Month: July 2008

"The new language will strengthen the existing warnings," said Dr. Edward Cox, director of the FDA's Office of Antimicrobial Products.

The FDA is requiring the label warnings and a medication guide for fluoroquinolone drugs, which include Cipro, Levaquin, Avelox, Noroxin and Floxin.

The consumer group Public Citizen asked the FDA in August 2006 to put the "black box" warning on Cipro and other fluoroquinolones, and also to warn doctors. Earlier this year, Public Citizen filed a lawsuit to force the FDA to take those actions.

When asked about the lawsuit and why it took so long to add the label warning, Cox stressed that the FDA included warning information with the drugs from 2001 until 2004, and updated the information last year.

"There has been ongoing work to update the labeling of the fluoroquinolone drug products," Cox said. "We have been working on this issue and making progress over time."

The companies that make the fluoroquinolone drugs will be required to submit label safety changes and the medication guide within 30 days of receiving the notification from the FDA or provide a reason why they do not believe such labeling changes are necessary, Cox said.

The fluoroquinolones drugs can increase the risk of tendonitis and tendon rupture — which is about 1 in 100,000 — by three to four times, according to the FDA's Dr. Renata Albrecht.

"This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy," the FDA said in a statement.

Albrecht said that sometimes patients have no symptoms before they experience a rupture in their tendon — commonly their Achilles tendon.

"Sometimes it's been reported on the first day of taking a fluoroquinolone … a sudden snap or popping sound that is tendon rupture with no preceding warning," she said.

Normally, she added, that patients experience some pain or inflammation "a week or two before the patient will rupture."

The FDA would only say that it has received "hundreds" of reports of tendon problems linked to fluoroquinolones, without being more specific, citing the ongoing lawsuit. But Cox said "the FDA continues to receive a considerable number of reports on tendon adverse effects."

Patients should stop taking fluoroquinolone antibiotics at the first sign of tendon pain, avoid exercise and contact their doctor, the FDA said.

Cox said the FDA would not require companies to send letters to doctors alerting them about the connection between tendon problems and the antibiotics.

AN estimated one in 10 middle-aged Malaysians has diabetes. But that's not what worries experts the most. Another one in five has what doctors call "pre-diabetes".

The number of pre-diabetics is expected to climb as the nation gets older, fatter and more sedentary.

Pre-diabetics are not only at risk of developing diabetes but are also at risk of suffering heart attacks, strokes, kidney failure, blindness and nerve damage.

"Your risk of heart attack or stroke is two to four times higher if you have diabetes. It is 1 1/2 times higher if you have pre- diabetes," says Judith Fradkin of the National Institute of Diabetes & Digestive & Kidney Diseases in the United States.

"Between a third and half of pre-diabetics will go on to develop diabetes within five or 10 years," says Frank Vinicor, director of the Diabetes Programme at the Centres for Disease Control and Prevention in Atlanta, USA.

Insulin Resistance

Pre-diabetes and Type II diabetes usually begin with insulin resistance. Blood sugar (glucose) level in the body is regulated by insulin, a hormone produced in the pancreas. Insulin helps to transport glucose from the blood through the cell membranes and into the cells of the body.

As long as the cell membranes remain sensitive to insulin, the shuttling of glucose to the cells occurs quickly.

When the cell membranes become insensitive to insulin (also called insulin resistance), the pancreas will have to pump out more insulin to force the glucose into the cells.

When this doesn't work, the result is high levels of sugar in the blood (considered a pre-diabetes condition).

Over time, the pancreas no longer produces enough insulin to control blood sugar and Type II diabetes develops.

Researchers now know that diabetes does not just happen. Before you get diabetes, you'd have a condition known as pre-diabetes where your blood sugar is higher than normal but not high enough to be termed diabetes.

If you are told that you fall into the pre-diabetes range, it is not such a bad news after all.

People with pre-diabetes can lower their risk of getting diabetes by nearly 60 per cent through healthy eating, regular exercise and taking supplements to prevent or delay the onset of diabetes and reduce the risk of complications.

CINNAMON EXTRACT : When Dr Richard Anderson, a chemist at the US Department of Agriculture, was searching for foods that might mimic the action of insulin in controlling blood sugar (glucose) levels, he found a class of water-soluble compounds in cinnamon called Polyphenol Type-A polymers. This can help boost insulin activity about 20 fold.

Water-soluble cinnamon polyphenol Type A polymers extract is 70 per cent more effective than whole cinnamon.

BANABA EXTRACT: A number of medicinal plants from India, China and Japan are used for diabetes. One of the most effective plant compounds discovered is corosolic acid from the leaves of the banaba (Lagestroemic speciosu) tree, which exhibits antidiabetic properties.

Corosolic acid acts like insulin. The hormone that naturally increases glucose transport activity across cell membranes thus facilitates the lowering of blood sugar.

Clinical studies in the US and Japan show that corosolic acid is safe and effective in lowering blood sugar levels in pre-diabetes and Type II diabetes.

If you are at risk of pre-diabetes, take a blood test. Even if you don't consider yourself at risk, it is still advisable for those over 35 years of age to check their blood sugar levels annually.

Most of the studies on cinnamon use the water-soluble extract standardised to contain Trimeric and Tetrameric A-Type Polymer (polyphenol Type A polymer) and as for banaba, it is standardised to contain one per cent corosolic acid.

Insulin Support 

By Ed Edelson

TUESDAY, July 8 (HealthDay News) — A seldom-used test that measures blood pressure in the ankle and the arm can help improve assessment of the risk of heart disease, stroke and other cardiovascular problems, an international research group reports.

It has a distinct advantage in that it is extremely easy to perform and doesn't require expensive, sophisticated equipment, Gerry Fowkes, a professor of epidemiology at the University of Edinburgh, Scotland, said of the ankle brachial index (ABI). The device is the subject of a report in the July 9 issue of the Journal of the American Medical Association. The index is the ratio between the blood pressure measurements in the ankle and the arm.

The ABI should be used to supplement rather than replace standard measures of cardiovascular risk such as cholesterol, blood pressure, obesity and physical activity, Fowkes said.

"It has been shown that using these common risk factors, prediction is not as good as it might be," he said. "That is why we and others have been looking for other factors to improve prediction."

The meta-analysis used data from 16 studies around the world, including 24,955 men and 23,339 women who were followed after an initial ABI measurement. Over the next 10 years, 4.4 percent of men with a normal ABI died, compared to 18.7 percent of men with an abnormally low ABI. Death rates for women were 12.6 percent for those with a low ABI, 4.1 percent for those with a normal ABI.

A lower ABI was associated with approximately a doubled risk of death from any cause, cardiovascular death, and a major coronary event over the 10 years, the report said. Including the ABI in current risk factor assessments would mean reclassification of cardiovascular risk and change of the measures taken to prevent cardiovascular events for 19 percent of men and 36 percent of women, the researchers estimated.

Studies about the use of the ABI are continuing, Fowkes said. "The next step is to look at the prediction made by combining the ABI and other risk factors," he said. "Any individual who is having a cardiovascular risk assessment would benefit from having this test, but when we have done further work in looking at the detailed accuracy of the prediction, proper use of the test will become more obvious."

ABI testing right now isn't for everyone, said Dr. Aaron B. Folsom, a professor of epidemiology at the University of Minnesota, and a member of the research team.

It is being promoted as a way of measuring the risk of peripheral arterial disease (PAD), blockage of blood vessels in the legs, and so it is best used for older people, who are at greater risk of PAD, Folsom said. Wider use can be proposed, because "the more information you have, the better you do in classifying cardiovascular risk," Folsom said.

A low ABI reading would mean greater emphasis for that individual on the classic risk factors — blood cholesterol, blood pressure, diabetes, obesity and the others, Folsom added. "We do have interventions that we know work, such as glucose-lowering and physical activity," he said.

After all the excitement and over-indulging during the Fourth of July weekend, it's time to get healthy!

An article in the NY Times opened our eyes to foods we should not only be eating, but also feeding our families. Dr. Bowden, author of The 150 Healthiest Foods on Earth, gives his advice for the 10 foods you should be consuming on a regular basis.

	Beets Not always a favorite with kids, but it's the best one for you. Beets are a rich source of folate and a natural red pigment that is known to be a cancer fighter. Dr. Bowden suggests: Eat beets roasted, raw, or in a salad.
	Cabbage It's packed with nutrients such as sulforaphane, a chemical that boosts cancer-fighting enzymes. Dr. Bowden suggests: Eat it in a slaw, or top off your burger or sandwich with it.
	Swiss Chard This leafy vegetable is loaded with caroteniods, which strengthen eyesight over time. Dr. Bowden suggests: Chop and saute in olive oil. You can also incorporate other vegetables into your saute.
	Cinnamon For people with high cholesterol or problems with their blood sugar, cinnamon may help control it. Dr. Bowden suggests: Cinnamon can be sprinkled on coffee, oatmeal, cereal or baked goods.
	Pomegranate Juice Pomegranate juice is delicious, packed with antioxidants, and appears to lower blood sugar. Dr. Bowden suggests: Drink it! Simple as that.
	Dried Plums These are actually prunes, but some get turned off just by that word, so dried plums it is. Prunes contains cancer-fighting antioxidants. Dr. Bowden suggests: Wrap the dried plums in prosciutto and bake.
	Pumpkin Seeds You don't need to wait until Halloween to get your kids to eat these. Pumpkin seeds are packed with magnesium and the high levels of mineral are associated with a lower chance for early death. Dr. Bowden suggests: Roast these with your kids or sprinkle on a salad.
	Sardines You may think "yuck," but sardines are full of iron, magnesium, phosphorus, potassium, zinc, copper, and vitamin B that your body needs. Dr. Bowden suggests: Buy sardines packed in olive or sardine oil. If you're gutsy, attempt to eat them plain, on a salad, or on toast.
	Turmeric Dr. Bowden refers to this as the "superstar of spices." It contains anti-cancer and anti-inflammatory properties. Dr. Bowden suggests: Spice up your scrambled eggs or any vegetable dish with turmeric.
	Frozen Blueberries It's possible that blueberries can strengthen your memory, or so says a round of animal tests. You can find frozen blueberries all year round. Dr. Bowden suggests: Blend with yogurt or soymilk to make a tasty smoothie.

By Katherine Hobson

There's a reason so many doctors and nutritionists recommend keeping a food diary when you're trying to lose weight: It actually appears to work. 

It's simple. No fancy machines required; just record what you eat on paper or using an online record. "The trick is to write down everything you eat or drink that has calories," says Victor Stevens, a researcher at Kaiser Permanente's Center for Health Research and coauthor of the study released today, which appears in the American Journal of Preventive Medicine. That's easy enough with labeled foods but gets harder when you're dining out or are eating an unfamiliar food. Try online calorie databases like CalorieKing.com, and watch the serving sizes—here's a good source of info on estimating what, say, an ounce of bread looks like. You'll probably still underestimate your daily intake, says Thomas Wadden, director of the Center for Weight Loss and Eating Disorders at the University of Pennsylvania School of Medicine, but you'll very likely come closer than someone who isn't keeping a food record.

It's eye opening. In fact, some people will be so shocked at how many calories are in their thrice-daily Coke that the "aha" moment will make going on an actual diet unnecessary. Being forced to be aware of what you're eating can often be enough to help people drop weight, says Wadden.

It helps you track your progress. Use the diary as a way to make adjustments throughout the day and to gauge how much exercise you need to hit a certain calorie count, advises Holly Wyatt, a physician and researcher at the Center for Human Nutrition at the University of Colorado Health Sciences Center. "If I eat three cups of fries, I know that I ate a lot and can cut back at the next meal," says Francis Tacotaco, a 38-year-old skilled nursing assistant from Richmond, Calif., who used a food diary as part of a weight-loss program at Kaiser. He's lost 21 pounds so far and wants to drop more.

You're accountable to someone. Supervised weight-loss programs often require participants to turn in their food diaries to nutritionists or doctors, which may make you think twice before giving in to temptation. "I've seen it all," says Stevens. "One gallon of vanilla ice cream, three pizzas, and a gallon of milk. My experience is that the people who have the courage to write it down tend to do pretty well," even if what they're writing down amounts to a lot of food, he says. If you're not part of a program, you can team up with a friend and swap food diaries once a week to keep each other in line. And many people find it's enough to be accountable to themselves. "You won't put that second cookie in your mouth because you don't want to see it in your food record," says Stevens.

After the extra poundage is gone, many people continue to use a diary to keep themselves honest. About 50 percent of participants in the National Weight Control Registry (which tracks the habits and practices of weight-loss maintainers) report they use some kind of self-monitoring, such as a food diary, says Wyatt. Some people may keep a diary on the weekend only, when they tend to eat more; others just record dinner, which usually varies more than breakfast and lunch, says Wadden. It's a habit you can benefit from for a lifetime.