Quality problems have prompted Indianapolis-based Guidant Corp. to suspend shipments of a new heart stent in Europe and to halt enrollment of patients in a clinical trial in Japan to test the stent.
About one percent of the new drug-coated Xience stents did not meet quality standards, but no patients were harmed by the stents, the company said in a statement released Wednesday. It did not divulge how many of the poor quality stents were implanted in patients.
The sale of Xience stents in 25 European countries will be delayed until later this year. The stent has not yet been approved for sale in the United States, but Guidant did notify the U.S. Food and Drug Administration about the suspension of shipments, Bloomberg news reported.
The faulty stents were made at Guidant's plant in Temecula, Calif.
"We have determined the root cause of the issue, have instituted corrective measures and have resumed manufacturing," the company said in its statement.
Last year, defects forced Guidant to recall more than 100,000 implantable heart defibrillators.
Candy Eggs Recalled
The Anthony-Thomas Candy Co. of Ohio is recalling packages of filled Easter candy eggs that may contain undeclared egg whites and the food colorings yellow # 5 and yellow #6.
People who are allergic or have a severe sensitivity to eggs could suffer a serious or life-threatening reaction if they eat the candies. The company said there have been no reports of such incidents.
The recall covers 6-ounce and 12-ounce packages of candy eggs filled with butter cream, peanut butter, fruit and nut, chocolate fudge, coconut cream, chocolate fudge pecan, and maple walnut fudge. The recalled packages carry production code numbers 6027 through 6083, the Associated Press reported.
The candy eggs were sold in a cardboard package with a clear cellophane top panel. The candies were sold in retail stores between Jan. 27 and March 27 in the following states: Alabama, Colorado, Connecticut, Illinois, Iowa, Massachusetts, Michigan, Mississippi, New York, Ohio, Tennessee, Texas, West Virginia and Wisconsin.
Consumers can return the candies to the place of purchase for a full refund. For more information, contact the Anthony-Thomas Candy Co. at (877) 226-3921.
FDA Approves 2nd Drug for Flu Prevention
The antiviral drug Relenza has been approved for prevention of influenza A and B in adults and children five years or older, the U.S. Food and Drug Administration said Wednesday. The drug was already approved to treat influenza.
Relenza is the second drug to be given FDA approval for prevention of influenza. The other is Tamiflu, which is also approved to treat influenza.
"This approval (of Relenza) is a welcome addition to the available defenses against the flu. This new use offers the medical community another option to prevent and control influenza A and B," Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said in a prepared statement.
Relenza is made and distributed by GlaxoSmithKline Inc. based in Research Triangle Park, N.C.
Two studies found that flu struck 4.1 percent of households that took Relenza, compared to 19 percent of households that took a placebo.
Tobacco Companies Contest Payment to States: Report
Large U.S. tobacco companies are negotiating with states in a dispute involving $1.2 billion of a $6.5 billion payment the companies must give the states by mid-April under the $246 billion Master Settlement Agreement of 1998.
The companies contend that they're entitled to pay less because the states did not "diligently enforce" statutes that require smaller tobacco companies that aren't part of the agreement to create escrow accounts to cover losses in any future legal action that might include them, The New York Times reported.
Because of this, the large tobacco companies say they should not have to pay $1.2 billion of the next installment of $6.5 billion that has to be paid to the states by April 17.
"We believe the states have diligently enforced their statutes. We are negotiating with the companies to make sure they pay the full amount," Tom Miller, the Iowa attorney general and co-chairman of the National Association of Attorneys General tobacco committtee, told the Times.
Doctors Remove 2 Dead Fetuses From Baby Girl
Doctors in Pakistan operated on a 2-month-old girl to remove two dead fetuses that grew inside her while she was in her mother's womb.
The infant was in critical condition following the two-hour operation Tuesday.
"It is extremely rare to have two fetuses being discovered inside another. Basically, it's a case of triplets, but two of the siblings grew in the other," Zaheer Abbasi, head of pediatric surgery at The Children's Hospital at Pakistan Institute of Medical Science, told the Associated Press.
Abbasi led the operation to remove the two partially grown fetuses that weighed a total of about two pounds. The two fetuses had died at about four months' gestation.
He said it was the first such case -- called fetus-in-fetu -- he was aware of in Pakistan. He did not know what caused it, the AP reported.
Fetus-in-fetu occurs in about one per 500,000 births, said a report in the June 2000 issue of the journal Pediatrics.
No Safety Concerns About Benzene in Soft Drinks: FDA
Tests for cancer-causing benzenes in soft drinks have raised no safety concerns, the U.S. Food and Drug Administration said Tuesday. But the agency did not release details about the test results.
The FDA began testing soft drinks after a private study released in late 2005 said it found small amounts of benzene in some soft drinks, the Associated Press reported.
While a few of the drinks sampled had slightly elevated levels of benzene, the vast majority did not have any benzene or had levels that were below the U.S. federal limit for drinking water, the FDA said.
The agency will continue testing soft drinks and plans to release findings "when we have a more complete understanding of the current marketplace," Robert E. Brackett, director of the FDA's Center for Food Safety and Applied Nutrition, wrote in a letter released Tuesday.
The FDA's letter was criticized by the Environmental Working Group, which wants the agency to warn the public about soft drinks that contain two ingredients -- ascorbic acid and benzoate preservatives -- that can form benzene.
"Notably, they don't give us the data," Richard Wiles, the group's senior vice president, told the AP. "We simply asked them to disclose the results of their testing. If there's nothing to hide, why won't they show us numbers? It might be a small percentage, but there is some percentage of drinks that have very elevated levels of benzene."
Food Fact: Lose 15 lbs. this year.
One important change in your lunchtime routine can make all the difference. In one study, women who ate at least five restaurant/takeout meals a week took in almost 300 more calories a day than women who ate out less often, with a larger proportion of calories from fat. Over a year's time, those calories can add up to an extra 15 - 20 pounds. Try bringing lunch from home -- not only will it help you lose weight, but it'll fatten your wallet by cutting down on expenses!
Fitness Tip of the day: Gotta move...
Fitting extra activity into your day is effortless when you make a few key choices. Take three examples: 1) Instead of sitting at a movie for two hours, go bowling. 2) Leave your car home and walk to public transportation. 3) Hide the remote control and get up every time you want to change channels.
FAQ of the day: Is it better for me to eat cruciferous vegetables raw?
Cooking affects the cancer-protective compounds in cruciferous vegetables to a degree. The sulforophane in broccoli is fairly stable in the presence of heat, although cooking it for a long time will diminish it. Stick with quick-cook methods, such as steaming or boiling in a small quantity of water, if you can. The protective compound in watercress, PEITC, is present in cooked watercress, though at greatly diminished levels compared with raw watercress. But studies in people who've eaten cooked watercress show that some PEITC remains active.