Showing posts with label Food and Drug Administration. Show all posts
Showing posts with label Food and Drug Administration. Show all posts

Sunday, October 21, 2012

Another Supermarket Chain Will Permanently Stop Selling Sprouts Due To 'Potential Food Safety Risk'

Elizabeth Weise, USA TODAY
Kroger , the nation's largest supermarket chain, has announced it will stop selling sprouts on Monday because of their "potential food safety risk." It joins retail behemoth Walmart, which quietly stopped selling the crunchy greens in 2010.
"After a thorough, science-based review, we have decided to voluntarily discontinue selling fresh sprouts," Payton Pruett, Kroger's vice president of food safety, said in a statement.
"This is big," said Marion Nestle, a professor of food safety at New York University. "This is a major retailer saying 'We aren't going to take it anymore. We can't risk harming our customers, and our suppliers are unwilling or unable to produce safe sprouts.' "
The industry's trade group expressed concern but said it was working to keep its products safe.
"We hope that the Kroger decision doesn't have a domino effect," said Bob Sanderson, president of the International Sprout Growers Association. The industry, which depends on sampling and testing to insure sprouts are not contaminated with pathogens, is working with the Food and Drug Administration and other groups to create better safety protocols.
"We're trying, but it's very challenging," Sanderson said. "These organisms can be anywhere." The industry is also working towards a "sprout-specific" food safety audit for producers.
Walmart stopped selling sprouts two years ago, in October 2010, said spokesman Kory Lundberg.
"It really comes down to our commitment to our customers' safety and knowing the microbial risk associated with sprouts," he said. However, he added the company continues to work with the sprout growing industry to create "enhanced food safety controls and microbial intervention strategies that would result in safer sprouts."
Between 1990 and 2010, more than 2,500 Americans were sickened by contaminated sprouts in at least 46 outbreaks, according to data from the Centers for Disease Control and Prevention. Salmonella was identified in 37 of the 46 outbreaks, E. coli with eight and listeria with one.
"It's great news," said Caroline Smith DeWaal, food safety director with the Center for Science in the Public Interest in Washington. Simply because of the way sprouts are grown they're "unavoidably unsafe," she said.
As the FDA says, "seeds and beans need warm, humid conditions to sprout and grow. These are the same conditions that are ideal for bacteria to grow, including dangerous bacteria like salmonella if they are present." The seeds used for sprouts can carry pathogens inside, where they're very hard to kill. Methods to destroy the contamination, such as irradiating the seeds or soaking them in bleach, haven't proved successful.
The Cincinnati-based supermarket chain operates 2,425 supermarkets in 31 states under names including Kroger, City Market, Dillons, Jay C, Food 4 Less, Fred Meyer, Fry's, King Soopers, QFC, Ralph's and Smith's.
Recent large sprout based outbreaks include:
-April 2012. Clover sprouts linked to infection with an E. coli variant in 29 people infected in 11 states.
-June 2011. Alfalfa sprouts contaminated with salmonella enteritidis sickened 21 people in five states, three of whom required hospitalization.
-May-June 2011. Fenugreek sprouts sickened more than 4,300 people and killed 50 in Europe, the United States and Canada.
-April-July 2011. Alfalfa sprouts and spicy sprout mix were linked to salmonella enteritidis that affected 25 people in five states.
-Nov. 2010-Feb. 2011. "Tiny greens" alfalfa sprouts and "spicy sprouts" sickened 140 people with salmonella in 26 states; 24(PERCENT) are hospitalized.
Mung bean sprouts have long been a component of Chinese cuisine, quickly stir fried as a vegetable. Alfalfa sprouts became popular in the 1970s in the United States as part of an overall trend towards fresh food and healthy eating. Broccoli sprouts became an overnight sensation in the 1990s when scientists at Johns Hopkins University found a cancer-fighting chemical in broccoli that was present in even higher concentrations in sprouts.
FDA and the Centers for Disease Control and Prevention advise that children, the elderly, pregnant women and people with weakened immune systems should avoid eating raw sprouts of all kinds, including alfalfa, clover, radish and mung bean sprouts. Sprouts can be "cooked thoroughly to reduce the risk of illness," the FDA says.

Tuesday, September 4, 2012

Statin benefits outweigh diabetes risk, study finds


Six months after the US Food and Drug Administration required cholesterol-lowering statin drugs to carry warnings about diabetes risks, Brigham and Women’s Hospital researchers conclude in a new analysis of a landmark study that the increased likelihood of diabetes is outweighed by the drugs’ protective effects against heart attacks, strokes, and heart disease deaths.

The new study, published Thursday in the journal Lancet, delved into findings from a 2008 clinical trial involving nearly 18,000 adults without heart disease or high cholesterol but with high levels of artery-damaging inflammation. That trial found a small increased diabetes risk among people who took rosuvastatin (Crestor). The new analysis shows that the bulk of the extra diabetes cases occurred in certain statin users: those already on the verge of getting the disease because of being obese or having an elevated blood sugar levels or resistance to the hormone insulin.
“We’re not seeing any excess risk in those who have normal blood sugar levels and no other risk factors for diabetes,” said study leader Dr. Paul Ridker, a Brigham cardiologist.
The original study, called Jupiter, and the followup analysis were funded by Crestor manufacturer AstraZeneca, and Ridker holds a patent on the test used in the trial to measure inflammation.
While statins have been shown to have life-saving benefits in patients already diagnosed with diabetes or in those who have had previous heart attacks, their use for preventing future heart attacks and strokes in healthier patients has come into question as diabetes risks have become more widely known. But the latest finding should provide reassurance to patients taking statins for the prevention of heart disease, said Dr. Allison Goldfine, head of clinical research at the Joslin Diabetes Center.
In patients at increased risk for diabetes, statins, when compared with a placebo, reduced the overall risk of dying or of having a heart attack, stroke, or other serious heart complication by 39 percent, the study found, while raising the risk of getting diabetes by 28 percent.
In absolute terms, 134 vascular complications or deaths were avoided for every 54 new cases of diabetes diagnosed during the trial in these high-risk patients, who were followed for an average of two years. The researchers found that the increased diabetes risk applied only to those who were already on the threshold of developing the disease — speeding up their time to diagnosis by about five weeks on average.
“Statins may bring on diabetes a little earlier, but the condition is manageable,” Goldfine added. “But the leading cause of death in diabetics is heart disease, and that’s what statins help prevent.”
Despite the finding from the Jupiter trial that statins provided net benefits for those with an elevation in an inflammatory marker called C-reactive protein but not high cholesterol, doctors have been largely reluctant to prescribe the drugs solely on the basis of elevated CRP levels because of concerns about diabetes and other side effects, such as muscle aches and rare but serious kidney or liver complications.
While the latest finding may shift practices somewhat toward prescribing statins more frequently, some doctors said the benefits are still very small in a population at low risk of having a heart attack.
“The study found only a marginal benefit for reducing major heart events, and it’s a narrow tradeoff with the increased diabetes risk,” said Dr. Eric Topol, a cardiologist at the Scripps Clinic in La Jolla, Calif. “It’s not an acceptable reason to give rosuvastatin to those whose only risk is a high CRP.”
One reasonable approach doctors can take, said Goldfine, would be to analyze a patient’s heart disease risk factors, including age and family history, and to get a CRP measurement in those with a moderately high risk of having a heart attack during the next 10 years. “The CRP test could be a very valuable part of the decision in determining whether these patients should be on a statin.”