Qsymia

Phentermine/topiramate

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

FDA-approved use

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

FDA recommends you evaluate weight loss after 12 weeks of treatment. If you have not lost at least 3% of your body weight on Qsymia 7.5mg/46mg, stop Qsymia or increase dose. If you have not lost at least 5% of your body weight after 12 weeks on Qsymia 15mg/92mg, stop Qsymia because it is unlikely to work.

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

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

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

Track record

MEDIUM TRACK RECORD

Medium track record means that new‚ unexpected side effects are possible. Qsymia was approved by FDA in 2012 based on studies where about 2,300 people took approved doses of the drug for 12 months. As with all new drugs, rare but serious side effects may emerge after the drug 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

FDA is requiring the company to conduct studies to answer open questions about possible increased chance of heart attacks and strokes or kidney damage from the drug

Do not take if you...

Are pregnant or planning to become pregnant

Have glaucoma

Have an overactive thyroid

Take monoamine oxidase inhibitors (MAOIs) for depression or have taken them in the past 2 weeks

Are allergic to Qsymia or its ingredients

Including topiramate and phentermine (or other sympathomimetic amines)

Safe if pregnant or breastfeeding?

Pregnant

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

Breastfeeding

Do not breastfeed while taking Qsymia - either stop breastfeeding or stop Qsymia

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