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Misc. News : R.ecalls & A.lerts Last Updated: Nov 12th, 2006 - 20:38:00


Fresh Spinach Cleared for Consumption Again
By
Sep 29, 2006, 20:03

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Health Highlights: Sept. 29, 2006

* FDA Issues Warning About Blood-Loss Drug
* Hotel Visitors Leave Behind Unwelcome Guests: Germs
* California Drug Program Can Be National Model, Group Says
* European Union Approves Anti-Smoking Pill
* Workers at Small Firms Pay Higher Health Premiums
* Judge Halts Medicare Repayment

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

FDA Issues Warning About Blood-Loss Drug

A drug designed to prevent blood loss during certain types of heart surgeries appears to increase users' risks of kidney failure, heart failure and stroke, the U.S. Food and Drug Administration announced Friday. The agency advised doctors to carefully monitor patients given the Bayer Pharmaceuticals drug, Trasylol (aprotinin injection).

The drug, made from the lung tissue of cattle, is used to slow or prevent bleeding, avoiding the need for a blood transfusion. On Sept. 27, Bayer informed the FDA of new study data about Trasylol showing the drug could increase a user's chances of death, serious kidney damage, congestive heart failure and stroke, the agency said in a statement. The study involved 67,000 patients who had undergone coronary artery bypass graft surgery.

The FDA said it was unaware of this new information when its advisors met last week to discuss the drug's safety. The agency said further study was needed since many of the people who were given Trasylol were already at greater-than-average risk of serious complications.

Until the agency is able to review the latest data, it advises doctors to carefully monitor Trasylol patients for damage to the kidneys, heart, or brain, and to promptly report any adverse reactions to Bayer or to the FDA. The agency also says doctors should limit the drug's use to cases where Trasylol's use is "essential to medical management of the patient and outweighs the potential risks."

-----

Hotel Guests Leave Behind Cold Germs

Hotel guests with colds leave behind germs on surfaces like door handles, pens, light switches, and TV remotes after they check out of a room, researchers said Friday at a meeting of the American Society for Microbiology.

The scientists studied 15 people with colds who spent a night in individual rooms at a hotel. After the guests checked out the next morning, researchers tested 10 items in each room that were touched by the sick volunteers. About one third of the items were contaminated with cold viruses, the Associated Press reported.

Cold germs were found on 7 of 14 door handles, 6 of 14 pens, 6 of 15 light switches, TV remotes and faucets, and 5 of 15 phones. Viruses were also detected on alarm clocks, coffee makers, and shower curtains.

However, the germ testing was done before the room was cleaned by hotel staff, the AP reported.

-----

California Drug Program Can Be National Model: Group

A new California bill requiring drugmakers to significantly discount prescription medicines for low-income and uninsured people should send a message to the U.S. Congress that it can do the same for Medicare beneficiaries, says the nonprofit group Consumers Union.

The California bill was to be signed Friday by Gov. Arnold Schwarzenegger. The discount program is expected to offer savings of up to 40 percent on brand name drugs and up to 60 percent on generic drugs to millions of people.

"If California can use its purchasing power to negotiate lower drug prices for the needy and uninsured, why shouldn't Medicare do the same for seniors and the disabled," Earl Lui, senior attorney for Consumers Union, said in a statement.

"California's leaders on both sides of the political aisle agree that drug price negotiation makes sense, not only for patients, but for taxpayers, as well. Congress should do the same and remove the roadblock it specifically put in the Medicare program against price negotiation," Lui said.

In passing the new Medicare Part D drug benefit, Congress prohibited Medicare from negotiating with drug companies for lower drug prices for seniors and the disabled, Consumers Union said.

-----

European Union Approves Anti-Smoking Pill

The European Union has approved the sale of the anti-smoking pill Champix, drugmaker Pfizer said Friday.

Champix (varenicline) will be available with a patient support plan that can be customized by smokers to help them tackle individual smoking behaviors, the Associated Press reported.

It's believed the drug reduces the severity of the urge to smoke and eases many withdrawal symptoms suffered by smokers when they try to quit. The drug may also reduce the satisfaction associated with smoking.

In May, the U.S. Food and Drug Administration approved the drug (sold in the U.S. under the name Chantix) to help smokers quit, the AP reported.

-----

Workers at Small Firms Pay Higher Health Insurance Deductibles

American workers at the largest private-sector companies pay about half as much in health insurance deductibles as workers at the smallest firms, says a report released Thursday by the U.S. Agency for Healthcare Research and Quality.

It said that workers at companies with 1,000 or more employees paid, on average, $859 to meet their deductible for family plan coverage in 2004, while workers at companies with fewer than 10 employees paid an average of $1,779.

The report also said that:

* The average annual deductible for workers in firms with 10 to 99 employees was $1,700, and $1,114 for workers in companies with 100 to 999 employees.
* About 59 percent of private-sector workers were enrolled in company-sponsored health insurance plans that required deductibles to be met before benefits were paid.
* Workers at the smallest firms had an average co-payment of $19.40 per doctor office visit, compared to $17.42 for employees of the largest companies.

-----

Judge Halts Medicare Repayment

A U.S. federal judge on Thursday halted the Bush administration's attempt to recoup about $50 million erroneously paid out to 230,000 Medicare beneficiaries, The New York Times reported.

The mistake involved refunds of premiums paid for prescription drug coverage. The government had ordered the beneficiaries to repay the money by Saturday, Sept. 30.

Judge Henry H. Kennedy Jr. of the Federal District Court in Washington, D.C., said that many of the beneficiaries might qualify for waivers because repayment of the premium refunds might cause them hardship.

He ordered the government to immediately send all 230,000 beneficiaries a notice informing them they have the right under federal law to request such waivers, the Times reported.

Kennedy said the Bush administration can't enforce its demand for repayment of the money unless it first gives beneficiaries the opportunity to seek an exemption. If a beneficiary does request a waiver, the government can't seek repayment until the Secretary of Health and Human Services rules on the request, the judge said.

Last Updated: Sept. 29, 2006

Copyright © 2006 ScoutNews LLC. All rights reserved.


Fresh Spinach Cleared for Consumption Again

U.S. health officials say all tainted products have been recalled, declare spinach 'safe'

By Steven Reinberg
HealthDay Reporter

FRIDAY, Sept. 29 (HealthDay News) -- Consumers got an all-clear from U.S. health officials Friday to buy and eat fresh spinach again.

U.S. Food and Drug Administration officials said late in the day that all the affected brands linked to a nationwide E. coli outbreak had been recalled.

"Spinach on the shelves is as safe as it was before this event," said Dr. David Acheson, chief medical officer for the FDA's Center for Food Safety and Applied Nutrition, in a teleconference, according to Bloomberg News.

Acheson said the tainted spinach all came from Natural Selection Foods, a San Juan Bautista, Calif., grower and processor that supplied many customers.

The company on Sept. 15 recalled all of its spinach products with use-by dates of Aug. 17 to Oct. 1. Four other distributors, all of whom got spinach from Natural Selection, have also recalled their products.

Health officials are still hoping to pinpoint the source of the contamination that has sickened at least 188 people in 26 states and Canada, killing one.

Acheson said they may never know the cause, Bloomberg reported.

As of late Thursday, 97 (52 percent) of the infected people had been hospitalized, 29 (16 percent) had developed a type of kidney failure called hemolytic-uremic syndrome, and a 77-year-old Wisconsin woman had died, according to the U.S. Centers for Disease Control and Prevention.

On Thursday, Natural Selection said it was taking steps to improve its food-safety inspections. The company also said it was ready to pay the medical expenses of consumers sickened by contaminated spinach.

Natural Selection processes fresh spinach for more than two dozen brands, including Earthbound Farm, Dole and Ready Pac. It hasn't been determined whether the spinach was contaminated at the company's plant, or on farms where it was grown in California's Salinas Valley, The New York Times said.

Tainted bags of fresh spinach found in at least five states have all helped pinpoint the E. coli strain. And at least two of the bags tracked back to one specific batch of fresh spinach processed on Aug. 15 at Natural Selection Foods' plant.

FDA officials had said last week that produce other than spinach grown in the Salinas Valley region was not implicated in the E. coli outbreak. They also said processed spinach, either frozen or canned, was not suspect.

And late last week, the FDA had said consumers could resume eating fresh spinach, as long as agriculture industry officials came up with a way to label the products that didn't come from the Salinas Valley.

Friday's all-clear appeared to lift that restriction.

The 26 affected states are: Arizona, California, Colorado, Connecticut, Idaho, Illinois, Indiana, Kentucky, Maine, Maryland, Michigan, Minnesota, Nebraska, Nevada, New Mexico, New York, Ohio, Oregon, Pennsylvania, Tennessee, Utah, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.

Wisconsin has the largest number of reported cases, and the one death. Two other deaths, in Idaho and Maryland, are still under investigation.

And the FDA announced earlier this week that Canada had confirmed its first case of E. coli O157:H7 in a person who ate bagged spinach.

In addition to the Natural Selection recall, the four other companies citing Natural Selection as their source of spinach, are: River Ranch Fresh Foods, which operates in Salinas and El Centro, Calif.; RLB Food Distributors, based in West Caldwell, N.J.; Pacific Coast Fruit Company, based in Portland, Ore., and Triple B Corp. in Seattle.

The primary symptom of E. coli contamination in humans is diarrhea, often with bloody stools. There are an estimated 73,000 cases of infection, including 61 deaths, each year in the United States, according to CDC statistics.

More information

For the latest E. coli updates, visit the CDC.





SOURCES: U.S. Food and Drug Administration; U.S. Centers for Disease Control and Prevention; Bloomberg Neews; Associated Press; The New York Times

Last Updated: Sept. 29, 2006

Copyright © 2006 ScoutNews, LLC. All rights reserved.


MMWR dispath Sept 26, 2006 from cdc.gov

Ongoing Multistate Outbreak of Escherichia coli serotype O157:H7 Infections Associated with Consumption of Fresh Spinach --- United States, September 2006

On September 13, 2006, CDC officials were alerted by epidemiologists in Wisconsin and Oregon that fresh spinach was the suspected source of small clusters of Escherichia coli serotype O157:H7 infections in those states. On the same day, New Mexico epidemiologists contacted Wisconsin and Oregon epidemiologists about a cluster of E. coli O157:H7 infections in New Mexico associated with fresh spinach consumption. Wisconsin public health officials had first reported a cluster of E. coli O157:H7 infections to CDC on September 8. On September 12, CDC PulseNet had confirmed that the E. coli O157:H7 strains from infected patients in Wisconsin had matching pulsed-field gel electrophoresis (PFGE) patterns and identified the same pattern in patient isolates from other states. This report describes the joint investigation and outbreak-control measures undertaken by state public health officials, CDC, and the Food and Drug Administration (FDA). This investigation and additional case finding are ongoing.

As of September 26, a total of 183 persons infected with the outbreak strain of E. coli O157:H7 had been reported to CDC from 26 states (Figure 1). Among the ill persons, 95 (52%) were hospitalized, 29 (16%) had hemolytic uremic syndrome (HUS), and one person died. The deaths of two other patients possibly related to this outbreak are under investigation. Eighty-five percent of patients reported illness onset from August 19 to September 5 (Figure 2). Fresh spinach was identified as the source of the outbreak. One hundred twenty-three of 130 patients (95%) reported consuming uncooked fresh spinach during the 10 days before illness onset. In addition, E. coli O157:H7 with a PFGE pattern matching the outbreak strain has been isolated from three open packages of fresh spinach consumed by patients (one from New Mexico, one from Utah, and one from Pennsylvania).

On September 14, FDA advised consumers by press release and press conference to not eat bagged fresh spinach. On September 15, a California company that bags spinach under several brand names announced a voluntary recall of all fresh spinach-containing products. On September 16, FDA expanded its warning and advised consumers to not eat fresh spinach or fresh spinach-containing products. On September 21, FDA informed consumers that only spinach grown in three California counties (Monterey, San Benito, and Santa Clara) was implicated in the outbreak.

A confirmed case is defined as a culture-confirmed E. coli O157:H7 infection in a person residing in the United States, with illness onset from August 1 to the present (or, if date of onset is unknown, E. coli O157:H7 isolated from August 15 to the present) and a PFGE pattern identified by the XbaI restriction enzyme that matches the pattern of the outbreak strain. August 1 was selected as the earliest illness onset date in the case definition to ensure that the earliest cases in the outbreak were identified and investigated. However, the first six confirmed cases (with illness onsets during August 2--15) were in persons who did not report fresh spinach consumption during the week before illness onset. The first date that illness onset was reported by a person who recently consumed fresh spinach was August 19.

Infections with this outbreak strain of E. coli O157:H7 (one of 3,520 unique E. coli O157:H7 strains reported to CDC PulseNet since 1996) have been reported sporadically to CDC PulseNet since 2003 (an average of 21 cases per year during 2003--2005). This finding suggests the occasional presence of this strain in the environment and food supply; however, it has not been associated with a recognized outbreak in the past.

The time from illness onset to confirmation that a case of E. coli O157:H7 is part of an outbreak is typically 2--3 weeks, including the time required for an infected person to seek medical care and for health-care providers and public health officials to obtain a culture, transfer the bacterial culture to a public health laboratory, perform PFGE testing, and submit the PFGE pattern into the national database at CDC. In this outbreak, the average time from illness onset to PFGE pattern submission to the national database at CDC has been 15 days; additional information is available at http://www.cdc.gov/foodborne/ecolispinach/reportingtimeline.htm.

Parallel laboratory and epidemiologic investigations were crucial in identifying the source of this outbreak. Timely PFGE testing by state public health laboratories, PFGE pattern submission by states to CDC PulseNet, and analysis of PFGE patterns in the CDC PulseNet national database resulted in rapid detection of the outbreak. Concurrent collection of case exposure information by epidemiologists in affected states and sharing of exposure information among states and CDC led to rapid identification of the suspected food source and public health action. Continued rapid diagnosis, culture, PFGE analysis, and reporting to CDC of E. coli O157:H7 infections are needed to aid this investigation and to detect and investigate E. coli O157:H7 outbreaks in the future.

New information regarding the current E. coli O157:H7 outbreak will be available regularly. The most current information is available online at http://www.cdc.gov/foodborne/ecolispinach; this website contains information updated daily on the number of cases and affected states in addition to general information regarding E. coli O157:H7, resources for clinicians, and activities by CDC and other agencies. The FDA website, at http://www.fda.gov/oc/opacom/hottopics/spinach. html, contains advice for consumers on the current outbreak and food-safety guidelines. CDC's public inquiry line (telephone, 1-800-CDC-INFO) also can provide information on the current outbreak to both the public and health-care workers. Information about the current E. coli O157:H7 outbreak is also available by RSS (Really Simple Syndication); a subscription to the E. coli O157:H7 outbreak RSS information can be obtained at http://www.bt.cdc.gov/rss.

Reported by: State and local health departments. E. coli O157:H7 investigation team, CDC.




© 2004-2005 by foodconsumer.org unless otherwise specified

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