Hong Chang Corp, Santa Fe Springs, CA 90670; Product of China (P.R.C.)" A third label has a checkbox indicating the size as either "0.5-1" or "1-2" and show the net weight as 22 pounds.
There are no manufacturing codes on the boxes. The fish are individually wrapped in plastic bags with no labeling.
Kentucky Cardiologist Nominated as Next U.S. Surgeon General
Kentucky cardiologist Dr. James W. Holsinger Jr. has been nominated by U.S. President George W. Bush to be the country's next surgeon general.
Holsinger, a professor of preventive medicine at the University of Kentucky, has held numerous academic and administrative positions. He served as Kentucky's secretary for health and family services, chancellor of the University of Kentucky Medical Center, and has taught at several U.S. medical schools. He also served more than three decades in the United Stares Army Reserve before retiring in 1993 as a major general, the Associated Press reported.
Bush said that, as the 18th surgeon general, Holsinger would focus his efforts on fighting childhood obesity. The Senate should quickly confirm Holsinger, urged Health and Human Services Secretary Michael Leavitt.
The term of the previous surgeon general, Dr. Richard Carmona, was allowed to expire last summer, the AP reported. He was best known for a major report condemning secondhand smoke.
TV Viewing Tied to Higher Blood Sugar in Diabetic Kids
The more time they spend in front of the television, the more difficult it is for diabetic children to control their blood sugar levels, concludes a Norwegian study in the June issue of the journal Diabetes Care.
The three-month study of 538 children with type 1 diabetes found that blood sugar levels increased with every hour of TV viewing. The highest blood sugar levels were in children who watched at least four hours of TV a day, the Associated Press reported.
The study authors said the findings "suggest that encouraging children with type 1 diabetes to watch less television may be important for improved blood glucose control and better health outcomes."
Snacking and overeating can increase blood sugar levels, while physical activity can help lower them. This study focused only on TV viewing. It didn't examine the children's diet or physical activity.
One expert said the study results may suggest that children with type 1 diabetes who already have consistently high blood sugar levels may feel too unwell to do anything but watch TV, the AP reported.
"It's very clear that there's a relationship. Now the question is what underlies that relationship," said Jill Weissburg-Benchell, a psychologist and diabetes educator at Children's Memorial Hospital in Chicago.
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.