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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

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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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FLEXability

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Why?
Stretching your muscles is good preparation for all types of sports and fitness; it helps prevent injury for people who exercise intensely, or, on the flipside, for people whose muscles are stiff. By fitting out the stretching area in your club with equipment featuring cutting-edge technology, you’ll open new horizons for your business, relaunching an activity that has the potential for a very broad user spectrum.

The FLEXability™ Line is Anterior and Posterior, two pieces of equipment that together stretch all the body’s main muscle groups, designed to achieve maximum performance for minimum effort in every exercise.

Users can adjust FLEXability™ entirely on their own; it’s designed for total comfort, revolutionizing the stretching experience and transforming it into a pleasant new form of exercise.

Who’s it for?
Athletes who want to prevent strains and other injury and reduce the muscle tension caused by intense, targeted workouts.

For mature exercisers, who want to maintain and, where possible, improve the elasticity and flexibility of their joints and the efficiency of their muscles.

For people who want to relax with a pleasant exercise that’s non-invasive but still produces results for your physical condition.

For newcomers to physical activity, in order to increase their ability to move and help get themselves into a more active lifestyle: the more movement they’re able to do, the easier it will be to tackle all the other options available in your club.

Stretching your muscles doesn’t require specific training, and that’s even more true with FLEXability™: thanks to its Method (dynamic, innovative, and patented), the line makes it possible to gradually adjust the stretching range based on your weight, preventing any risk under any condition and for any user.

And for people who want that extra incentive?
FLEXability™ is designed for that too: thanks to an assessment and feedback system on reachable results, the equipment measures the progress of your flexibility, motivating all types of users to improve their mobility and muscle extension day after day.

Choose flexibility: with FLEXability™, traditional stretching takes on a new face, becoming a high-performance activity that’s engaging for every user segment.