Abbott Laboratories is retirement of the obesity Drug Meridia

SILVER SPRING, Maryland, October 8,/PRNewswire-USNewswire/--Abbott Laboratories has accepted the voluntary obesity drug Meridia (sibutramine) to pull out of the American market because of the clinical trial data that an increased risk of heart attack and stroke, the u.s. food and drug administration, announced today.

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"Meridia continued availability is not justified when you compare the very modest weight loss that people on this drug their risk of heart attack or stroke," said John Jenkins, m.d., Director of the Office of the new drugs in the FDA Center for Drug Evaluation and Research (CDER)."Doctors are advised to stop to prescribe Meridia to their patients and patients should stop taking this medication. patients should talk with their health care provider about alternative weight loss and maintenance programs of the loss of weight."

Meridia in november 1997 was approved by the FDA for weight loss and maintenance of weight loss in obese people, as well as in some overweight people with other risks for heart disease.The approval is based on clinical data showing that more people received sibutramine lost at least 5% of their body weight than people on placebo that are on a diet and exercise alone.

The FDA requested the market after reading of data from the Sibutramine BOY SCOUTS (cardiovascular outcomes trial). SCOUTING has been set up as part of a postmarket cardiovascular safety of sibutramine requirement after a look to the European approval of these drugs. the process demonstrated an increase of 16% of the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated as soon as the heart stopped and dead, who in a group of patients receive sibutramine in comparison with other placebo. There was a slight difference in the weight loss between the placebo group and the group that received sibutramine.

"The patients in the European Scouting process do not have the same features as the patients the approved indication in the United States, but these results, in combination with other available safety data serious questions about Meridia of security for all groups of patients," said Gerald Valley Pan, MD, m.h.s., Director of the Office of the surveillance and epidemiology in CDER.

The analysis of the Agency is of the Scout movement was the subject of the FDA is Endocrinologic and metabolic Drugs Advisory Committee meeting on 15 September.

For more information:

Drug Safety: FDA recommends that communication against the continued use of Meridia (sibutramine)

http://www.fda.gov/drugs/drugsafety/ucm228746.htm

Media questions about:

Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov

Erica Jefferson, 301-796-4988; erica.jefferson@fda.hhs.gov

Consumer questions about: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

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Diabetes drug Avandia suspended

The diabetes drug Avandia, also known as rosiglitazone, has been suspended by UK and European drug watchdogs. The drug, which is used to control blood sugar in type 2 diabetes, has been linked to an increased risk of heart attack and stroke.In light of these risks, both the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have recommended that the drug is no longer prescribed. This prescribing ban also applies to Avandamet and Avagl im, two related drugs also containing rosiglitazone.

Up until now diabetes drugs containing rosiglitazone have been considered when diabetes cannot be controlled using either of the first-choice medications, metformin and sulphonylurea. The heart risk has been recognised for some time, with previous rulings by the MHRA saying that the drugs should not be used in people with heart failure or cardiovascular disease. However, continuing research into the safety of the drug has now led an advisory committee of the EMA to call for rosiglitazone to be withdrawn altogether. It echoes similar moves by the US Food and Drug Administration (FDA), which has recently placed tight restrictions on rosiglitazone drugs.

What is rosiglitazone, or Avandia?Rosiglitazone is a drug designed to help control type 2 diabetes by reducing the body’s resistance to insulin, ie allowing insulin to do its normal job of reducing blood glucose levels.

It is not a first-choice (first-line) diabetes medication, but until now it has been used to treat some patients who do not have adequate blood sugar control when taking the first-choice medications – metformin, a sulphonylurea drug or a drug combining both. In these cases rosiglitazone may be prescribed, either on its own or in combination with metformin or a sulphonylurea drug.

Rosiglitazone has also been prescribed for people already taking the combination of metformin and a sulphonylurea drug, but who need extra blood sugar control and cannot take insulin.

Rosiglitazone is supplied under the brand name Avandia, manufactured by GlaxoSmithKline. Rosiglitazone is also found in a drug called Avandamet, which combines rosiglitazone with metformin. Avandamet is subject to the same suspension as Avandia. Rosiglitazone is also found in the drug Avaglim, though this drug is not licensed for use in the UK.

Rosiglitazone was introduced in July 2000. There are currently an estimated 55,300 people taking Avandia in the UK, plus around 34,500 taking Avandamet.

What is the basis for these current reports? In July 2010 the Commission on Human Medicines (CHM) in Europe, an independent committee responsible for providing expert advice on drug safety, conducted a review into the safety of rosiglitazone after studies had demonstrated an increased risk of cardiovascular disease with the drug.

The Chair of the CHM subsequently informed the MHRA (the UK government agency responsible for ensuring that medicines and medical devices are safe and effective) that “the benefits of rosiglitazone are no longer considered to outweigh the risks”.

Importantly, the CHM’s review was not able identify any groups, including people without a raised risk of cardiovascular disease, for whom the benefits of rosiglitazone could outweigh the risks. The MHRA has issued advice to both healthcare professionals and patients who are currently using Avandia, Avandamet or Avaglim.

The EMA has recommended that all medications containing rosiglitazone should be completely withdrawn from the market in the next few months. The most recent press release from the FDA says that it will “significantly restrict access” to Avandia. The FDA has also restricted clinical trials involving the drug.

What does the MHRA advise doctors?The European review into the safety of rosiglitazone considered all available data, including several recent studies involving the drug. These studies were well-conducted and involved a large number of people with diabetes, and should therefore be seen as contributing to the growing body of global evidence.

The combined evidence suggests that rosiglitazone increases cardiovascular risk when compared with both inactive placebo and with pioglitazone, another anti-diabetes drug within the same class as rosiglitazone. Pioglitazone is marketed under the brand name Actos, or as Competact when combined with metformin.

In light of this review and the restrictions already placed on the use of rosiglitazone, (ie that it should not be used in people with heart failure or cardiovascular disease) the MHRA recommends that doctors should:

Put a system in place that ensures that all patients currently prescribed rosiglitazone are reviewed and changed to another suitable medication. Invite patients to visit in the near future rather than wait for the next routine appointment. It is hoped this will to reduce any patient anxiety. Diabetes is already a known risk factor for cardiovascular disease. If a person has suffered heart disease or a stroke while taking rosiglitazone, it is unfortunately not possible to say what role, if any, their medication could have played.

What does this mean for patients?The MHRA’s advice to patients is that:

Those who are prescribed Avandia, Avandamet or Avaglim should not stop taking their treatment. This is because the drugs will still be needed to manage blood sugar levels and there may be some risk in going unmedicated. Instead patients should contact the doctor or nurse supervising their diabetic treatment, who will issue appropriate guidance and an alternative drug for controlling blood sugar. Any fluid retention in the ankles or body that occurs as a result of rosiglitazone is likely to be reversed on stopping the medicine. However, as it is not known for certain by what mechanism rosiglitazone may increase the risk of heart disease, it cannot be said that the risk of heart disease decreases completely when people stop taking rosiglitazone. Patients should be routinely monitored for cardiovascular disease. However, if they have been experiencing shortness of breath, chest pains/tightness, fatigue, increase in weight, or swelling of ankles (or elsewhere), they should arrange to see their doctor or nurse as soon as possible. This guidance refers only to drugs containing rosiglitazone, ie Avandia, Avandamet and Avaglim. It does not apply to other diabetes medications. Patients can discuss any concerns they have about their treatment with the doctor or nurse looking after their diabetes

Up until now diabetes drugs containing rosiglitazone have been considered when diabetes cannot be controlled using either of the first-choice medications, metformin and sulphonylurea. The heart risk has been recognised for some time, with previous rulings by the MHRA saying that the drugs should not be used in people with heart failure or cardiovascular disease. However, continuing research into the safety of the drug has now led an advisory committee of the EMA to call for rosiglitazone to be withdrawn altogether. It echoes similar moves by the US Food and Drug Administration (FDA), which has recently placed tight restrictions on rosiglitazone drugs.

What is rosiglitazone, or Avandia?Rosiglitazone is a drug designed to help control type 2 diabetes by reducing the body’s resistance to insulin, ie allowing insulin to do its normal job of reducing blood glucose levels.

It is not a first-choice (first-line) diabetes medication, but until now it has been used to treat some patients who do not have adequate blood sugar control when taking the first-choice medications – metformin, a sulphonylurea drug or a drug combining both. In these cases rosiglitazone may be prescribed, either on its own or in combination with metformin or a sulphonylurea drug.

Rosiglitazone has also been prescribed for people already taking the combination of metformin and a sulphonylurea drug, but who need extra blood sugar control and cannot take insulin.

Rosiglitazone is supplied under the brand name Avandia, manufactured by GlaxoSmithKline. Rosiglitazone is also found in a drug called Avandamet, which combines rosiglitazone with metformin. Avandamet is subject to the same suspension as Avandia. Rosiglitazone is also found in the drug Avaglim, though this drug is not licensed for use in the UK.

Rosiglitazone was introduced in July 2000. There are currently an estimated 55,300 people taking Avandia in the UK, plus around 34,500 taking Avandamet.

What is the basis for these current reports? In July 2010 the Commission on Human Medicines (CHM) in Europe, an independent committee responsible for providing expert advice on drug safety, conducted a review into the safety of rosiglitazone after studies had demonstrated an increased risk of cardiovascular disease with the drug.

The Chair of the CHM subsequently informed the MHRA (the UK government agency responsible for ensuring that medicines and medical devices are safe and effective) that “the benefits of rosiglitazone are no longer considered to outweigh the risks”.

Importantly, the CHM’s review was not able identify any groups, including people without a raised risk of cardiovascular disease, for whom the benefits of rosiglitazone could outweigh the risks. The MHRA has issued advice to both healthcare professionals and patients who are currently using Avandia, Avandamet or Avaglim.

The EMA has recommended that all medications containing rosiglitazone should be completely withdrawn from the market in the next few months. The most recent press release from the FDA says that it will “significantly restrict access” to Avandia. The FDA has also restricted clinical trials involving the drug.

What does the MHRA advise doctors?The European review into the safety of rosiglitazone considered all available data, including several recent studies involving the drug. These studies were well-conducted and involved a large number of people with diabetes, and should therefore be seen as contributing to the growing body of global evidence.

The combined evidence suggests that rosiglitazone increases cardiovascular risk when compared with both inactive placebo and with pioglitazone, another anti-diabetes drug within the same class as rosiglitazone. Pioglitazone is marketed under the brand name Actos, or as Competact when combined with metformin.

In light of this review and the restrictions already placed on the use of rosiglitazone, (ie that it should not be used in people with heart failure or cardiovascular disease) the MHRA recommends that doctors should:

Put a system in place that ensures that all patients currently prescribed rosiglitazone are reviewed and changed to another suitable medication. Invite patients to visit in the near future rather than wait for the next routine appointment. It is hoped this will to reduce any patient anxiety. Diabetes is already a known risk factor for cardiovascular disease. If a person has suffered heart disease or a stroke while taking rosiglitazone, it is unfortunately not possible to say what role, if any, their medication could have played.

What does this mean for patients?The MHRA’s advice to patients is that:

Those who are prescribed Avandia, Avandamet or Avaglim should not stop taking their treatment. This is because the drugs will still be needed to manage blood sugar levels and there may be some risk in going unmedicated. Instead patients should contact the doctor or nurse supervising their diabetic treatment, who will issue appropriate guidance and an alternative drug for controlling blood sugar. Any fluid retention in the ankles or body that occurs as a result of rosiglitazone is likely to be reversed on stopping the medicine. However, as it is not known for certain by what mechanism rosiglitazone may increase the risk of heart disease, it cannot be said that the risk of heart disease decreases completely when people stop taking rosiglitazone. Patients should be routinely monitored for cardiovascular disease. However, if they have been experiencing shortness of breath, chest pains/tightness, fatigue, increase in weight, or swelling of ankles (or elsewhere), they should arrange to see their doctor or nurse as soon as possible. This guidance refers only to drugs containing rosiglitazone, ie Avandia, Avandamet and Avaglim. It does not apply to other diabetes medications. Patients can discuss any concerns they have about their treatment with the doctor or nurse looking after their diabetes

View the original article here

Doctors evaluation of heart problems should consider checking fat deposits around the heart

8-10/2010

Source: Cedars-Sinai Medical Center

In the journal of the American College of cardiology: cardiovascular Imaging, Cedars-Sinai Medical Center researchers say fat around the heart is more predictive than around the waist

LOS ANGELES (6 October 2010) heart imaging researchers in the Cedars-Sinai Heart Institute recommend that doctors are not fat deposits around the heart forget in the evaluation of patients at risk of major heart problems.

Although abdominal fat is often considered to be in making these assessments, recent research suggests that the measurement of adipose tissue around the heart an even better Predictor and noninvasive CT scan can offer this important information.

The recommendation appeared in an editorial published in the journal of the American College of cardiology: cardiovascular Imaging. Daniel s. Berman, MD, head of the cardiac imaging in the Cedars-Sinai Heart Institute and Cedars-Sinai s. Mark Taper Foundation Imaging Center, is the first author of the article and a leading authority in the heart imaging.

The published opinion was requested by another article in the magazine in which researchers demonstrate new abdominal fat must be linked to the instability of coronary arterial plaques.In the current theory, people with higher risk of excess abdominal fat accumulation of plaque and heart disease and plaque to rupture a greater threat than those which are stable.

With the co-authors Victor y. Cheng, M.D., and Damini Dey, Ph. d., Berman cites several studies that fat around the heart and the coronary arteries to inflammation and plaque development linking and suggests that fat around the heart and the coronary arteries "may be more potent determinants of coronary plaque development and progress than visceral abdominal fat."This fat around the heart is also involved in the development of important heart side effects (MACE), defined as heart-related death, fatal heart attack, surgery to get around Blocked heart arteries or repeated percutaneous coronary intervention (angioplasty) to reopen blocked arteries.

Under the leadership of Berman recently Cedars-Sinai the largest randomized trial of coronary artery calcium CT scan, after 2,137 subjects over four years.More than 20,000 patients are now entered in a register of the persistent data. this technology gives plaque deposits in the arteries by detecting of calcium, a powerful component of the plaque.In addition, using the methods of the software, can coronary artery calcium CT scan also be used to fat around the heart and the coronary arteries. The two measurements taken together plate and increased fat around the heart appear to improve the quality of life in the prediction of patients there is a risk of major heart problems.

In their study of the coronary artery calcium CT scan the researchers found Cedars-Sinai and other sites that patients are not affected by any signs of heart disease but had a significant adverse cardiac event experienced had more heart than fat around the issues that had no events. when they are a measure of FAT volume around the heart with conventional risk factors and coronary calcium scan, they were better able to predict what patients are more likely to great heart problems. in another study the researchers found that the amount of fat around the heart is strongly associated with the narrowing of the coronary arteries caused by plaque.

"Meet pericardial fluid fat from the heart CT primer seems to end up with a routine addition to the information that is gained from the evaluation of the plaque," the researchers conclude. "This assessment can generate CT information with regard to the business of atherosclerotic process (construction of plaque) add to meaningful clinical evaluation. "

The work was partially supported by grants from the Eisner Foundation, the Foundation Glazer, the Lincy Foundation, and the National Institute of Biomedical Imaging and bioengineering (National Institute of Health). Berman receives support research by Siemens Medical Systems.

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Vatican official against the Nobel Prize in IVF: conflict or debate?

By Bob McDonald, host of the CBC radio program scienceQuirks & quarks an official from the Vatican has stated that this year's award the Nobel Prize in Physiology or medicine to the British professor Robert Edwards for a world leader in in vitro fertilization or IVF treatment "completely out of line."  Is this another case of the Church in violation of the science, or an opportunity for an open discussion about how science should? Prof. Edwards introduced the world to the first test-tube baby, Louise Brown, who its 30th anniversary in 2008. Since then, IVF has provided a way for millions of infertile couples around the world have IVF children. However, is not a perfect process.  It takes many embryos for success is achieved, thus denying that many will be deleted. And that's where the Vatican has a problem. According to the teaching of the Church, all embryos be considered as human beings. Mgr. Ignacio Carrasco de Paula, head of the Pontifical Academy for life, said in a statement that prof. Edwards ' the wrong door "opened in research. According to the Vatican documents, IVF goes against their beliefs about the dignity of the Church argument determines on scientific behavior is different from the famous process of Galileo on his claim that the earth around the Sun.  In this case, the Church had the wrong facts.  In this case, the Church is not the argument against the accuracy of the science, it's a moral boundaries around scientific pursuits. It is against the storage and transport, the freezing of embryos for other purposes. This position reaches far beyond IVF in other areas of science, specifically the same stem cell research. Those embryos that have been removed by the fertility clinics by researchers to be seen as a source of stem cells.  They see great promise in stem cells for the treatment of many types of diseases for which there is no current treatment, such as Alzheimer's disease, Parkinson's disease, multiple sclerosis and heart disease. Stem cells can be converted into any type of cell in the body, so the idea is to make a healthy new nerve cells, blood cells, new body tissue, and maybe one day even new bodies. But embryonic stem cell research is embroiled in controversy, especially in the United States, where a fierce debate for religious, ethical, political and legal furious over the use of embryonic stem cells. This has financial and scientific effort to work on other sources of adult stem cells tissues.  Many researchers believe, however, that the use of adult stem cells greater technical challenges and much less features than the embryonic stem cells.  In Canada, because of the concern, the guidelines for embryonic stem cell research but have been constantly on the move slowly, and are very restrictive. In vitro fertilization of the Vatican against will probably not change the practice, because it's been so long and so many infertile couples children. But the broader issue of scientific research limited by religious concerns should be discussed as we are to continue. Where do we draw the line between science that has a huge potential, on the one hand, but part of the society on the other hand, an insult?

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Researchers at Childrens Hospital Los Angeles search Diet-induced obesity accelerates leukemia

The first study to show that obesity can accelerate the directly

progression of acute lymphoblastic leukemia (ALL) is carried out on

The Saban Research Institute for Childrens Hospital Los Angeles and was

Cancer Prevention Research, published on 5 October 2010. obesity

associated with an increased incidence of many types of cancer, including

leukemia, but it is unknown whether was the increase in the number of cases

a direct effect of obesity or in connection with genetic, lifestyle,

health, or socio-economic factors.

Appear in bold in red, structural cells are displayed in blue and leukaemia cells displayed in a yellow (photo: Business Wire)

"Given the high prevalence of obesity in our society, we felt it was

critical to determine if the increase in overweight causes

of leukaemia and no other associated exposure, "says Steven d.

Mittelman, MD, PhD, a paediatric endocrinologist who led the study.

Dr. Mittelman and his colleagues a high-fat diet used for the generation of obesity

in two mouse models for all. Mice were randomised to a high-fat or a

control diet. the researchers found that obesity increases the risk of

ALL in both models, especially in older mice. This comment was

According to the type of a cumulative effect with other

exposure related cancers, such as lung cancer with regard to smoking and

As a result of breast cancer increased estrogen exposure. compliance with the

difference in older animals also agreed with the other obesity

effects of cumulative exposure such as heart disease, diabetes, and

arthritis.

"Our results are consistent with the epidemiological data which show that a

higher incidence of leukemia in obese adults and proposes that this

comments are actually due to obesity, and some do not connected

genetic, socio-economic, or lifestyle factor, "Dr Mittelman, closed

who is also an Assistant Professor of Paediatrics and Physiology &

Biophysics at the Keck School of Medicine of the University of Southern

California. "This information mean that certain hormones or factor in obesity

individuals, maybe produced by fat tissue itself, the signal of leukemia

cells to grow and divide. leukemia is the most common type of

cancer, obesity can understand how increasing the frequency

could have significant public health consequences. "

Co-authors of the study included Jason P. Yun, James w. Behan, Nora

Hei, PhD, Anna Butturini, MD, Lars Groffen Klemm, John, PhD,

Lingyun-Ji and Markus Muschen, MD, PhD, of Childrens Hospital Los

Angeles.

The study was funded by the National Institute of the child

Health and human development, the National Cancer Institute, and the

Children's Cancer Research Fund (a non-profit organization for California).

The Saban Research Institute for Childrens Hospital Los Angeles is one of

the largest and most productive pediatric research facilities in the

100 researchers in 186 laboratory, United States of America

clinical trials as well as community-based research and The health services.

Saban Research Institute is eighth ranked in the National Institutes of

Health financing among children of hospitals in the United States.

Founded in 1901, Childrens Hospital Los Angeles is one of the nation

children's hospitals and is recognized worldwide for his

leading role in the health of children and adolescents. Childrens Hospital Los

Angeles is one of only seven children of hospitals in the country and

the only children's Hospital on the West Coast-sized for two

consecutive years in each of the 10 pediatric specialties in the u.s. news &

World report rankings and the name of the magazine "Honor Roll" of

children's hospitals.

Childrens Hospital Los Angeles is a premier academic hospital and has

connected to the Keck School of Medicine of the University of

Southern California since 1932.

Photos/multimedia gallery available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6461226&lang=en

Childrens Hospital Los Angeles

Ellin Kavanagh, 323-428-8336

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What is heart disease?

INSIGHT INTO THE BASE OF YOUR HEART AND THE HEART DISEASE

The principles that are linked to your heart and blood vessels to understand.Get a good understanding of the different types of cardiovascular diseases that can be confusing. get a basic overview of vascular diseases and conditions can affect your heart and blood vessels.

You probably hear a lot about the prevention of heart disease. but maybe you are not sure which heart disease. It's the same thing such as heart disease, coronary artery disease or other heart terms that sometimes do you see?

With many medical terms relating to the heart and blood vessels, it's no wonder that you may be surprised or confused.Here you have a chance of some basic concepts about cardiovascular disease (CVD), you can keep up to date. This can then help you when you watch the news or meeting with your doctor.

The first term to know is the heart disease or CVD. CVD is a broad term. CVD is a great collection of diseases and disorders.

If you want to be technical, CVD to any impairment in each of the different parts of your heart.Your cardiovascular system consists of your heart and blood vessels through your whole body.

Cardiovascular disease has two of the most important mechanisms:

Disorders of the heart (condition)

Diseases of the blood vessels (vascular)

Everything from an aneurysm of a heart attack on varicose veins are all types of CVD. you can be born with a kind of CVD (congenital), or you can get others later in life might of a lifetime of unhealthy habits, lack of exercise, smoking, and other factors.

Here is a closer look at the two mechanisms of cardiovascular diseases.

Disorders of the heart

The diseases and disorders that affect the heart is in a group known as the heart disease. the heart is a muscle that pumps blood. arteries supply blood to the heart muscle and the valves to ensure that the blood is pumped within the heart in the right direction. problems that can occur in one of these areas.

Just like the CVD is heart disease a broad concept.

Here are the types of heart disease:

** Coronary artery disease (CAD)

** Coronary heart disease (CHD)

** Cardiomyopathy

** Valvular heart disease

** Pericardial disease

** Congenital heart disease

** Heart failure (CHF)

Diseases of the blood vessels

Blood vessels are in basic terms, hollow that carry blood to the organs and tissues throughout your body tubes.

There are 4 types of blood vessels:

Arteries.

These blood vessels carry oxygen-rich blood to all parts of the body

Veins.

These blood vessels carry deoxygenated blood back to your heart. that is the reason why they have a bluish cast their color

Capillaries.

These are small vessels that connect to your arteries and veins.

Lymphatic.

Liquid manufactured from a base of the capillaries of leaks to bathe your cells.

Here are some types of blood vessel disorders:

** Arteriosclerosis and atherosclerosis

** High blood pressure (HBP) or Hypertension (HTN)

** Rate

** Aneurysm

** Peripheral arterial disease (PAD) and intermittens

** Vasculitis

** Venous incompetence

** Venous thrombosis or blood clot

** Varicose veins

** Lymphedema

Heart disease is a serious condition. watch your fat food intake, smoking, as well as your sweet tooth intake. both can lead to serious heart problems.

It is best to start slowly when changing your diet. eating fresh fruit and vegetables is a great way to get started.

F. Kuhn, RN
specialized in heart and diabetic education

http://www.heartnewscenter.com
http://www.diabetestestingcenter.com