Belviq

Lorcaserin

For Weight Loss

Track record

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Medium (approved in 2012)

Bottom line

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Weight Loss

What is Weight Loss?

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While a few extra pounds may not seem like a big deal, they can increase your chances of having high blood pressure and high blood sugar. These conditions may lead to serious health problems, including heart disease, stroke, type 2 diabetes, and certain cancers.

Other treatments for Weight Loss

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Non-drug

Over-the-counter

Prescription

TABLE OF CONTENTS

Overview

Bottom Line

Limited benefit

In his summary review of the drug Belviq, the Director of FDA's Office of Drug Evaluation said, “The efficacy of lorcaserin (Belviq) is not impressive but also is not out of line with other weight loss drugs…a small proportion of patients may achieve impressive and probably quite important weight loss. Unfortunately, this will not be the experience of the majority of users”. The nearly identical weight loss findings for the FDA-approval studies make the benefit numbers more believable. But the only long-term (2-year) study showed that people on the drug gained weight back after the first year. No study has shown that Belviq prevents heart problems or strokes, a major reason to treat obesity.

Concern about serious harm

The FDA is requiring the company to conduct a large trial to learn the drug's effect on heart attacks, strokes and heart valve problems. The European Medicines Agency said approval was unlikely in Europe because it thought benefits did not outweigh harms, including possible cancers, psychiatric disorders, and heart valve problems.

FDA-approved use

For weight loss for adults - Belviq should be used in combination with a reduced calorie diet and increased exercise

FDA recommends you stop Belviq if you have not lost 5% or more of your body weight after 12 weeks on the drug

Who might consider taking it?

Adults who are overweight or obese

Adults who are overweight (Body Mass Index (BMI) of 27 to 29.9) with a weight-related problem (high blood pressure, high cholesterol, or heart disease) or are obese (BMI of 30 or higher)

What is not known

Not tested with other prescription, over-the-counter, or herbal weight loss products

It is not known if Belviq changes your chance of heart problems or stroke or of death due to heart problems or stroke

Track record

MEDIUM TRACK RECORD

Medium track record means that new‚ unexpected side effects are possible. Belviq was approved by FDA in 2012. As with all new drugs‚ rare but serious side effects may emerge after Belviq is on the market when larger numbers of people - with other conditions and on other medications - have used the drug.

Open questions

Ongoing studies FDA required to answer questions about harms

The FDA is requiring the company to conduct a large trial to learn the drug's effect on heart attacks, strokes and heart valve problems. The European Medicines Agency said approval was unlikely because it thought benefits did not outweigh harms, including possible cancers, psychiatric disorders, and heart valve problems.

Do not take if you...

Are pregnant or planning to become pregnant

Belviq may harm your unborn baby

Safe if pregnant or breastfeeding?

Pregnant

Do not take: Controlled human studies show Belviq harms baby and potential benefits do not outweigh potential harms (FDA Category X)

Breastfeeding

Unknown if Belviq gets into breast milk - either stop breastfeeding or stop Belviq

NEXT: TRIALS

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