Extended Breast-Feeding: Is It More Common than We Think?

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FDA warns MS patients about risky treatment

Reuters – 1 hr 36 mins ago WASHINGTON (Reuters) - U.S. drug regulators are warning people with multiple sclerosis that an experimental treatment that props open internal veins in the neck and chest can cause death or serious injury.

The Food and Drug Administration on Thursday said at least two people had died from the procedure, which uses stents or balloon angioplasties to widen veins that connect the brain and spinal cord to the heart. One person was permanently paralyzed, and others had bleeding in the brain, suffered strokes, blood clots or other side effects.

It is unknown how many people received the treatment and how many had problems, as stents and angioplasties are not approved for this use by the FDA, the agency said. Stents are steel mesh coils that can keep arteries open, while balloon angioplasties use a balloon at the tip of a catheter to open blocked blood vessels.

The FDA could not immediately identify the stent models being used in such treatments.

The FDA announcement relates to a controversy that has developed in the multiple sclerosis (MS) community about the causes of the chronic, progressive disorder of the brain and spinal cord.

The disease, which affects about 2.5 million people worldwide and has no cure, attacks the central nervous system and can lead to numbness, paralysis and loss of vision. Drugs that treat the condition, from companies like Biogen Idec Inc and Sanofi SA, can often only prevent relapses or slow its progression.

The underlying cause of MS is unknown. Some researchers believe that although it is typically thought of as a disorder of the immune system, it may actually be caused by blood vessel changes. Their theory is that veins bringing blood from the brain and spine back to the heart sometimes become too narrow, making blood leak back into the brain tissue. They say that could trigger inflammation, eventually causing the balance and muscle problems seen in MS.

Other scientists have not been able to show a link between MS and compromised blood flow, which is called chronic cerebrospinal venous insufficiency, or CCSVI, or prove the condition exists at all.

Meanwhile, MS patients seek new treatments, prompting patient advocacy and research groups to invest in more research studying the link between multiple sclerosis and CCSVI.

"Our position is that the evidence is simply insufficient to determine whether there's a link," said Dr. William Maisel, deputy director and chief scientist of the FDA's devices division. "We want patients to be aware this treatment (with stents or balloon angioplasty) is unproven, that there are significant risks associated with the treatment, (and) the benefits are uncertain."

The FDA said people who want to try the experimental treatment should first discuss the risks with their doctor, or should try the treatment while participating in clinical trials.

(Reporting by Anna Yukhananov; Editing by Michele Gershberg, Maureen Bavdek and John Wallace)

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Pot Belly Boosts Risk of Sudden Cardiac Death: Study

HealthDay – 1 hr 35 mins ago WEDNESDAY, May 9 (HealthDay News) -- A "spare tire" around the midsection raises the odds of sudden cardiac death in obese people, a new study finds.

A larger waist-to-hip ratio matters even more than body-mass index when it comes to sudden cardiac death risk, said study researcher Dr. Selcuk Adabag, an associate professor of medicine at the University of Minnesota in Minneapolis. Body-mass index is a measure of weight relative to height used to determine normal weight and obesity.

Obesity, a moderate risk factor for sudden cardiac death, and apple-shaped bodies often go hand in hand.

"The significance of this study is that it shows that abdominal obesity is an independent risk factor for sudden cardiac death, even after accounting for factors such as diabetes, hypertension and coronary heart disease," said Adabag, who is also a cardiac electrophysiologist at the Veterans Administration Medical Center in Minneapolis.

Adabag was scheduled to present the findings Wednesday at the annual meeting of the Heart Rhythm Society in Boston.

Sudden cardiac death is responsible for more than 250,000 deaths in the United States each year, according to the Centers for Disease Control and Prevention. It is defined as death that occurs within an hour of initial symptoms. Besides obesity, risk factors include coronary heart disease and heart rhythm problems.

For the study, Adabag looked at the records of more than 15,000 people with an average age of 54 from four U.S. locales who were enrolled in the Atherosclerosis Risk in Communities Study. Over 13 years, more than 300 of the participants experienced sudden cardiac death.

After Adabag took into account age, sex, race, education, smoking status and family history of heart disease, he found that body-mass index, waist circumference and waist-to-hip ratio all were linked with sudden cardiac death.

"I expected there would be some relationship with all

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Statins May Help Prevent Irregular Heartbeat in Elderly

HealthDay – 1 hr 35 mins ago WEDNESDAY, May 9 (HealthDay News) -- The widely used class of cholesterol-lowering medications known as statins may help elderly patients with high blood pressure avoid developing atrial fibrillation, a heart rhythm abnormality tied to stroke.

"Our study found that statin therapy in elderly patients with hypertension reduces the risk of new-onset atrial fibrillation," said Dr. Chen-Ying Hung, lead author of a study scheduled for presentation Wednesday at the Heart Rhythm Society's annual meeting in Boston.

But the findings are extremely preliminary and don't provide enough evidence to support this particular use of statins, such as Lipitor (atorvastatin) and Zocor (simvastatin) just yet, said the study authors and outside experts alike.

"We still need further studies to confirm this relationship before we can suggest statin use in

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Strides Made in Diagnosing, Treating Lupus

HealthDay – 1 hr 34 mins ago THURSDAY, May 10 (HealthDay News) -- Sometimes it takes years for people to get diagnosed with lupus. That wasn't the case for Marisa Zeppieri-Caruana, who had so many of the classic systemic lupus erythematosus symptoms -- such as a butterfly-shaped rash on her face, a daily fever and achy joints -- that her doctor knew right away that the 23-year-old had the illness.

Since then, Zeppieri-Caruana, now 34, has been hospitalized 30 times and has had four mini-strokes along with numerous other problems related to her lupus.

Most people who have lupus go through periods where they have active disease (flares) and periods where they don't have any symptoms (remission). Unfortunately, Zeppieri-Caruana said she's never had a time where she's been totally in remission.

"An average day for me includes fatigue and fever. It's really hard to try to put weight on, and I usually don't feel like doing anything. I have to take a nap every day," she explained.

"It's almost like I'm carrying a backpack all day long. Sometimes it's only 10 pounds, but sometimes it's much more. So even if I'm doing little things, it's like I'm doing them with an elephant on my back. It's exhausting carrying that extra load all the time," she said.

May 10 is World Lupus Day, a day designed to heighten awareness of this chronic autoimmune disease. About 1.5 million Americans have some form of lupus and worldwide that number is estimated to be about 5 million, according to the Lupus Foundation of America.

Lupus tends to strike women far more often than men. "The female-to-male ratio is nine to one and, in general, lupus is diagnosed in women of childbearing age," according to Dr. Howard R. Smith, a rheumatologist at the Cleveland Clinic, in Ohio.

However, progress is being made.

For example, many people are getting diagnosed sooner than they did in years past, said Dr. Kenneth Kalunian, a member of the Lupus Foundation of America's Medical-Scientific Advisory Council, and professor of clinical medicine at the University of California, San Diego School of Medicine. "Things are definitely improving in getting a diagnosis, but there's still a lag time in people with less specific symptoms. But it's markedly increased from just 10 years ago," he said.

Another expert explained why that time lapse can occur.

"Lupus can take a long time to recognize. It mimics many other diseases, and it's important to make sure a patient doesn't have an infection or a malignancy," said Dr. Michelene Hearth-Holmes, an assistant professor of internal medicine and rheumatology at the University of Nebraska Medical Center, in Omaha.

Most people with lupus will be fatigued, they may have a rash on their face across the bridge of the nose and cheeks, and many will have arthritis symptoms and frequent fevers. "Lupus can be a disease that affects patients from head to toe," Smith said. Areas it can affect include the skin, joints, kidneys, heart and blood vessels.

Along with getting a quick diagnosis, another tricky aspect of lupus is that it varies from person to person. "No two cases of lupus are alike. Each patient has to be treated as an individual. Symptoms can range from mild to life-threatening," Hearth-Holmes said.

There are a number of medications that can be used to treat lupus. Aspirin and other pain-relieving medications can help control some of the symptoms, as can corticosteroids. Another commonly recommended treatment is a drug called hydroxychloroquine (brand name Plaquenil) that was originally developed as a drug to combat malaria.

The most recent medication approved specifically for moderate to severe lupus with no kidney involvement is called belimumab (brand name Benlysta). This injectable medication modifies how the immune system works.

There are a number of other medications being developed or studied in trials that will alter the way the immune system works, according to the experts, and the hope is that newer drugs will be more effective and have fewer side effects.

"It's a very promising time in lupus research. It's reminiscent of where rheumatoid arthritis was 10 to 15 years ago when many patients ended up in wheelchairs. I don't see many rheumatoid arthritis patients in wheelchairs anymore," Kalunian said.

While the researchers are still working on better medications, there are some steps patients can take on their own. For example, all three doctors and Zeppieri-Caruana said that anyone with lupus should stay out of the sun as much as possible. And, if patients have to be outdoors, they should cover up with clothing, sunscreen, a hat and sunglasses. Sun, in addition to aggravating a lupus rash, can actually activate the disease in the rest of the body, according to Kalunian.

Smith said it's crucial that people don't smoke if they have lupus. "Smoking is terrible for lupus patients because there can be blood-vessel involvement."

Zeppieri-Caruana said she's noticed that what she eats makes a big difference in how she feels. She said red meat and fried foods, in particular, can aggravate her lupus. Smith said it's important to eat heart-healthy foods, such as fruits, vegetables and whole grains, because heart disease is increasingly being recognized as a risk for people with lupus.

It's also important to rest when needed. But, Hearth-Holmes said, this really varies from person to person. She said some people can work full time, while others find it exhausting. Her advice? "Limit yourself only as much as you want to limit."

Exercise can also help people with lupus stay in shape and stay more flexible. But, again, this will depend on the severity of the disease. Smith advised that even those with severe lupus should try to participate in some sort of activity. "Inactivity leads to problems on its own. Bones become thinner and it gets harder for people with swollen joints to move them," he said.

Zeppieri-Caruana also recommended joining a support group and seeing a therapist to talk about living with lupus. She said there are online groups available, which is very helpful when you're too tired to go out, but still need the support.

More information

Learn more about lupus and World Lupus Day from WorldLupusDay.org.

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Health Highlights: May 10, 2012

HealthDay – 1 hr 34 mins ago Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

Report Shows Questionable Billing by Thousands of U.S. Pharmacies

About $5.6 billion was paid by Medicare in 2009 to 2,600 pharmacies with questionable billings, according to a report released Thursday by the inspector general of the U.S. Health and Human Services department.

That included a Kansas drugstore that submitted more than 1,000 prescriptions each for two patients in that year, the Associated Press reported.

The analysis of more than 1 billion prescriptions submitted by the nation's 59,000 retail pharmacies in 2009 found that they're vulnerable to fraud. Part of the problem is that Medicare does not require private insurers that deliver prescription benefits to seniors to report suspicious billing patterns, the inspector general's report said.

"While some pharmacies may be billing extremely high amounts for legitimate reasons, all warrant further scrutiny," according to the document, which called for improved oversight, the AP reported.

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FDA Should OK New Rheumatoid Arthritis Pill: Panel

A new rheumatoid arthritis pill called tofacitinib should be approved for sale in the United States, a Food and Drug Administration advisory panel recommended Wednesday.

However, several members of the panel expressed concerns about the drug's safety and urged the FDA to require Pfizer to conduct rigorous follow-up studies, The New York Times reported.

In an 8-2 vote, the panel decided that tofacitinib could provide patients with an alternative to injectable medicines already on the market and that it offered enough benefits to offset potential safety risks, including higher rates of lymphoma and other cancers, and serious infections.

"The observation of malignancy rates increasing over time was unexpected and is of major concern," said panel member Dr. Nikolay P. Nikolov, The Times reported.

The FDA, which is expected to make a decision by August, typically follows the advice of its advisory panels.

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FDA Questions Long-Term Benefits of Bone Drugs

Bisphosphonate bone-strengthening drugs used to treat and prevent osteoporosis in older women may provide little long-term benefit, according to a U.S. Food and Drug Administration analysis of two previous studies that included more than 2,300 post-menopausal women.

The FDA found that the women "showed little benefit of continued bisphosphonate treatment beyond five years," Bloomberg News reported.

The agency didn't propose specific guidelines for doctors, but suggested that continued treatment with the drugs may provide some benefit to women with low bone-mineral density who have the highest risk of fractures.

The report, published in the New England Journal of Medicine, renews debate about whether taking bisphosphonates for longer than three to five years provides any protection against the risk of fractures, Bloomberg reported.

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Health Care Costs Top $240,000 for Retired Couples: Report

American couples retiring this year can expect their medical bills throughout retirement to cost about $240,000, which is about four percent more than the $230,000 needed by those who retired last year, says an annual projection released Wednesday by Fidelity Investments.

The new estimate is based on a 65-year-old couple retiring with Medicare coverage, and factors in the federal program's premiums, co-payments, deductibles and out-of-pocket prescription drug costs, the Associated Press reported.

The projection assumes the couple does not have insurance from their former employers and is based on a life expectancy of 85 for women and 82 for men. It doesn't include the costs of dental services or long-term care, such as the expense of living in a nursing home.

The most recent estimate could change significantly depending on the U.S. Supreme Court's ruling next month on whether to strike down part or all of the 2010 health care law. Depending on the ruling, Fidelity may update its estimate, the AP reported.

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Two Proposed Diagnoses Dropped From Psychiatric Diagnostic Manual

Two controversial proposals that would have expanded the number of people diagnosed with psychotic or depressive disorders have been scrapped by an expert panel revising an influential psychiatric diagnostic manual.

The panel working to complete the fifth edition of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders said the two proposed diagnoses were not supported by evidence, The New York Times reported.

The two rejected diagnoses were: attenuated psychosis syndrome, proposed to identify people at risk of developing psychosis; and mixed anxiety depressive disorder, a hybrid of anxiety and depression.

The panel also refined their proposed definition of depression so that the normal sadness a person experiences after the loss of loved one, marriage or job would not be mistaken for a mental health problem, The Times reported.

However, the panel did not back down from another widely criticized move to streamline the definition of autism. Critics say the new definition could greatly reduce the number of people diagnosed with autism, but panel members say evidence from a newly completed study shows that's not the case.

The changes to the diagnostic manual -- which plays a major role in research, treatment and insurance decisions -- are being debated this week at the psychiatric association's annual meeting, The Times reported.

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Health Tip: Do I Need the Meningococcal Vaccine?

HealthDay – 1 hr 34 mins ago (HealthDay News) -- The meningococcal vaccine helps prevent meningitis and sepsis (infection of the blood), which can lead to severe illness and death. People aged 16 through 21 are most likely to acquire meningococcal disease, the U.S. Centers for Disease Control says.

The agency says you probably should be vaccinated:

If you live in a dorm, or plan to live in one soon.If you are a military recruit.If you have a damaged spleen, or the organ has been removed.If you have a terminal complement deficiency.If you are a microbiologist who is frequently exposed to the bacterium Neisseria meningitidis.If you live in or plan to travel to a place where meningococcal infection is common.

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Health Tip: When Your Knee is Unstable

HealthDay – 1 hr 34 mins ago (HealthDay News) -- Your thighbone has a v-shaped notch that accommodates your kneecap. If the groove is too narrow or shallow, the knee cap can become unstable and dislocate.

The American Academy of Orthopaedic Surgeons says symptoms of an unstable kneecap include:

A buckling knee joint that can't support your weight.A kneecap that seems to slide to the side during movement.Pain in the front of your knee that worsens when you're moving.Stiffness, swelling or pain when you sit down.Cracking or creaking noises in your knee while you move.

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Gut Bugs Might Influence Child's Odds for Obesity

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Scleroderma Complications Worse in Blacks Than Whites: Study

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Many Women Still Smoke During Pregnancy

HealthDay – 1 hr 34 mins ago THURSDAY, May 10 (HealthDay News) -- Too many American women still smoke during their pregnancies, a new report finds, and rates of such smoking vary widely depending on race.

Researchers found that almost 22 percent of pregnant white women aged 15 to 44 smoked cigarettes within the previous 30 days, compared with just over 14 percent of pregnant black women and 6.5 percent of Hispanic women in the same age range.

The rate of illicit drug use during pregnancy, however, was higher among black women (7.7 percent) than among white women (4.4 percent) or Hispanic women (about 3 percent), according to the Substance Abuse and Mental Health Services Administration study, released Wednesday.

Rates of alcohol use during pregnancy were about the same for black and white women (12.8 percent and 12.2 percent, respectively), and much higher than among Hispanic women (7.4 percent), according to the study.

The findings are based on an analysis of data from the administration's 2002 to 2010 national surveys on drug use and health.

"When pregnant women use alcohol, tobacco or illicit substances they are risking health problems for themselves and poor birth outcomes for their babies," Pamela Hyde, administrator at the Substance Abuse and Mental Health Services Administration, said in a government news release.

"Pregnant women of different races and ethnicities may have diverse patterns of substance abuse," Hyde said. "It is essential that we use the findings from this report to develop better ways of getting this key message out to every segment of our community so that no woman or child is endangered by substance use and abuse."

More information

The March of Dimes has more about the dangers of drinking alcohol during pregnancy.

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FDA Issues Warning on Controversial MS Treatment

HealthDay – 1 hr 34 mins ago THURSDAY, May 10 (HealthDay News) -- Doctors and patients need to be aware of the potential risk of injuries and death associated with an experimental treatment for multiple sclerosis called liberation therapy, the U.S. Food and Drug Administration said in an alert issued Thursday.

Liberation therapy is used to treat chronic cerebrospinal venous insufficiency (CCSVI) -- a narrowing of veins in the neck and chest -- believed by some to cause multiple sclerosis (MS) or worsen the disease. They think it does so by impairing blood drainage from the brain and upper spinal cord.

The controversial procedure uses balloon angioplasty devices or stents to widen narrowed veins in the chest and neck. But the FDA has not approved this treatment for chronic cerebrospinal venous insufficiency, and the agency said it has learned of deaths, strokes, damage to the treated vein, blood clots, cranial nerve damage, abdominal bleeding, and migration of stents in the body as a result of the treatment.

Also, studies examining a possible link between the two conditions are inconclusive, and the criteria used to diagnose chronic cerebrospinal venous insufficiency have not been adequately established, the FDA said.

"Because there is no reliable evidence from controlled clinical trials that this procedure is effective in treating MS, FDA encourages rigorously conducted, properly targeted research to evaluate the relationship between CCSVI and MS," Dr. William Maisel, chief scientist and deputy director for science in the FDA's Center for Devices and Radiological Health, said in an agency news release.

"Patients are encouraged to discuss the potential risks and benefits of this procedure with a neurologist or other physician who is familiar with MS and CCSVI, including the CCSVI procedures and their outcomes," he added.

MS is a progressive autoimmune disease that affects the nervous system. Its underlying cause is unknown.

The FDA also is notifying doctors and clinical investigators who are planning or conducting clinical trials using medical devices to treat chronic cerebrospinal venous insufficiency that they must comply with FDA regulations for investigational devices.

Dr. Fred Lublin, director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai School of Medicine in New York City, welcomed the alert. "The FDA's action is well-founded and provides an important safeguard for individuals with MS," he said.

"There are safety issues with the procedures associated with CCSVI, as detailed in the FDA alert," Lublin said. He also said the very existence of chronic cerebrospinal venous insufficiency is unclear. And, "whether there is any relationship between CCSVI and MS, as either a cause or consequence, is unproven," he added.

Without scientific studies supporting the treatment of chronic cerebrospinal venous insufficiency in patients with MS, the procedure cannot be recommended, Lublin said.

More information

The American Academy of Family Physicians has more about multiple sclerosis.

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