Search Weight Loss Topics:




Jun 28

FDA approves 1st new weight loss drug in 10 years

Long Term Weight Loss Comments Off on FDA approves 1st new weight loss drug in 10 years

(CBS News) The obesity pill Belviq (lorcaserin) has been approved by the U.S. Food and Drug Administration to be used in conjunction with diet and exercise as a weight management treatment option. It's the first new long-term weight loss drug to hit the U.S. market in over a decade.

The FDA announced Wednesday that the drug is approved for adults with a body mass index (BMI) of 30 or over - which indicates obesity - or with a BMI of 27 or greater (overweight) who have at least one weight-related health problem such as high blood pressure, Type 2 diabetes or high cholesterol. It is manufactured by Switzerland-based Arena Pharmaceuticals.

Panel advises FDA to approve lorcaserin obesity pill FDA panel backs obesity pill Qnexa: What happens next?

"Obesity threatens the overall well being of patients and is a major public health concern," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a written statement. "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."

There are currently two prescription drugs used to treat obesity including the appetite-suppressant phentermine, and orlistat (Xenical), which prevents dietary fat from being absorbed by the intestine. Orlistat is sold over-the-counter as Alli in a lower dose.

The FDA cited three studies of nearly 8,000 overweight and obese patients - with or without Type 2 diabetes - who were treated from 52 weeks to 104 weeks with the drug or a placebo, along with exercise and diet counseling. The studies found about 47 percent of patients without Type 2 diabetes lost at least 5 percent of their body weight compared with about 23 percent of patients treated with placebo. In people with Type 2 diabetes, about 38 percent of patients treated with Belviq lost at least 5 percent of their body weight, compared to 16 percent in patients treated with placebo.

The drug's label will recommend that people stop taking the pill if they don't lose 5 percent of their body weight after 12 weeks of treatment, as those patients are unlikely to achieve meaningful weight loss even with continuing treatment. The drug should also not be taken by pregnant women.

Side effects from Belviq include serotonin syndrome - a potentially life-threatening drug reaction that causes the body to produce too much serotonin and causes symptoms of agitation, diarrhea, heavy sweating, fever, muscle spasms, tremors or mental health changes. People taking antidepressants or migraine drugs that increase serotonin levels may be at an increased risk for this side effect. The drug may also cause "disturbances in attention or memory," the FDA said.

Belviq should be used with caution in people who have congestive heart failure, according to the FDA, but studies found no significant difference in heart valve problems between people taking Belviq and those taking a placebo. Studies of some earlier weight loss pills reported heart valve damage as a potential side effect.

See the rest here:
FDA approves 1st new weight loss drug in 10 years

Related Posts

    Your Full Name

    Your Email

    Your Phone Number

    Select your age (30+ only)

    Select Your US State

    Program Choice

    Confirm over 30 years old

    Yes

    Confirm that you resident in USA

    Yes

    This is a Serious Inquiry

    Yes

    Message:



    matomo tracker