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Cancer, bowel drugs on FDA safety scrutiny list

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Cancer, bowel drugs on FDA safety scrutiny list

More than a dozen drugs including a cancer therapy and a bowel medicine are under early scrutiny for potential side effects, U.S. regulators said in a quarterly list released on Thursday.

The Food and Drug Administration said it was investigating cases of liver failure in patients treated with Pfizer Inc’s cancer drug Sutent. The agency also is reviewing gastrointestinal perforation reported with Relistor, a drug from Wyeth and Progenics Pharmaceuticals for treating opioid-induced constipation.

Appearing on the list “means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk,” the agency said.

The FDA releases a quarterly list of safety probes as part of an effort to inform the public about early investigations of potential side effects that have been reported. The list released on Thursday covers issues identified between January and March 2009.

Pfizer said in a statement it would “work with the FDA to assess the reports (on Sutent) and determine a path forward.”

In clinical trials, liver failure was seen in less than 1 percent of patients with solid tumors who were treated with Sutent, the company said.

“We stand behind the safety and efficacy of Sutent,” Pfizer said. The drug is approved for treating advanced kidney cancer and a digestive cancer known as gastrointestinal stromal tumor.

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Inhalers may raise risk of asthma in some children

in.reuters.com

Inhalers may raise risk of asthma in some children

Common asthma reliever drugs taken by millions of children around the world may increase the risk of asthma attacks in some patients with a particular genetic make-up, British scientists said on Tuesday.

The researchers found that salbutamol, a popular blue inhaler medicine also known as Ventolin, as well as salmeterol, an ingredient in GlaxoSmithKline’s Advair, are less effective in children with a specific gene variant and may in some cases make their asthma worse.

The scientists said their findings suggest that carrying out genetic tests on children before treatment could be a more cost-effective way of treating them.

“This is a global question that needs to be addressed,” said Somnath Mukhopadhyay of Brighton and Sussex Medical School.

Salbutamol is called albuterol in the United States and is very widely used, the researchers told a news conference.

U.S. drug regulators have cautioned in the past that asthma drugs like Advair and Serevent, also made by Glaxo, may actually increase asthma risk in some patients. Glaxo said in a statement it had carried out its own studies with Advair and Serevent and found no genetic variation response differences, although the 500 patients in its study were older than 12.

“Albuterol is one of the commonest drugs right across the world. It is used in the United States, in Africa, India…” said Mukhopadhyay. “It’s cheap, it’s popular, and it’s good stuff — when it works.”

Asthma affects more than 300 million people worldwide and is the most common children’s chronic illness. Symptoms include wheezing, shortness of breath, coughing and chest tightness.

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Oats (Super Foods!)

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Oats (Super Foods!)

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The common oat (Avena sativa) is a species of cereal grain grown for its seed, which is known by the same name (usually in the plural, unlike other grains). While oats are suitable for human consumption as oatmeal and rolled oats, one of the most common uses is as livestock feed. Oats make up a large part of the diet of horses and are regularly fed to cattle as well. Oats are also used in some brands of dog and chicken feed.

Uses

Oats have numerous uses in food; most commonly, they are rolled or crushed into oatmeal, or ground into fine oat flour. Oatmeal is chiefly eaten as porridge, but may also be used in a variety of baked goods, such as oatcakes, oatmeal cookies, and oat bread. Oats are also an ingredient in many cold cereals, in particular muesli and granola. Oats may also be consumed raw, and cookies with raw oats are becoming popular.

Oats are also occasionally used in several different drinks. In Britain, it is used for brewing beer. Oatmeal stout is one variety brewed using a percentage of oats for the wort. The more rarely used Oat Malt is produced by the Thomas Fawcett & Sons Maltings and was used in the Maclay Oat Malt Stout before Maclay ceased independent brewing operations. A cold, sweet drink made of ground oats and milk is a popular refreshment throughout Latin America. Oatmeal caudle, made of ale and oatmeal with spices was a traditional British drink and a favorite of Oliver Cromwell.

In Scotland a dish called Sowans was made by soaking the husks from oats for a week so that the fine, floury part of the meal remained as sediment to be strained off, boiled and eaten (Gauldie 1981). Oats are also widely used there as a thickener in soups, as barley or rice might be used in other countries.

Oats are also commonly used as feed for horses – as plain whole or rolled oats or as part of a blended food pellet. Cattle are also fed oats, either whole, or ground into a coarse flour using a roller mill, burr mill, or hammer mill.

Soluble fiber

Oat bran is the outer casing of the oat. Its consumption is believed to lower LDL (“bad”) cholesterol, and possibly to reduce the risk of heart disease.

Oats contain more soluble fiber than any other grain, resulting in slower digestion and an extended sensation of fullness. One type of soluble fibre, beta-glucans, has proven to help lower cholesterol.

After reports of research finding that dietary oats can help lower cholesterol, an “oat bran craze” swept the U.S. in the late 1980s, peaking in 1989, when potato chips with added oat bran were marketed. The food fad was short-lived and faded by the early 1990s. The popularity of oatmeal and other oat products again increased after the January 1998 decision by the Food and Drug Administration (FDA) when it issued its final rule allowing a health claim to be made on the labels of foods containing soluble fiber from whole oats (oat bran, oat flour and rolled oats), noting that 3.00 grams of soluble fiber daily from these foods, in conjunction with a diet low in saturated fat, cholesterol, and fat may reduce the risk of heart disease. In order to qualify for the health claim, the whole oat-containing food must provide at least 0.75 grams of soluble fiber per serving. The soluble fiber in whole oats comprises a class of polysaccharidesBeta-D-glucan. known as

Beta-D-glucans, usually referred to as beta-glucans, comprise a class of non-digestible polysaccharides widely found in nature in sources such as grains, barley, yeast, bacteria, algae and mushrooms. In oats, barley and other cereal grains, they are located primarily in the endosperm cell wall.barley, yeast, bacteria, algae and mushrooms. In oats, barley and other cereal grains, they are located primarily in the endosperm cell wall.

Health

Oats are generally considered “healthy”, or a health food, being touted commercially as nutritious. The discovery of the healthy cholesterol-lowering properties has led to wider appreciation of oats as human food.

Protein

Oat is the only cereal containing a globulin or legume-like protein, avenalin, as the major (80%) storage protein. Globulins are characterized by water solubility; because of this property, oats may be turned into milk but not into bread. The more typical cereal proteins such as gluten and zein are prolamines (prolamins). The minor protein of oat is a prolamine; avenin.

Oat protein is nearly equivalent in quality to soy protein, which has been shown by the World Health Organization to be equal to meat, milk, and egg protein The protein content of the hull-less oat kernel (groat) ranges from 12–24%, the highest among cereals.

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