(July 12) - In the month after a surprising analysis revealed possible heart risks from the blockbuster diabetes drug Avandia, reports of side effects to federal regulators tripled.
Avandia is used to control blood sugar for Type 2 diabetes. These people are already at higher risk of heart attacks.
The sudden spike is a sign that doctors probably were unaware of the drug's possible role in their patients' heart problems and therefore may not have reported many such cases in the past, several experts said.
It also shows the flaws of the safety tracking system and suggests that a better one might have detected a potential problem before the drug had been on the market for eight years.
Avandia is used to control blood sugar, helping more than 6 million people worldwide manage Type 2 diabetes , the kind that is linked to obesity. These people already are at higher risk for heart attacks, so news that the drug might raise this risk by 43 percent was especially disturbing.
In the 35 days after May 21, when the New England Journal of Medicine published the analysis on the Internet, reports of heart attacks, deaths and hospitalizations leaped. The sharp rise in reports of heart problems appears in data obtained by The Associated Press through a Freedom of Information Act request to the federal Food and Drug Administration.
Only five heart attacks were reported in the 35 days before the study, compared with 90 in the same period afterward. Heart-related hospitalizations went from 11 to 126. The reports involve rosiglitazone, sold as Avandia and Avandamet.
Reporting a drug's side effects is voluntary, and only a crude indication rather than a scientific measure of how many problems patients are actually having. The FDA relies on this unenforced system once a drug is on the market. Critics say it leads to haphazard oversight in which problems can be missed because doctors don't connect the dots between a drug and symptoms they see in an individual patient.
With Avandia, the published analysis likely led to more cases being reported, said Vanderbilt University diabetes specialist Dr. Alvin C. Powers.
"Now, patients and their doctors are much more aware of the possible link between Avandia and cardiovascular disease. This is good _ this is going to help us going forward to determine whether or not this drug is safe," he said.
The drug's manufacturer, British-based GlaxoSmithKline PLC, insists that the drug is safe and effective.
"This is a very well-known phenomenon," where news reports lead to increased reporting, said company spokeswoman Mary Anne Rhyne. "It's good that there's awareness of the reporting system, but drawing conclusions on such data is inappropriate."
The FDA plans hearings on safety concerns about the drug on July 30. In the meantime, diabetes experts have advised users of the medication to talk to their doctors and not to immediately discontinue it.
The side effects reported range from as minor as a blister to as serious as sudden cardiac death. Most of the reports the AP reviewed seemed to involve serious side effects, and rosiglitazone was listed by the FDA as the "primary suspect" rather than other medicines the patient may have been taking.
There was a total of only 50 adverse event reports in January and 73 in February. From April 16 to May 21, when the study was published, 121 events were reported, including 11 deaths. In the 35 days after the study, 357 events were reported, including 38 deaths.
"You really can't infer anything about incidence rates from that," because the spike in reports is likely due to the "publicity effect" of the study, said Dr. David Graham, an FDA drug safety expert.
Dr. David Nathan, chief of diabetes care at Massachusetts General Hospital, agreed, saying it was "not conceivable" that only five people among the 1 million Americans taking Avandia had heart attacks in the month preceding the May 21 study, as the FDA reports suggest.
"It just heightens the concern about the poor reporting we have," said Nathan, who has received speaker fees from Glaxo and other drug companies. Powers and Graham have no financial ties to any diabetes drug makers.
The issue has roiled the medical community and sparked congressional probes into whether the FDA is properly investigating safety issues. The FDA issued a "safety alert" about the drug only after the May 21 study came out, even though Glaxo had informed the agency of its own analysis of heart risks nearly a year beforehand and possibly as early as 2005.
Avandia's label warns about possible heart failure and other heart problems when taken with insulin. The drug also raises LDL, or bad cholesterol, and can cause fluid retention and weight gain.
Never, put your banana in the refrigerator!!!
This is interesting.After reading this, you'll never look at a banana in the same way again.
Bananas contain three natural sugars - sucrose, fructose and glucose combined with fiber. A banana gives an instant, sustained and substantial boost of energy.
Research has proven that just two bananas provide enough energy for a strenuous 90-minute workout. No wonder the banana is the number one fruit with the world's leading athletes.
But energy isn't the only way a banana can help us keep fit.It can also help overcome or prevent a substantial number of illnesses and conditions, making it a must to add to our daily diet.
Depression: According to a recent survey undertaken by MIND amongst people suffering from depression, many felt much better after eating a banana. This is because bananas contain tryptophan, a type of protein that the body converts into serotonin, known to make you relax, improve your mood and generally make you feel happier.
PMS:Forget the pills - eat a banana. The vitamin B6 it contains regulates blood glucose levels, which can affect your mood.
Anemia: High in iron, bananas can stimulate the production of hemoglobin in the blood and so helps in cases of anemia.
Blood Pressure: This unique tropical fruit is extremely high in potassium yet low in salt, making it perfect to beat blood pressure. So much so, the US Food and Drug Administration has just allowed the banana industry to make official claims for the fruit's ability to reduce the risk of blood pressure and stroke.
Brain Power: 200 students at a Twickenham (Middlesex) school were helped through their exams this year by eating bananas at breakfast, break, and lunch in a bid to boost their brain power. Research has shown that the potassium-packed fruit can assist learning by making pupils more alert.
Constipation: High in fiber, including bananas in the diet can help restore normal bowel action, helping to overcome the problem without resorting to laxatives.
Hangovers: One of the quickestways of curing a hangover is to make a banana milkshake, sweetened with honey. The banana calms the stomach and, with the help of the honey, builds up depleted blood sugar levels, while the milk soothes and re-hydrates your system.
Heartburn:Bananas have a natural antacid effect in the body, so if you suffer from heartburn, try eating a banana for soothing relief.
Morning Sickness: Snacking on bananas between meals helps to keep blood sugar levels up and avoid morning sickness.
Mosquito Bites: Before reaching for the insect bite cream, try rubbing the affected area with the inside of a banana skin. Many people find it amazingly successful at reducing swelling and irritation.
Nerves: Bananas are high in B vitamins that help calm the nervous system.
Overweight and at work? Studies at the Institute of Psychology in Austria found pressure at work k leads to gorging on comfort food like chocolate and crisps. Looking at 5,000 hospital patients, researchers found the most obese were more likely to be in high-pressure jobs. The report concluded that, to avoid panic-induced food cravings, we need to control our blood sugar levels by snacking on high carbohydrate foods every two hours to keep levels steady.
Ulcers: The banana is used as the dietary food against intestinal disorders because of its soft texture and smoothness. It is the only raw fruit that can be eaten without distress in over-chronicler cases. It also neutralizes over-acidity and reduces irritation by coating the lining of the stomach.
Temperature Control: Many other cultures see bananas as a "cooling" fruit that can lower both the physical and emotional temperature of expectant mothers. In Thailand , for example, pregnant women eat bananas to ensure their baby is born with a cool temperature.
Seasonal Affective Disorder (SAD): Bananas can help SAD sufferers because they contain the natural mood enhancer tryptophan.
Smoking &Tobacco Use: Bananas can also help people trying to give up smoking. The B6, B12 they contain, as well as the potassium and magnesium found in them, help the body recover from the effects of nicotine withdrawal.
Stress: Potassium is a vital mineral, which helps normalize the heartbeat, sends oxygen to the brain and regulates your body's water balance. When we are stressed, our metabolic rate rises, thereby reducing our potassium levels. These can be rebalanced with the help of a high-potassium banana snack.
Strokes: According to research in The New England Journal of Medicine, eating bananas as part of a regular diet can cut the risk of death by strokes by as much as 40%!
Warts: Those keen on natural alternatives swear that if you want to kill off a wart, take a piece of banana skin and place it on the wart, with the yellow side out. Carefully hold the skin in place with a plaster or surgical tape!
So, a banana really is a natural remedy for many ills. When you compare it to an apple, it has four times the protein, twice the carbohydrate, three times the phosphorus, five times the vitamin A and iron, and twice the other vitamins and minerals. It is also rich in potassium and is one of the best value foods around So maybe its time to change that well-known phrase so that we say, "A banana a day keeps the doctor away!"
PASS IT ON TO YOUR FRIENDS
PS: Bananas must be the reason monkeys are so happy all the time! I will add one here; want a quick shine on our shoes?? Take the INSIDE of the banana skin, and rub directly on the shoe ... polish with dry cloth. Amazing fruit !
Why you cannot put bananas in the refrigerator
Basically, putting bananas in the refrigerastor will stop the ripening process.
It depends on the state you bought them in and the way you like them. In your grocery store you may find bananas that are green-tipped, full yellow, or yellow with brown spots. All of these bananas are ready to eat. Bananas with a yellower skin color have a sweeter flavor. Bananas are fully ripened when brown spots appear on the peel. These bananas have a softer texture and are very sweet.
The further ripen bananas. take them out of the plastic produce bag and store them at room temperature. The bananas will continue to ripen. Storing bananas on a banana hanger or hook is the best way to preserve the overall quality of a ripe banana as it avoids "resting bruises." Store bananas away from doors, windows, exterior walls, and cold or hot drafts. If your bananas are too green, you can put them in a paper bag to ripen. If you add an apple or tomato to the bag, the bananas will ripen even faster.
Now, back to the question. When the bananas get to the desired ripeness, just put them into your refrigerator. The skin turns black, but the banana inside stays perfect for two or three days. Never store unripe bananas in the refrigerator! They simply will not ripen properly because the cold interferes with the ripening process.
I read somewhere the best way for storing bananas is to peel them, put them in a plastic box as a whole and refrigerate them, and they'll keep well for more than 2 weeks, losing none of their taste or texture. I can 't confirm this though, haven't tried it yet.
You can also peel bananas, cut them in chunks, freeze them and eat them as a frozen treat, reminiscent of ice cream. You can also take those frozen chunks and make a very creamy smoothie using fat free rice milk or soymilk and a little flavoring.
Margarine was originally manufactured to fatten turkeys.
When it killed the turkeys, the people who had put all the money into the research wanted a payback so they put their heads together to figure out what to do with this product to get their money back.
It was a white substance with no food appeal so they added the yellow coloring and sold it to people to use in place of butter. How do you like it? They have come out with some clever new flavorings.
DO YOU KNOW...the difference between margarine and butter?
Read on to the end...gets very interesting!
Both have the same amount of calories.
Butter is slightly higher in saturated fats at 8 grams compared to 5 grams.
Eating margarine can increase heart disease in women by 53% over eating the same amount of butter, according to a recent Harvard Medical Study.
Eating butter increases absorption of many other nutrients in other foods.
Butter has many nutritional benefits where margarine has a few only because they are added!
Butter tastes much better than margarine and it can enhance the flavors of other foods.
Butter has been around for centuries where margarine has been around for less than 100 years.
And now, for Margarine...
Very high in trans fatty acids.
Triple risk of coronary heart disease.
Increases total cholesterol and LDL (this is the bad cholesterol) and lowers HDL cholesterol, (the good cholesterol)
Increases the risk of cancers up to five fold.
Lowers quality of breast milk
Decreases immune response.
Decreases insulin response.
And here's the most disturbing fact....
HERE IS THE PART THAT IS VERY INTERESTING!
Margarine is but ONE MOLECULE away from being PLASTIC...
This fact alone was enough to have me avoiding margarine for life and anything else that is hydrogenated (this means hydrogen is added, changing the molecular structure of the substance).
You can try this yourself:
Purchase a tub of margarine, leave it in your garage or shaded area.
Within a couple of days you will note a couple of things:
* No flies, not even those pesky fruit flies will go near it (that should tell you something)
* It does not rot or smell differently because it has no nutritional value
* Nothing will grow on it. Even those teeny weenie microorganisms will not a find a home to grow.
Why? Because it is nearly plastic.
Would you melt your Tupperware and spread that on your toast?
Share This With Your Friends..... (If you want to "butter them up")!