Tag: Food And Drug Administration

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Weight Loss Exercise

Belviq Weight Loss Pill to Treat Obesity



The U.S. Food and Drug Administration today approved Belviq weight loss pill (lorcaserin hydrochloride), as an addition to a reduced-calorie diet and exercise, for chronic weight management.

Who Can Use the Belviq weight loss pill?

The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obese), or adults with a BMI of 27 or greater (overweight) and who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).

BMI, which measures body fat based on an individual’s weight and height, is used to define the obesity and overweight categories. According to the Centers for Disease Control and Prevention, more than one-third of adults in the United States are obese.

“Obesity threatens the overall well being of patients and is a major public health concern,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition.”

How Does Belviq Work?

Belviq Weight Loss Pill to Treat Obesity

Belviq Weight Loss Pill to Treat Obesity

Belviq weight loss pill works by activating the serotonin receptors in the brain. Activation of this receptor may help a person eat less and feel full after eating smaller amounts of food.

According to clinical trial data submitted by Arena to the FDA, nearly half of dieters without Type 2 diabetes who used the medication lost at least 5% of their starting weight — or an average of 12 lbs. — over a year, compared with 23% of those taking a placebo. For best results, dieters are advised to use the medication together with a healthy diet and exercise program.

However, the Belviq weight loss pill won’t immediately be available for sale. The drug has to go through a four-to-six month process at the Drug Enforcement Administration for a scheduling classification used for drugs that have a likelihood or potential of being abused

Who Should Avoid the Belviq weight loss pill?

Belviq should not be used during pregnancy. Treatment with Belviq may cause serious side effects, including serotonin syndrome, particularly when taken with certain medicines that increase serotonin levels or activate serotonin receptors. These include, but are not limited to, drugs commonly used to treat depression and migraine. Belviq may also cause disturbances in attention or memory.

In 1997, the weight-loss drugs fenfluramine and dexfenfluramine were withdrawn from the market after evidence emerged that they caused heart valve damage. This effect is assumed to be related to activation of the serotonin 2B receptor on heart tissue. When used at the approved dose of 10 milligrams twice a day, Belviq does not appear to activate the same serotonin receptor.

How about Qnexa?

Another weight loss pill called Qnexa is expected to be approved in the next month by the FDA and would be direct competition to the Belviq weight loss pill.

According to researcher Michael Davidson from the University of Chicago, patients who took Qnexa experienced significant reductions in weight.

“In this study, Qnexa patients on the top dose had sustained weight loss greater than 10 percent over two years,” Davidson said. “This weight loss led to clinically relevant reductions in blood pressure, triglyceride reduction greater than 25 percent and a dramatic increase in HDL levels.”

He added that achieving and maintaining this degree of weight loss is often difficult for patients, and that these promising results show that the drug could be a good way to improve heart health and cholesterol levels.

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Weight Loss Exercise

Sunscreen and Babys




Sunscreen and babys has been and issue since my daughter was born 12 years ago. No one really cares about sunscreen and babys until they have their own.  You’re at the beach, slathered in sunscreen. Your 5-month-old baby is there, too. Should you put sunscreen on her? Not usually, according to Hari Cheryl Sachs, M.D., a pediatrician at the Food and Drug Administration (FDA).

“The best approach is to keep infants under 6 months out of the sun,” Sachs says, “and to avoid exposure to the sun in the hours between 10 a.m. and 2 p.m., when ultraviolet (UV) rays are most intense.”

Sunscreen and Babys

Sunscreens are recommended for children and adults. What makes babies so different?

For one thing, babies’ skin is much thinner than that of adults, and it absorbs the active, chemical ingredients in sunscreen more easily, explains Sachs. For another, infants have a high surface-area to body-weight ratio compared to older children and adults. Both these factors mean that an infant’s exposure to the chemicals in sunscreens is much greater, increasing the risk of allergic reaction or inflammation.

The best protection is to keep your baby in the shade, if possible, Sachs says. If there’s no natural shade, create your own with an umbrella or the canopy of the stroller.

If there’s no way to keep an infant out of the sun, you can apply a small amount of sunscreen—with a sun protection factor (SPF) of at least 15—to small areas such as the cheeks and back of the hands. Sachs suggests testing your baby’s sensitivity to sunscreen by first trying a small amount on the inner wrist.

Cover Up your baby

Sunscreen and Babys

sunscreen and babies

The American Academy of Pediatrics (AAP) suggests dressing babyes in lightweight long pants, long-sleeved shirts, and brimmed hats that shade the neck to prevent sunburn. Tight weaves are better than loose. Keep in mind that while baseball caps are cute, they don’t shade the neck and ears, sensitive areas for a baby.

Summer’s heat presents other challenges for babies.

Younger babys also don’t sweat like we do, Sachs says. Sweat naturally cools the rest of us down when we’re hot, but babies haven’t yet fully developed that built-in heating-and-cooling system. So you want to make sure your baby doesn’t get overheated.

In the heat, babies are also at greater risk of becoming dehydrated. To make sure they’re adequately hydrated, offer them their usual feeding of breast milk or formula, says Sachs. The water content in both will help keep them well hydrated. A small of amount water in between these feedings is also okay.

Sun Safety Tips for Babys

Here are some things to keep in mind this summer when outside with babies:

  • Keep your baby in the shade as much as possible. If you do use a small amount of sunscreen on your baby, don’t assume the child is well protected.
  • Make sure your child wears clothing that covers and protects sensitive skin. Use common sense; if you hold the fabric against your hand and it’s so sheer that you can see through it, it probably doesn’t offer enough protection.
  • Make sure your baby wears a hat that provides sufficient shade at all times.
  • Watch your baby carefully to make sure he or she doesn’t show warning signs of sunburn or dehydration. These include fussiness, redness and excessive crying.
  • Hydrate! Give your baby formula, breast milk, or a small amount of water between feedings if you’re out in the sun for more than a few minutes. Don’t forget to use a cooler to store the liquids.
  • Take note of how much your baby is urinating. If it’s less than usual, it may be a sign of dehydration, and that more fluids are needed until the flow is back to normal.
  • Avoid sunscreens containing the insect repellant DEET on infants, particularly on their hands. Young children may lick their hands or put them in their mouths. According to AAP, DEET should not be used on infants less than 2 months old.
  • If you do notice your baby is becoming sunburned, get out of the sun right away and apply cold compresses to the affected areas.

The FDA has a lot of other info that is great for health in the Summer and in the sun, not just about sunscreen and babys. Check it out at http://www.fda.gov

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Weight Loss Exercise

Abdominal Belt: Are They Effective for Weight Loss?




Abdominal fat is a problem for many people, prompting them to find ways and means to get rid of belly fat fast. Unfortunately, fat in the abdominal area is often difficult to lose. Even with exercise and diet, belly fat sometimes refuses to go away. In their quest for a trim physique, some people wear abdominal belts in the hope that it will help to flatten their tummy.

Abdominal belts for weight loss are advertised on TV infomercials and the internet with promises that these devices hold the secret to rock-hard abs without the need for sit ups, crunches, or a low-calorie diet. Let’s find out more about the abdominal belt and see if it is effective for weight loss.

What Is an Abdominal Belt?

An abdominal belt is a special electronic device that you can wear around your waist at all times of the day. Manufacturers of abdominal belts claim that this device will help develop your abdominal muscles without the need for exercise. The belt electrically stimulates the abdominal muscles while you sit or relax. You can also exercise while wearing the belt to enhance the development of your abdominal muscles.

How Does an Abdominal Belt Work?

Abdominal weight loss belts are equipped with small pads that the user attaches to the bare skin. The pads contain electrodes that send a series of electrical pulses to different areas on your stomach. The pulses stimulate the muscles, allowing them to contract and relax. This simulates the effects of exercise.


Abdominal Belt: Are They Effective for Weight Loss?

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Requires FDA Clearance

Abdominal belts that use electrical muscle stimulation are classified as medical devices, according to the FDA or Food and Drug Administration. The sale of abdominal belts to consumers must be pre-approved. Currently, only the Slendertone Flex abdominal EMS belt has FDA clearance for toning the abdominal muscles.

Results of Research Studies

A small study conducted at the University of Wisconsin measured the effects of abdominal EMS belts on test subjects. The test subjects wore the belts for 20 to 40 minutes every day, five days a week. At the end of the study, the test subjects reported losing an average of 1.38 inches around their waist. Abdominal strength increased by an average of 58%. The control group reported no significant changes in these measurements. Neither group experienced significant weight loss.

The study was funded by a former distributor of Slendertone Flex belts.

Are Abdominal Belts Effective?

Abdominal belt manufacturers claim that aerobic exercise can benefit belt wearers. The stretching and constant movement during aerobic exercise along with electric impulses from the belt is said to stimulate the abdominal muscles more intensely. The Federal Trade Commission, however, says abdominal belts have questionable value to consumers. The FDA also warns that these devices have caused minor and serious injuries including pain, irritation, bruises and burns. There are no magic pills or devices for losing weight. The only proven combination is a good diet and exercise.

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