FDA links new blood clots birth control drugs

WASHINGTON (AP) - concerns of security with the popular birth control pill as yaz increased federal Thursday that scientists of Health reported that the drug from Bayer and other newer birth control treatment appear to increase the risk of dangerous blood clots more older drugs.

A new study published by the Food and Drug Administration reviewed the medical history over 800,000 women U.S. takes different forms of control of births between 2001 and 2007. On average, women taking Yaz had 75% more likely to end up with a blood clot than women older birth control medications.

YAZ contains estrogen with a synthetic hormone of next generation called drospirenone, who is known to increase the level of potassium in the blood. FDA compared the medical records of women taking the drug with those who take the old drug levonorgestrel.

YAZ, Yasmin and related pills containing drospirenone of were free of second-best-selling Bayer to $ 1.6 billion in global sales last year.

In 2009, the FDA has taken an unusual step order Bayer to run corrective on Yaz TV advertisements, stating that the ability of drugs exaggerated the drugmaker marketing campaign to prevent acne and premenstrual syndrome.

Bayer Healthcare, a division of the German conglomerate, it says "currently assessing this publication and cannot comment on at this time."

The Agency also reported complications higher in women using the Ortho Evra of Johnson & Johnson and ring patch vaginal Nuvaring of Merck & Co. Inc. These drugs combine estrogen, which is present in all birth control pills, with two other synthetic hormones in the last decade.

The FDA said it has not reached a final conclusion on the safety of the drugs but will hold a meeting with scientific advisors on 8 December.

The consumer safety advocates have criticized the Agency of the latest and most expensive birth control drug approval when cheaper, generic medicines with established security records are widely available.

"At some point we must ask why the FDA continues to approve drugs that are less safe and have no advantage over drugs already on the market," said Dr. Diana Zuckerman, President of the National Centre for women and families, a group of consumers for women's health issues. "With all these different birth control options, why take the more expensive that can kill you?"

Recent studies have reached different conclusions about the risks of contraceptive pills more recent.

A study published earlier this week on more than 1 million Danish women found that women taking Yaz and other newer drugs have twice the risk of blood clots as women taking the hormone levonorgestrel older. The findings published Tuesday in the British Medical Journal.

However, two studies published in 2007, conducted as part of the regulators FDA postmarketing requirements or European, have not found any difference in clotting between comparable groups.

Pills of birth control containing drospirenone include Yaz, Yasmin, Bayer's Beyaz, Safyral; Sandoz Syeda and Loryna; as well as Ocella Barr, Watson Pharmaceuticals Zarah and Loryna of Teva Pharmaceuticals laboratories.

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Study links neighborhood to obesity risk

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Research has linked obesity to neighborhood features such as the number of supermarkets and fast-food restaurants.Rates of diabetes and severe obesity are about one-fifth lower in the women who movedFactors could contribute to better health in low-poverty areas, including healthy foodsJust 16% of the women who moved to low-poverty areas had diabetes

(Health.com) -- When federal housing officials created a program in the mid-1990s to help single-mother households in poor neighborhoods relocate to low-poverty areas, they weren't merely interested in providing access to better homes, jobs, and schools. They also wanted to study how the families who moved out changed over time compared to those who stayed put.

After more than a decade, moving from high- to low-poverty areas seems to have had little impact on economic measures such as employment and income. But researchers have discovered an interesting side effect of the program: In a new follow-up study published this week in the New England Journal of Medicine, they report that rates of diabetes and severe obesity are about one-fifth lower in the women who moved than in those who did not.

The apparent improvements in health associated with low-poverty areas are comparable to the typical outcomes seen with programs that encourage healthy eating or exercise, or that provide medications to people with diabetes, says Jens Ludwig, Ph.D., the lead author of the study and a professor of social service administration, law, and public policy at the University of Chicago.

"For this program, health improvements were not the primary goal," Ludwig says. "But the fact that we're seeing effects in the ballpark of what you'd get with very direct, targeted interventions designed for weight loss, for example, [is] pretty striking."

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Several factors could contribute to better health in low-poverty areas, including greater access to healthy foods, a safer environment more conducive to outdoor exercise, and lower levels of psychological stress, Ludwig says. The move "changed a bunch of things at one time for these families, so it's hard to tease out exactly what made a big difference for them," he says. "But all of these things seem like plausible explanations."

Troy Blanchard, Ph.D., an associate professor of sociology at Louisiana State University, in Baton Rouge, who studies health and obesity in poor rural areas, says the findings draw attention to an often-ignored aspect of the obesity and diabetes epidemics.

"Oftentimes, research really focuses on people's decisions, and what they do wrong, and how they are at fault, essentially, for being obese or having a disease or a poor diet," says Blanchard, who was not involved in the study. "This provides evidence that it's not just the individual's decisions, but...also the environment -- the neighborhood -- that really does matter."

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The idea that neighborhoods can have an impact on health is not new. Studies on this topic date back to the 1700s, Ludwig points out, and more recently a growing body of research has linked obesity and other health problems to neighborhood features such as the number of supermarkets and fast-food restaurants. But this is the first time researchers have been able to compare moving out of a neighborhood with staying behind, in the same way that new drugs are compared with placebos in clinical trials.

The relocation program, known as Moving to Opportunity, began in 1994 when the U.S. Department of Housing and Urban Development partnered with local housing authorities to recruit low-income families living in public housing in Baltimore, Boston, Chicago, Los Angeles, and New York.

The families who volunteered for the program were sorted into three groups via random lottery: Some received vouchers that enabled them to move into areas with a low poverty rate (below 10%) at the same rent they were paying in public housing, some received vouchers that could be used anywhere, and some -- the control group -- received no new vouchers or assistance.

Years later, between 2008 and 2010, Ludwig and his colleagues followed up with 3,186 women who participated in the program. The researchers calculated each woman's body mass index, or BMI (a simple ratio of height to weight), and collected blood samples, which they tested for a type of protein that indicates average long-term levels of blood sugar.

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Of the women who stayed in their original neighborhoods, 20% had blood-sugar levels consistent with diabetes and 18% had a BMI of at least 40 (the unofficial cutoff point for morbid obesity). These rates were not measurably different among the women who received unrestricted vouchers. By contrast, just 16% of the women who moved to low-poverty areas had diabetes and just 14% were morbidly obese.

"We went in wondering to what degree a real randomized experiment would confirm -- or not confirm -- what a lot of people already believed," Ludwig says. "The most surprising thing was not that it did confirm the belief, but the significant size of the effect."

The study doesn't claim that moving from a high- to low-poverty area guarantees weight loss or protection from diabetes. The health measures used in the study weren't recorded before 2008, so the researchers weren't able to track how moving affected the health of individuals over time. In addition, all of the Moving to Opportunity participants were volunteers, raising the possibility that they differ in key ways from the average public housing resident. (The volunteers were more likely than their neighbors to be concerned about crime, for instance.)

Despite the study's limitations, Ludwig and his colleagues conclude that public health programs that target obesity and diabetes in high-poverty neighborhoods "could generate substantial social benefits." This message is important for policymakers and community organizers, but also for individuals living in these neighborhoods, Blanchard says.

"It shows that being active in your community and working to make safer, healthier environments can really affect the health of the people who live there," he says. "Not everyone can move out of their neighborhood, but maybe there's a chance to improve what's there."

Copyright Health Magazine 2010

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DNA links listeria outbreak to Colorado cantaloupe grower

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By Keith Coffman

DENVER | Fri Sep 16, 2011 10:28pm EDT

DENVER (Reuters) - Lab tests by Colorado health officials confirmed a listeria outbreak that has killed at least two people is linked to cantaloupe grown at a farm in the southeast part of the state, officials said on Friday.

Jensen Farms Inc of Holly, Colorado, which has voluntarily recalled all its melons shipped to 17 states, was named as the source. The farm is about 200 miles southeast of Denver.

The determination by Colorado health officials came one day after the U.S. Food and Drug Administration warned consumers not to eat any melons raised at Jensen Farms.

Listeria monocytogenes is a virulent bacterium that can thrive at low temperatures and causes about 1,600 people in the United States to fall ill with flu-like symptoms each year, killing more than 250, according to the Centers for Disease Control and Prevention.

"Cantaloupe samples from the refrigerator of a listeria patient's home, as well as samples obtained from various retail outlets last week, have the same DNA fingerprints as the listeria that has infected 12 Colorado residents," the Colorado Department of Public Health and Environment said in a statement on Friday.

"All of the listeria-positive cantaloupe samples at this time appear to have been grown at Jensen Farms."

The listeria outbreak has infected 22 people in seven states and caused two deaths, the CDC said on its website.

Listeria outbreaks are usually associated with deli meats, unpasteurized cheeses and smoked refrigerated seafood products. This is just the third outbreak of the food-borne illness traced to fresh produce, the FDA said.

Health officials warn pregnant women, people over the age of 60 and those with compromised immune systems not to consume items known to be linked to the bacteria.

Those infected with the gastrointestinal illness experience flu-like symptoms, and in extreme cases can suffer convulsions and miscarriages or stillbirths in pregnant women. Antibiotics are effective in treating the infection in most cases.

(Editing by Alex Dobuzinskis and Peter Bohan)

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