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.
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After 8 Years in Prison, Dr. Kevorkian Scheduled for Release Next Thursday
Dr. Jack Kevorkian, in a Michigan prison for more than eight years, is scheduled to leave June 1, after serving part of a 10-to-25 year sentence based on his conviction in helping a seriously ill man kill himself.
Known as "Dr. Death" for his outspoken advocacy of physician-assisted suicide, Kevorkian, 79, is unlikely to resume the unorthodox methods that attracted so much media attention and may have even led to his arrest and conviction, the Associated Press reports.
But with Oregon being the only state that allows physician-assisted suicide, the wire service says that Kevorkian will probably resume his attempts to get the controversial procedure approved in more states.
"It's got to be legalized," the wire service quotes Kevorkian as saying in a phone interview from prison aired by a Detroit TV station last Monday. "I'll work to have it legalized. But I won't break any laws doing it."
According to the A.P., in the nine years since the Oregon law has been on the books, 292 terminally ill people -- or about 32 a year -- have asked their doctors to prescribe the necessary drugs to make their deaths possible.
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Participants Dropping Out of Diabetes Drug's Clinical Trial, Maker Says
The company that makes Avandia, a diabetes drug that came under criticism last week in a published study indicating it could increase heart attack risk, says its large clinical study that might have dispelled those concerns is in jeopardy.
The New York Times reports that the medical director of Avandia's maker GlaxoSmithKline, said that after the report about Avandia's increased coronary risk appeared in the New England Journal of Medicine, some of the 4,450 patients dropped out of a major study designed to test the drug's safety.
Dr. Ronald L. Krall told the newspaper he didn't know how many study subjects had withdrawn, but he was concerned as to whether the trial, scheduled to run through next year, would be completed. About seven million people currently use Avandia.
The U.S. Food and Drug Administration responded to the study findings by issuing a safety alert May 21 but stopped short of a stronger warning label, saying more analysis was needed. "At this point, we have not reached a definitive conclusion on the data," Dr. Robert J. Meyer, director of FDA's Office of Drug Evaluation II, said at the time. "We don't feel there is consistent enough data to make a decision from a regulatory standpoint. We are not ready to make an action."
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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.
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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.
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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.
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