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.
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.
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
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.
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
Not recommended if you...
Are younger than 18 years old
Benefits and harms not known in children younger than 18 years old
It is not known if Belviq passes into breast milk - women need to choose between Belviq and breastfeeding. They should not do both.
Have severe kidney disease (CLcr = <30 mL/min) or end stage kidney disease
Safe if pregnant or breastfeeding?
Do not take: Controlled human studies show Belviq harms baby and potential benefits do not outweigh potential harms (FDA Category X)
Unknown if Belviq gets into breast milk - either stop breastfeeding or stop Belviq
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