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1 / FDA Consume r Hea l th In fo rma t ion / U .S . Food and D rug Admin i s t r a t ion JULY 2012

Consumer Health Informationwww.fda.gov/consumer

Medications Target Long-Term

Weight ControlM

ore than one-third of U.S. adults are obese,

and obesity contributes to a number of health

conditions, including high blood pressure,

type 2 diabetes, and high cholesterol.

To help obese and over weightAmericans who have been unsuccess-ul in getting their weight under con-

trol with diet and exercise, the Foodand Drug Administration (FDA) hasapproved two new medicationsthe rst drugs or long-term weightmanagement that FDA has approvedin 13 years.

Marketed as Belviq and Qsymia,these prescription medications wouldbe taken or the rest o a persons lie.For many people, obesity is a lie-long condition, but we dont alwaysthink o itor treat itas such,says Amy Egan, M.D., M.P.H., deputy

director or saety in FDAs Divisiono Metabolism and EndocrinologyProducts (DMEP).

Qsymia and Belviq are consid-ered lie-long therapies in patientswho respond to and tolerate them,says Egan.

The drugs are meant to be used inconjunction with a balanced diet andexercise, says Mary Roberts, M.D.,a medical ocer in DMEP. Thesedrugs are another tool to be used bysomeone trying to reach and stay at

a healthy weight, she says.

Are You a Candidate?You may be a candidate or taking Bel-viq or Qsymia i you are at least 18 and: your body mass index (BMI) is 30

or greater (obese); or your BMI is 27 or greater

(overweight) and you have atleast one other weight-relatedcondition.

Wom e n w h o a r epregnant or thinkingo becoming pregnant

should not take eithero these medications,Egan says , becauseweig ht loss o e rs nopotential beneit to apregnant woman andcan cause etal harm.Qsymia carries a riskor birth deects (cletl ip with or withoutclet palate) in inantsexposed during the rsttrimester o pregnancy.

How Do They Work?Belviqthe trade nameor the drug lorcase-rin is a 10 mg tablettaken twice a day thatwor ks by ac tivat ing apart o the brain thatcontrols hunger.

Belviq was tested in three clinicaltrials that lasted from 52 to 104 weeksand included nearly 8,000 obese andoverweight patients.

The average weight loss forpatients taking Belviq rangedfrom 3 to 3.7 percent over thosetaking a placebo.

In studies of patients withouttype 2 diabetes, about 47 per-cent o patients lost at least 5percent o their weight comparedwith 23 percent of pat ientstreated with placebo.

Belviq should be discontinued i apatient ails to lose 5 percent o theirweight after 12 weeks of treatment,as it is unlikely that continued treat-

ment will be successul.Qsymia is a combination o two

FDA-approved drugs: phentermine,an appetite suppressant, and topi-ramate, used to treat epilepsy andmigraines. Roberts explains thatQsymia is taken once a day, withpatients starting at the lowest dose(3.75 mg phentermine/23 mg topira-mate extended-release), then increas-ing to the recommended dose (7.5

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2 / FDA Consume r Hea l th In fo rma t ion / U .S . Food and D rug Admin i s t r a t ion JULY 2012

Consumer Health Informationwww.fda.gov/consumer

mg/46 mg). In some circumstances,patients may have their dose increasedto the highest dose (15 mg/92 mg).

Qsymia, was tested in two clinicaltrials which included nearly 3,700obese and overweight patients treatedor up to one year. The average weight loss of patients

taking Qsymia ranged rom6.7 percent (lowest dose) to 8.9

percent (recommended dose) overthose taking a placebo. Sixty-two percent of patients on

the lowest dose and 70 percenton the recommended dose lostat least 5 percent o their weightcompared with 20 percent treatedwith placebo.

If after 12 weeks, a patient has notlost 3 percent o his or her weight onthe recommended dose o Qsymia,FDA recommends that treatment be

discontinued or increased to the high-est dose. If after an additional 12weeks on the highest dose, a patientdoes not lose at least 5 percent oweight, Qsymia should be discontin-ued gradually.

The HistoryWhy has it been 13 years since the lastdiet drug was approved?

Eric Colman, M.D., deputy direc-tor o DMEP, says that drug com-panies have been testing potentialnew weight loss drugs, but none hadproven eective and sae or consum-ers until now.

Beore Belviq and Qsymia, the onlyprescription drug currently approvedor long-term treatment o obesitywas orlistat, marketed as Xenical.

Orlistat is also sold over the counterin a lower dose as Alli.But Colman explains that FDA has

a long history with weight-loss drugs,one set against a backdrop o chang-ing attitudes towards obesity. It wasntthat long ago, he says, that vanity wasconsidered the only reason to loseweight. That mindset has shited overthe last 20 years with recognition thatobesity is a serious health concern.

FDA approved the rst prescriptionobesity medication in 1947, an appe-

tite suppressant called desoxyephed-rine or methamphetamine. Over thenext ew decades, several more appe-tite suppressants were approved. In1973, FDA limited all weight lossdrugs to short term use, relect-ing concerns about an epidemic oamphetamine use, Colman says.

In 1997, two diet drugs wereremoved rom the market because

o concerns about damage to heartvalves. They were enfuramine (parto the popular en-phen) and dexen-uramine (Redux). In 2010, the drugsibutramine (Meridia) was alsoremoved because o concerns aboutan increased risk o heart attacks andstrokes.

The manuacturers o both Belviqand Qsymia will be required to per-

orm long-term trials to examine theeect o these products on the risk orheart attacks and strokes.

Find this and other Consumer

Updates at www.fda.gov/

ForConsumers/ConsumerUpdates

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Qsymia and Belviq are considered life-long therapies

in patients who respond to and tolerate them.

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