US adds clot risks to some birth control labels

"US health authorities on Tuesday ordered revised labels on some types of birth control including German pharmaceutical giant Bayer's Yaz pills to advise of a possibly higher risk of blood clots. (AFP Photo/John MacDougall)" title

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US adds more on clot risk to some birth control pills

Reuters – 6 hrs ago WASHINGTON (Reuters) - U.S. health regulators are adding information to the labels on a popular class of birth control pills that includes Bayer AG's Yaz and Yasmin, to show they may raise the risk of blood clots.

All common birth control pills increase a woman's chances of getting potentially fatal blood clots.

But the U.S. Food and Drug Administration said on Tuesday that some studies showed the danger may be even higher for more recent pills that contain the compound drospirenone, a synthetic hormone.

"The revised drug labels will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products ... whereas other epidemiological studies found no additional risk," the FDA said in a statement.

The FDA's own study found that 10 in 10,000 women taking pills with drospirenone would get a blood clot per year, compared with about six in 10,000 women taking older contraceptives.

A clot in blood vessels can prove fatal if it breaks loose and travels to the lungs, heart or brain.

To put the risk into perspective, the FDA added that the risk of blood clots from pregnancy is even higher than any risk from birth control pills.

The announcement comes after an advisory committee of outside experts to the FDA voted in December for a label revision for pills with drospirenone, calling for clearer information about their risks and benefits.

The experts stopped short of agreeing that these pills' risks outweighed their benefits, since some studies found the pills did not increase blood clot risks.

In January, the Project on Government Oversight, a U.S. watchdog group, urged the FDA to hold a new vote about the birth control pills after a study showed four of the FDA's advisers had ties in the past to makers of pills containing drospirenone.

The FDA said past ties to industry are usually not considered conflicts under the law.

During the December panel meeting, some women's advocacy groups called for the pills to be taken off the market, as the studies that viewed pills favorably were industry-funded.

The consumer groups and patients shared tearful stories about sudden deaths or life-changing disabilities they or their loved ones suffered from blood clots, which they believed were caused by Yaz or Yasmin.

Yaz, a reformulated version of Yasmin, remains one of the U.S. top-selling contraceptives. Bayer had $374 million in Yaz sales in 2010, according to data from IMS Health. Sales of Yaz have slipped in recent years, after Teva Pharmaceutical Industries and Watson Pharmaceuticals launched generic versions.

Cynthia Pearson, executive director of the National Women's Health Network, who testified at the December meeting, said that a simple label change would not necessarily protect women from blood clots.

"I fear that if the FDA holds another public hearing three years from now, there will be a new group of women telling sad stories about the harm done to their health by clots," she said on Tuesday.

Most common contraceptive pills combine the hormones estrogen and progestin to help block ovulation and sperm. But they also increase the chance of a woman getting blood clots compared to not taking pills, particularly as she ages.

(Reporting by Anna Yukhananov in Washington and Anand Basu in Bangalore; Editing by Tim Dobbyn)

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FDA details blood clot risk on birth control pills

Federal health regulators said Tuesday they are adding labeling to Yaz and other newer birth control pills emphasizing that the drugs may be more likely to cause blood clots than older contraceptive pills.

The labeling will apply to Bayer's Yaz, its predecessor Yasmin and similar drugs containing the manmade hormone called drospirenone, which mimics the naturally occurring female hormone progesterone. The drugs are among the best-selling contraceptives in the U.S., due to marketing emphasizing their ability to clear up acne and other hormone-related issues.

The FDA said the new labeling will detail recent studies suggesting drospirenone-containing pills carry a slightly higher risk of blood clots than other birth control pills. The risk of blood clots with either group of drugs is still very rare.

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Online Tool Could Diagnose Autism Quickly, Developers Say

HealthDay – 2 mins 52 secs ago TUESDAY, April 10 (HealthDay News) -- A new online procedure could cut from hours to minutes the amount of time it takes to accurately diagnose autism in young children, resulting in earlier treatment, a new report by Harvard Medical School researchers says.

The process relies on seven questions plus a short home video of an individual child.

The research team said its method could reduce by nearly 95 percent the time it takes to diagnose autism and could be easily included in routine child screening practices, greatly increasing the number of at-risk children who get checked for the disorder.

"We believe this approach will make it possible for more children to be accurately diagnosed during the early critical period when behavioral therapies are most effective," Dennis Wall, an associate professor of pathology and director of computational biology initiative at the Center for Biomedical Informatics, said in a medical school news release.

The research is published in the April 10 online edition of the journal Nature Translational Psychiatry.

Currently, children being evaluated for autism typically take a 93-part questionnaire and/or an examination that assesses several types of behaviors. These evaluations must be performed by a trained clinician and can take up to three hours to complete.

In many cases, there is a delay of more than a year between initial signs of autism and a diagnosis. This is due to waiting times to see a professional who can administer the tests and deliver the formal diagnosis, Wall explained.

He and his colleagues examined data from more than 800 people who were diagnosed with autism and found that only seven questions were needed to diagnose autism with nearly 100 percent accuracy.

The researchers also found that a shorter assessment of behavioral traits could be used to evaluate children, and this could be achieved by viewing short home video clips of children.

"With this mobilized approach, the parent or caregiver will be able to take the crucial first steps to diagnosis and treatment from the comfort of their own home, and in just a few minutes," Wall said.

One expert said that such a test would be useful, but more research into its effectiveness is needed.

"Although the accuracy and specificity of the abbreviated approach are impressive, it is likely that this abbreviated approach to testing may not be quite as accurate and discriminating when evaluating a more diverse sample than was included in the study just reported," said Dr. Andrew Adesman, chief of developmental and behavioral pediatrics at Steven & Alexandra Cohen Children's Medical Center of New York, in New Hyde Park, N.Y.

"At this time, concerned parents are advised to discuss concerns about their child's development with their pediatrician. Children under 3 years of age are entitled to a free developmental evaluation through their local early intervention program. Likewise, preschool children (ages 3 to 5) can be evaluated for free through their local school district," he added.

"Pediatricians and pediatric sub-specialists are generally able to make a clinical diagnosis of autism using current diagnostic criteria," Adesman said, and "families wishing a second opinion about a child with possible autism may wish to consult with a developmental pediatrician, child neurologist or child psychiatrist."

More information

Here's where you can find the seven-question survey.

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EKG Heart Test May Predict Risk in Older Adults

HealthDay – 4 hrs ago TUESDAY, April 10 (HealthDay News) -- Minor changes in the results of a commonly used heart test -- an electrocardiogram, or EKG -- translate into a 35 percent increased risk of heart events, such as heart attacks, hospitalizations for chest pain or the need for heart surgery, in people over 70, according to new research.

For people with major abnormalities in their EKG, the risk of having a heart event is even higher, compared to people with normal tests.

"We analyzed data from the Health, Aging and Body Composition Study. More than 3,000 patients had an electrocardiogram done at baseline, but we only included the people who didn't have a previous history of coronary heart disease or cardiovascular disease, so no heart attacks or strokes," said lead study author Dr. Reto Auer, a research fellow in the department of epidemiology and biostatistics at the University of California, San Francisco.

"We found that people who had minor or major changes in their electrocardiogram had a greater risk of heart events," Auer said. "And, when we adjusted the data for commonly known risk factors -- smoking, cholesterol, body mass and high blood pressure -- we still found an association between minor or major EKG changes and heart events."

Results of the study are published in the April 11 issue of the Journal of the American Medical Association.

An EKG is a painless and noninvasive test that records each heartbeat onto a piece of paper. To conduct the test, clinicians attach numerous wires to your chest and legs to capture each heartbeat.

The test is commonly included as part of a routine physical, though the widespread use of this test in people without any cardiac symptoms has recently come into question. While it may be noninvasive, it's not without risk. People who have abnormal test results are often referred to specialists and for more tests, which may be invasive. In addition, if the results of the EKG suggest an increased risk, someone might be placed on a new medication to reduce their risk.

"The American College of Cardiology currently recommends against routine screening in asymptomatic individuals unless there are risk factors," said Dr. David Friedman, chief of heart failure services at North Shore-LIJ Health System's Plainview Hospital, in Plainview, N.Y.

The U.S. Preventive Services Task Force and the American Heart Association also do not recommend routine EKG screening in people without symptoms or risk factors, according to an accompanying editorial in the same issue of the journal.

"Just because its use is widespread and it's cheap doesn't mean it should necessarily be given to everyone. While it might seem to make sense, where does it stop? Why just get an EKG? Why not an echocardiogram or a cardiac stress test, too? All of these tests have to be used rationally and cost-effectively. This is still a gray area," Friedman said.

The current study is a first step in assessing how electrocardiograms might effectively be used in an older population, the researchers suggested.

From the larger study, the investigators analyzed data on 2,192 people who had no history of heart disease or stroke, but had undergone an EKG at the start of the study.

All of the study volunteers were between the ages of 70 and 79. Fifty-five percent of study participants were women and 59 percent were white. The study included an average eight years of follow-up information.

The researchers found that people who had minor abnormalities in their EKG at the start of the study were 35 percent more likely to experience a heart event than those without any abnormalities. Those with major EKG abnormalities had a 51 percent greater risk of having a heart event.

Auer said even with this study's findings, it's too soon to recommend routine screening with EKG. "Prediction is not prevention," he said.

An additional issue that both doctors mentioned is that the EKG test is only as good as the person who's reading the test. Major abnormalities are generally easy to see, but minor ones aren't always as easy to interpret, Auer and Friedman said.

"I see minor abnormalities all the time, and variable changes in the same patient from year to year. There are some things we expect that are normal variants," Friedman said.

Until the experts sort out the best way to use EKG to help them predict someone's risk of a heart attack, Auer said that it's important to talk to your doctor about your heart disease risk factors, such as high blood pressure, high cholesterol and smoking. Making changes in these risk factors is already known to reduce the risk of heart disease. It isn't yet known if changing the results of your EKG will help lower your heart disease risk, he noted.

More information

Learn more about the electrocardiogram test from the U.S. National Heart, Lung, and Blood Institute.

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High Blood Pressure May Be Especially Lethal for Blacks

HealthDay – 4 mins 48 secs ago TUESDAY, April 10 (HealthDay News) -- Black people with high blood pressure are twice as likely to suffer sudden cardiac death than whites or other racial groups who suffer hypertension, according to a new study.

Researchers found this was true regardless of blacks' other risk factors, such as age, gender, family history, weight, diabetes or pre-existing heart disease.

Researchers examined 533 black and 8,660 non-black patients with high blood pressure and followed them for five years. Sudden cardiac death occurred in 178 patients, including 17 blacks and 161 non-blacks. After adjusting for risk factors such as age, sex, body mass index (a measure of body fat based on height and weight), diabetes and history of heart disease, the study revealed black patients had a two-fold greater risk of sudden cardiac death.

In sudden cardiac death, the heart unexpectedly stops beating, causing blood flow to the brain and organs to stop. If blood flow isn't restored through CPR or defibrillation, death occurs within minutes.

The study appears in the April issue of HeartRhythm.

"The truly unique outcome of our study is the indication that black patients may be at a higher risk of

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Common Blood Pressure Drug Safe for Heart Failure: Study

HealthDay – 4 mins 46 secs ago TUESDAY, April 10 (HealthDay News) -- Although research has suggested that the blood pressure drug losartan (Cozaar) may be tied to an increased risk of death in heart-failure patients compared to a similar medication, a new study finds that's not the case.

"Use of this and other similar drugs has been shown to reduce morbidity and mortality in patients with heart failure," said Dr. Gregg Fonarow, co-director of the Preventative Cardiology Program at the University of California, Los Angeles, and director of the Ahmanson-UCLA Cardiomyopathy Center, commenting on the study results.

An earlier observational study in patients with heart failure suggested that losartan was associated with higher risk of death compared to the drug candesartan (Atacand), he said.

"There were, however, a number of limitations to this prior study that could have biased these results, including differences in dosing and treating physicians," said Fonarow, who was not involved in the studies.

The new research, conducted in Denmark, finds no meaningful difference in survival among heart failure patients treated with losartan or candesartan, he said.

"This study also finds for both agents that the use of higher doses, as recommended in guidelines, is associated with better outcomes than the use of lower doses," Fonarow said.

The report was published in the April 11 issue of the Journal of the American Medical Association.

Heart failure, also called congestive heart failure, means the heart is unable to pump blood to the rest of the body the way it should.

For the study, Henrik Svanstrom, from the Statens Serum Institute in Copenhagen, and colleagues collected data on nearly 6,500 heart failure patients who had recently started taking losartan (4,397 patients) or candesartan (2,082 patients).

Both are a type of drug called angiotensin II receptor blockers (ARBs).

During follow-up, 2,378 participants died -- 330 taking candesartan and 1,212 patients taking losartan, the researchers found.

However, there was no significant increased risk of all-cause death or cardiovascular death associated with losartan compared to candesartan, the researchers said.

But dosage was important, the team said. The study found twice the risk of death with low-dose losartan compared to high-dose candesartan. Medium-dose losartan and low-dose candesartan also had a higher risk of death, but high-dose losartan had no increased death risk compared to high doses of candesartan.

"Our data provide a more detailed insight into the complexity of the association between losartan use and mortality risk in heart failure," the researchers concluded.

"These findings do not support the hypothesis of differential effects of specific ARBs in patients with heart failure," they added.

Dr. David Friedman, chief of heart failure services at North Shore-LIJ Health System's Plainview Hospital in Plainview, N.Y., said, "These medications are very helpful in heart failure patients."

Friedman noted that those in the losartan group were older and sicker, which may explain why more of them died.

These patients could only tolerate lower doses of losartan, and because they were sicker they were more likely to die than patients who could tolerate higher starting doses of candesartan, he said.

More information

For more on heart failure, visit the American Heart Association.

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Tax Day May Drive Up Fatal Crash Rates

HealthDay – 2 mins 43 secs ago TUESDAY, April 10 (HealthDay News) -- The upcoming income tax filing deadline might be taxing in more ways than one for Americans: A new study suggests that fatal crashes jump on Tax Day, possibly as a result of last-minute filers carelessly rushing to the post office to mail their returns.

The study's lead author said the research indicates that "stressful deadlines lead to driver distraction and human error."

"Almost all of these crashes could have been totally avoided by a small change in driver behavior. An awareness of this risk could lead to better road safety," said Dr. Donald A. Redelmeier, a professor of medicine at the University of Toronto.

But others who study traffic said it's hard to understand what the findings mean since other possibilities, such as more cars on the road, rather than lots of people too revved up to pay attention, could drive up crash statistics on Uncle Sam's big pay day.

"The problem with announcing that any one day has a greater-than-normal number of traffic crashes is that often, when adjusted for the higher number of travelers, the crash rate isn't actually higher than a typical weekend day," said Tom Vanderbilt, author of the book "Traffic: Why We Drive the Way We Do (and What It Says About Us)."

For the new study, published in the April 11 issue of the Journal of the American Medical Association, Redelmeier and a colleague examined a database of fatal U.S. traffic accidents from 1980 to 2009. They looked specifically at crashes on the date taxes were due and the same day the week before and the week after.

While the federal government's typical filing deadline is April 15, it falls on Tuesday, April 17, this year.

Although the risk of dying on Tax Day is extremely small, it's a bit higher than on the other days. The researchers found an average of 226 fatal accidents on annual tax-due days compared to 213 on the other days. The increased risk is about 6 percent.

Increased risk was greatest for people younger than 65, the researchers said.

Redelmeier, who has investigated traffic fatality rates on other special days, said Tax Day is about as risky on the roads as Super Bowl Sunday. In 2008, he also reported that fatal crashes are more likely during polling hours on presidential election days, compared to other Tuesdays around the same time.

He said he thinks stress is the accelerator here. "It doesn't just hold on Tax Day but might also hold to other distinctly stressful times, such as when you're going through a divorce or something is wrong with your child or you've just lost your job," he said.

Chandra Bhat, a professor of transportation engineering at University of Texas at Austin, raised questions about the study. For one thing, he said, the study finds that people under the age of 18 are involved in more fatal crashes on Tax Day. It's not clear if they're passengers or drivers, he said, adding that if they're drivers, it's unlikely the crash increase is related to the tax deadline.

"Traffic accidents are such relatively rare events that a one-day period of observation may be inadequate to make conclusive observations," Bhat cautioned. "While I appreciate that the analysis design followed by the authors is quite good and that the authors have considered several years in their analysis, I still would be somewhat cautious in drawing conclusions."

Since the study didn't account for factors such as sleep deprivation, the authors recommend additional research that would ultimately beef up efforts aimed at prevention.

For now, they said, drivers should be reminded to wear seat belts, drive the posted speed limit and avoid alcohol on April 17.

More information

For more about traffic safety, see the U.S. National Library of Medicine.

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Sibling Had a Stroke? Your Risk Might Rise, Too

HealthDay – 4 mins 42 secs ago TUESDAY, April 10 (HealthDay News) -- One clue to your risk for a stroke may come from a look at your siblings' experience with the brain attacks, a new study says.

People whose brother or sister had a stroke were up to 64 percent more likely to suffer one, compared to folks without such family histories, Swedish researchers report.

The risk rose even higher when the stroke to the sibling occurred when he or she was relatively young. For example, when a sibling had a stroke before the age of 56, their brother or sister's risk for a stroke nearly doubled, the study found.

The findings refer to the most common kind of stroke -- so-called ischemic stroke -- which occurs when blood flow is cut off to the brain as a result of a blood-vessel blockage.

"Patients in the risk zone of getting a heart attack or a stroke should be made aware that a genetic predisposition exists," said study lead author Dr. Erik Ingelsson, a professor of cardiovascular epidemiology at the Karolinska Institute, in Stockholm.

Still, that does not mean that you're doomed to suffer a stroke if your sibling did, Ingelsson added. "The increased familial risk may not solely be due to genetics," he said. "Similar lifestyle within families could also be involved -- and lifestyle can of course be modified."

The findings are published April 10 in Circulation: Cardiovascular Genetics.

Roughly 700,000 Americans experience an ischemic stroke every year, according to the American Heart Association.

To get a handle on sibling-associated stroke risk, the Swedish team pored through Swedish hospital discharge data and death registries for the period between 1987 and 2007.

The information included more than 30,700 men and women whose siblings had experienced a stroke, as well as another roughly 152,000 adults with no history of sibling stroke.

The results: Those whose brother or sister had had a stroke were between 61 and 64 percent more likely than those with no such family history to have one themselves.

Those whose half-brother or half-sister had had a stroke faced a 41 percent greater chance of having a stroke.

And those whose siblings had a stroke at the age of 55 or younger faced a 94 percent bump in their own stroke risk -- a nearly doubling of risk.

Gender did not appear to play a role in the degree to which sibling stroke history affected one's own risk.

The study authors stressed that they only looked at stroke incidence and did not explore family histories for any underlying risk factors, such as high blood pressure or cholesterol levels. That means they could not break down the degree to which genetic factors influenced stroke risk, versus the role played by nurture -- a shared upbringing.

However, "if your sibling has had a stroke, it may be a good idea to pay more attention to lifestyle habits such as diet and exercise, and to have your blood pressure checked at regular intervals," Ingelsson advised.

Dr. Gregg Fonarow, a professor of cardiology at the University of California, Los Angeles, said the study was "helpful" in better understanding stroke risk.

"This gives us insight into family risk, which involves both genetics, in terms of high blood pressure and high cholesterol risk, as well as a history of shared lifestyles," he said.

"Clearly, those with a first-degree relative who has had a stroke earlier in life are at much higher risk themselves, and should be seeking to address all the modifiable risk factors for a stroke," Fonarow added.

Dr. Murray Mittleman, director of the cardiovascular epidemiology research unit at Beth Israel Deaconess Medical Center in Boston, said: "Although you can't control your and your sibling's past history, you can control your current risk through lifestyle interventions.

"That would mean quitting smoking if you're a smoker," he said. "Getting your blood pressure checked and controlling it with medications so it's at a safe level. Maintaining an active lifestyle. And eating a heart-healthy diet with a good balance of healthy fats, fresh fruits and vegetables, and a reasonable amount of fiber."

More information

Find out more about stroke at the National Stroke Association.

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U.S. Spends Too Little on Public Health Initiatives: Report

HealthDay – 4 mins 40 secs ago TUESDAY, April 10 (HealthDay News) -- The United States needs to spend more on its chronically underfunded public health system and use that money more efficiently, according to an Institute of Medicine report released Tuesday.

The United States spends more on health than any other nation -- nearly $2.5 trillion in 2009 -- but has lower scores on life expectancy, infant survival and other indicators of population health than other wealthy nations, according to the report.

Public health department initiatives, services and expertise can help prevent or decrease rates of chronic diseases that account for the bulk of rising U.S. health spending, the authors report.

However, only 3.1 percent of U.S. health spending went to government-administered public health in 2009, according to the U.S. Centers for Medicare and Medicaid's National Health Expenditure Accounts. That works out to $251 per person in public health spending, compared with $8,086 per person in medical care spending.

The report calls for the U.S. Department of Health and Human Services to establish new goals for life expectancy and per-person health spending. The hope is that setting targets will motivate public health and medical care professionals to work together to maximize the value of health spending, and that public health skills and knowledge are used to address some of the biggest issues facing the larger health care system, such as the unnecessary use of medical procedures.

To achieve efficient use of public health dollars, the report recommended that the U.S. National Prevention, Health Promotion, and Public Health Council -- created by the Affordable Care Act -- should establish the minimum level of public health services every community should receive from its state and local health departments.

In addition, the council should create an expert panel to determine how much money is needed for every public health department to provide at least these minimum services, and to determine the proportion of federal health spending that needs to be spent in public health and medical care in order to get better value, the report said.

"Developing and implementing strategic population-based efforts to improve our health as a nation will increase the quality of life and productivity of Americans at the same time that it will contribute to moderating the expense of the clinical care system," report committee chair Dr. Marthe Gold, a professor and chair of the department of community health and social medicine at City College of New York, said in a National Academies news release.

"The country's failure to maximize the conditions in which people can be healthy continues to take a growing toll on the economy and on society. As the backbone of the health system, public health departments could help communities and other partners engage in efforts and policies that lead to better population health," Gold said.

More information

The U.S. Department of Health and Human Services has more about public health service agencies.

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Certain Birth Control Pills May Carry Higher Blood Clot Risk: FDA

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Short Walks May Ease Fatigue in Pancreatic Cancer Patients

HealthDay – 4 mins 34 secs ago TUESDAY, April 10 (HealthDay News) -- Regular walking can help reduce fatigue in some pancreatic cancer patients, a new study suggests.

The study included 102 white men and women aged 66 or 67 who underwent pancreatic cancer surgery and were divided into two groups just before they were discharged from the hospital.

One group was sent home with normal instructions that did not include a walking or exercise routine. The other group was told to walk for increasingly long intervals each week for three months. The goal was to walk 90 to 150 minutes per week by the end of the program.

At the start of the study, 85 percent of all patients reported moderate to severe fatigue. By the end of the study, improvements in fatigue levels were reported by 27 percent of those in the walking group and 19 percent of those in the control group. The patients in the walking group also reported less pain than those in the control group.

The study was published in the April issue of the Journal of the American College of Surgeons.

"The beauty of this program is that we're not asking for high-intensity aerobics or a target heart rate," lead author Theresa Yeo, an associate professor of nursing at Thomas Jefferson University School of Nursing in Philadelphia, said in a journal news release. "It's low to moderate intensity, and they can sit if they need to. They don't have to push through it if they are not feeling well that day."

Chronic fatigue affects up to 96 percent of people who are treated for cancer, according to the U.S. National Cancer Institute.

"The message in pancreatic cancer care has typically been that these patients are just too sick to do this, but that's not true anymore," Yeo said. "There is no reason that patients can't become active, even if they did not exercise before."

More information

The U.S. National Cancer Institute has more about fatigue in cancer patients.

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