Download Lorcaserin : The Serotonergic Weight Loss Medication

Lorcaserin : The Serotonergic Weight Loss Medication
Richard Lipman MD January 25, 2015
http://www.richardlipmanmd.com/weight-loss-medications/belviq
Belviq a Serotonergic Weight Loss Drug
The second new FDA approved weight loss medication is Belviq (chemical name Lorcaserin).
Unlike Qsymia, it is a totally new drug belonging to the serotonergic class of drugs. The term
“serotonergic” refers to medications whose mechanism of
action is to increase serotonin levels in the brain. Serotonin is a
chemical distributed all over the body. In the brain, it acts as a
neurotransmitter that sends messages between cells.
Serotonin is a Neurotransmitter
Serotonin is a chemical found all over the body. It is involved
in the brain centers involving sleep, sex, feelings of well being,
appetite, cravings, and much more. Everyone in the U.S. has
experienced high serotonin effects after a large turkey dinner.
One feels sleepy, happy, well-fed, and calm. All of these
feelings are due to the high serotonin levels produced by the turkey. Turkey is loaded with a
chemical called tryptophan, which is necessary for the production of serotonin. Eating turkey
and other foods high in tryptophan increases serotonin concentrations in our brain, which
produces calmness and fullness. Researchers from around the world over the past 30 years have
recognized the unique properties of serotonin to induce not only calmness but to reduce
depression, anxiety, and compulsive behavior. Only recently have they found drugs like Belviq
that reduces appetite and cravings by their direct effect on serotonin in the appetite centers of the
brain.
What does serotonin do in the brain?
It’s a messenger that transmits nerve impulses
from one nerve to another across small spaces
between nerves called synapses. After
serotonin has done its job normally, it is
pumped back into the nerve cell from which it
came. Most people are familiar with a group
of serotonergic drugs called SSRIs (selective
serotonin reuptake inhibitors). These drugs
work by keeping more serotonin in the brain
cells by blocking it’s re uptake by the cells
that first produced it. This ends up enhancing
the desired effect of the serotonin and thus the
medication. Prozac, a typical SSRI, acts by blocking the pump that sends serotonin back into the
cell. More serotonin is left in the synapse, ensuring better transmission of nerve impulses.
SSRIs are called selective because they seem to primarily affect serotonin and no other
neurotransmitters.
This ends up enhancing the desired effect of the medication. Prozac, a typical SSRI, acts by
blocking the pump that sends serotonin back into the cell. More serotonin is left in the synapse,
ensuring better transmission of nerve impulses.
Medications Effect Serotonin in Different Ways
Medications can act on the brain and effect serotonin levels in many ways. Whole classes of
drugs have been developed to treat depression, anxiety, and obsessive compulsive disorder based
on their interacting with specific serotonin receptors on the nerve endings in the brain. This
includes older anti-depressants, such as amitryptiline and nortryptiline and new ones in the
SSRI’s (Selective Serotonin Re-Uptake Inhibitors) group, such as Zoloft, Prozac, Paxil, and
Cymbalta. Belviq is different; it acts on different serotonin receptors to produce fullness, satiety,
and reduce cravings.
Lorcaserin Acts on Specific Serotonin Receptors Only in the Appetite Center of the Brain
The key to understanding the numerous actions of serotonin involves the serotonin receptors on
the nerve cell endings. The receptors are also called 5-hydroxytryptamine receptors or 5-HT
receptors. Fourteen different receptor subtypes, grouped into seven families, have now been
described. The basic family of 5-HT receptors is grouped by number and includes 5-HT1 thru 5HT7 families. Each of the families is divided into subgroups using letters to distinguish
subtypes. Thus, 5-HT1 receptors consist of 5HT1A, 5-HT1B, thru 5–HT1F. These receptors
control feelings of aggression, anxiety, appetite,
blood pressure, mood, sleep, sexual behavior, and
more. Activation of the 5-HT2B receptor on heart
valves was believed to be the cause of the heart
valve abnormalities seen with fenfluramine during
the phen/fen crisis. Medications like Belviq
activate the 5-HT2A and 5-HT2C receptors and are
not associated with cardiac valve problems.
Activation of these receptors is associated with
decreased appetite, diminished cravings, and satiety.
Belviq, or chemically name Lorcaserin, activates the 5-HT2C receptor and is termed a 5-HT2C
agonist. Agonist definition: An agonist is a chemical that binds to a specific receptor of a cell,
which then triggers a response by the cell.
Fenfluramine (the bad part of the phen/fen complex) was a potent stimulant of serotonin and
produced marked decrease in appetite and weight loss. It was not an SSRI like Prozac but
simply caused a massive release of serotonin from the nerve endings. As you will see, unlike
Belviq, it released serotonin into organs all over the body, including the heart valves. Although
not common, fenfluramine was found to damage the heart valves in the phen/fen scandals of the
late 1990s. More than five million dieters took phen/fen in the 1990s.
Belviq, on the other hand, only affects the serotonin receptors in the appetite center of the brain
which is located in the hypothalamus. Taking Belviq activates specific serotonin receptors in the
appetite center which sends a message of fullness, decrease hunger and satiety throughout the
appetite center and then throughout the brain.
Here is How Serotonin Works to Send Messages:
Neurons (nerve cells) exchange messages by using the part of a neuron called a synapse.
Synapses serve to connect nerve cells together. The neuron sends neurotransmitters across the
synapse to the second neuron. A receptor on the second neuron recognizes the neurotransmitters
and sends it message along its nerve to the next neuron. Below is a basic picture of the synapse
between two nerve cells where this exchange occurs. Here is a close-up of what is going on at
the synapse between neuron #1 and neuron #2 in someone taking Belviq for weight reduction.
Belviq is a selective
5-HT2C receptor agonist. 5-HT2C receptors are located almost exclusively in the brain and can
be found in the hypothalamus where appetite is controlled. The activation of 5-HT2C receptors in
the hypothalamus increases proopiomelanocortin (POMC) production and, consequently,
promotes weight loss through satiety. While it is generally believed that 5-HT2C receptors help
to regulate appetite, as well as mood and endocrine secretion, the exact mechanism of appetite
regulation is not yet known
Belviq Increases Fullness and Decreases Hunger and Cravings Without Any of the Typical
Weight Loss Medication Side Effects
Unlike the anti-depressant SSRIs, Belviq works by controlling appetite — specifically by
activating specific nerve cell receptors for serotonin in the appetite centers of the brain. In the
case of Belviq, the increased serotonin sends messages of increased feelings of fullness and
satisfaction. Researchers at Arena Pharmaceuticals who discovered and developed Belviq say
the drug selectively seeks out only serotonin receptors that affect appetite. Overweight
individuals lose weight by reducing their hunger and desire to eat. As a result, less food is
ingested, which means the body is taking in fewer calories, and the result is gradual and
progressive fat loss. Belviq does not produce side effects of anxiety, depression, insomnia,
palpations, racy heart, or constipation seen with the older appetite suppressors. In
addition, Belviq has no effect on metabolism or “fat burning” it simply reduces appetite
and food intake. In addition, Belviq is not associated with the development of tolerance
seen in other weight loss drugs.
Belviq is NOT Fenfluramine; It’s a Selective Serotonin Agonist, and its Safe
Belviq reduces hunger and cravings by altering specifically the 5-HT2C serotonin receptors
found on the brain cells in the hypothalamic appetite centers. It is what is termed a selective
serotonin 2C receptor agonist. It has no effect on the heart or heart valves or other organs of the
body. Since Belviq® is far more selective than fenfluramine, none of the destructive heart
issues have been noticed in clinical tests. This is exceptionally good news for its maker and the
general obese public who have waited 20 years for a safe, effective weight loss medication.
For a drug to be considered effective in fighting obesity, it must pass certain FDA guidelines as
to efficacy and safety. Arena Pharmaceuticals has researched Belviq® for nearly 10 years and is
convinced that it’s both effective and safe.
What Can You Can Expect to Experience Taking Belviq?
A 52-week trial of Belviq involving over 3,000 obese subjects found an average patient weight
loss of 12.7 lbs compared to the placebo group’s results of 4.7 lbs. Average weight losses are
difficult to interpret because of the wide ranges of starting weight in these studies. A more
productive way to evaluate the effectiveness of weight loss drugs is to study the percent of
subjects losing 5% and 10% of their initial body weight. This year long trial showed that 22% of
subjects taking Belviq lost 10% or greater bodyweight and 47.5% of Belviq treated patients lost
at least 5% of their weight. Belviq® has also been linked to drops in cholesterol levels and other
cardiovascular benefits. All in all, Belviq clearly meets the FDA requirements for a medication
to be considered an obesity fighting drug, which states that at least one-third of the trial patients
lose at least 5% of their bodyweight over the placebo or that at least two times the patients over
the placebo group must have experienced a 5% weight loss.
Minimal Side Effects Found with Belviq
Side effects reported in clinical testing of Belviq® are very mild and tolerable. The most
commonly reported side effect was headaches with approximately 16.8% of Belviq treated
subjects experiencing them. Nearly 10.1% of the placebo group experienced headaches. Using
the “placebo adjusted” value (This is obtained by subtracting the occurrence of a side effect in
the placebo group from the occurrence in the Belviq treated group), headaches occurred in 6.7%
of treated subjects. This was the only side effect that was above a 5% placebo difference. Other
side effects with less than 5% occurrence were dry mouth, fatigue, nausea, vomiting, and
dizziness. In most people, side effects tended to disappear after a few days. Supporting the
observations of only very mild side effects is the fact that only 7% of subjects withdrew from the
study because of adverse reactions. Another intriguing fact was that the discontinue rates for
testing were the same (7%) for actual Belviq® users and the placebo group. This is the lowest
placebo adjusted discontinue rate for an obesity drug ever. This is due to the fact the side effects
of Belviq were self-limited and so inconsequential. On the other hand, Qsymia studies had much
larger dropout rates due to the fact the side effects were much more common and disturbing to
some subjects.
What Can You Can Expect to Experience Taking Belviq?
A 52-week trial of Belviq involving over 3,000 obese subjects found an average patient weight
loss of 12.7 lbs compared to the placebo group’s results of 4.7 lbs. Average weight losses are
difficult to interpret because of the wide ranges of starting weight in these studies. A more
productive way to evaluate the effectiveness of weight loss drugs is to study the percent of
subjects losing 5% and 10% of their initial body weight. This year long trial showed that 22% of
subjects taking Belviq lost 10% or greater bodyweight and 47.5% of Belviq treated patients lost
at least 5% of their weight. Belviq® has also been linked to drops in cholesterol levels and other
cardiovascular benefits. All in all, Belviq clearly meets the FDA requirements for a medication
to be considered an obesity fighting drug, which states that at least one-third of the trial patients
lose at least 5% of their bodyweight over the placebo or that at least two times the patients over
the placebo group must have experienced a 5% weight loss.
Weight Loss Studies Using Belviq (Lorcaserin)
Initial Animal Studies of Belviq
The first study that showed blocking the 5-HT2c receptors in the hypothalamic appetite centers
in the brain could produce sustained weight loss was reported in 2008 from England.
Researchers showed that the 5-HT2c receptor on the nerve cells of the hypothalamus was critical
for regulation of eating in normal and obese mice.
This led to the development of Lorcaserin or Belviq, a pure 5-HT2c receptor agonist. Initial and
further studies found no increase risk of heart valve damage by this drug because it selectively
blocked only the 5-HT2c receptors in the hypothalamus and not the receptors on the heart or
other organs like fenfluramine. Phase 1”First in Humans” study was completed in 2004, which
outlined the pharmodynamics of the drug.
Early Therapeutic Studies with Belviq
The first therapeutic study in 2005 followed 469 obese women and men taking Belviq for 12
weeks. Interestingly, in this study, there was no attempt to change the food or exercise. The
testing involved three different doses-10mg, 15mg, and 20mg daily of Belviq. Patients taking
Belviq® lost on average of four lbs. with the 10 mg dose, 5.7 lbs. with the 15mg dose, and
almost eight lbs. taking the 20mg dose. Compared to the placebo group, the findings where
substantial, as the placebo group averaged a mere 0.7 lb. decrease. Thirty one percent of patients
lost more than 5% of their weight. Significant reduction in hip and waist circumference was
noted. There was improvement in metabolic abnormalities, including reduction in cholesterol
and fasting blood sugars.
BLOOM-BLOSSOM Studies of Belviq
In 2006, three sentinel studies of Belviq were begun called the BLOOM, BLOSSOM and
BLOOM-DM studies. These were conducted at 98 trial sites over the country from 2006 to
2009. The intent of the studies was to evaluate both the safety and efficacy of Lorcaserin for
weight loss and weight maintenance in conjunction with a lifestyle modification program. Study
participants were overweight or obese and some had hypertension, diabetes, and high cholesterol
at the start of the study. These groups were included so that the effect of Belviq on these
parameters could be evaluated.
They followed 3,182 obese subjects taking Belviq over two years, and the final results were
published in the prestigious New England Journal of Medicine in 2010. Forty seven percent of
participants lost 5% or more of their body weight. The average weight loss was 13 lbs. The
average weight loss in Belviq treated subjects was 8.2% compared to 2.1% in placebo treated
subjects. Similar to the 2005 studies, there was improvement in cholesterol, fasting blood sugar,
fasting insulin, and blood pressure as well as marked reductions in waist and hip circumferences.
Depression in Belviq Treated Subjects
Because other weight loss drugs have produced depression in the past, extensive efforts were
made to evaluate depression and anxiety during the studies. NO increase in depression was
noted in Belviq treated participants over the two-year period. As noted earlier, 5-HT2C agonist
groups of medications have been considered possible treatment options for depression. In the
2006 studies, no depression was found at baseline in the treated subjects, so no comment could
be made on the effect of Belviq on possible effect on depression co-existent depression.
Weight Loss at One Year with Belviq (Lorcaserin)
The upper graph below shows how many subjects lost 5% and 10% of their body weight after a
year’s treatment. Forty seven percent of subjects lost 5% or more and 23% lost at least 10% of
their starting weight. The proportion of subjects losing 5% or more of body weight was more
than twice that in the placebo group. The FDA considers a weight loss drug to be effective if it
results in 5% or greater weight loss from baseline after one year. The bottom graph shows the
weight loss in kg every four weeks over the year. Note most of the weight loss was achieved at
16 weeks with very little increase after that.
BMI and Waist Circumference Changes with Belviq
Belviq treated subjects had an average reduction in BMI of 2.6 over the year and a reduction in
average waist circumference of more than four inches.
Adverse Effects of Belviq
Upper respiratory infections, headache, dizziness, nasopharyngitis, and nausea were the most
common side effects of taking Lorcaserin. Here are the most common adverse effects:
Adverse effect
Belviq
Placebo
Headache
Dizziness
Fatigue
Nausea
Dry mouth
Constipation
16.8
8.5%
7.2%
8.3%
5.3%
5.8%
10.1%
3.8%
3.6%
5.3%
2.3%
3.9%
To correctly understand the occurrence of adverse effects it is necessary to subtract the incidence
of the adverse effect in subjects taking placebo from those taking Belviq. Corrected for placebo
effect, headache occurred in 7 %, upper respiratory infection in 3%, dizziness in 5%, and nausea
in 3% of patients. The rest of the side effects were even more minor and occurred in less than
3% of subjects, as compared to placebo treated subjects.
Belviq Has NO Cardiac Safety Issues
The BLOOM and BLOSSOM participants underwent rigorous cardiovascular safety assessments
using medical history, physical examination, ECGs, as well as repeated echocardiograms every
three months during the two-year study and for six months after completion of the study.
ECHOs were conducted at the time of screening, 24, 52, 76, and 104 weeks into the studies. The
cardiovascular safety of Lorcaserin over two years was obtained from more than 10,000
echocardiograms. The safety analysis revealed no evidence of cardiac valve disease during and
after the studies.
Belviq Produces Weight Loss and Improves Glucose Control in Diabetics: The BloomBlossom DM Studies
Excess body weight is the main contributor to the development of diabetes type 2. It’s estimated
that 85% of diabetics are either overweight (BMI greater than 27) or obese (BMI greater than
30). The first line of therapy for diabetics is diet and exercise. Weight loss of as little as 5% can
yield significant improvement in blood sugar control and go a long way in preventing vascular
complications and co-morbid conditions. Sadly, diabetics have severe difficulty losing weight
and controlling their blood sugars. Weight reduction in diabetics is far more difficult than in
non-diabetic overweight people. Current American Diabetic Association treatment guidelines
call for a moderate weight loss of 5-7% to improve glucose control and prevent vascular
complication.
The Bloom –DM study is the first to evaluate Belviq in patients with well-established diabetes
who are taking diabetic medications. The goal was to determine the medications' effect on
weight loss in this metabolically difficult group but also to see the Belviq’s effect of blood sugar
control.
This one-year study examined 604 subjects who were overweight and had diabetes mellitus.
They received 10 mg of Lorcaserin once or twice daily. Average starting weight was 236 lbs and
mean HbA1C was 8%. Thirty seven percent of subjects lost at least 5% of their body weight,
and 16% lost at least 10% of their initial body weight. Half of the subjects taking Belviq
achieved the recommended HBA1c level of less than 7%, almost twice seen in the placebo
group. The weight reduction was seen at two weeks and persisted throughout the study.
No Belviq related adverse side effects were observed in this study. Cardiac ECHO studies
showed no valvular damage. The authors of the study emphasized the significant improvement
in glycemic control with the drug. An interesting observation was the fact the improvement in
glucose control with Belviq and weight loss was very similar to that seen when anti-diabetic
agents are used alone for control of blood sugar. Note these subjects were already taking
Glycemic agents.
Conclusion on Belviq Clinical Studies
Belviq, used in conjunction with lifestyle changes, was associated with significant weight loss
and improved maintenance of weight loss. Belviq was also associated with significant
improvement metabolic abnormalities, such as blood pressure, fasting blood glucose, cholesterol,
and signs of inflammation. Diabetics who have traditionally great difficulty losing weight lost
weight and improved their blood sugar control with Belviq. Belviq may offer the obese diabetic
an effective treatment not only for weight loss but for blood glucose control. Belviq is the first
weight loss drug to provide this to diabetics.
Who Should Take Belviq for Weight Loss?
Indications for Taking Belviq for Weight Loss
Belviq is classified as a 5-HTC2 serotonin receptor agonist. That means it acts specifically on
the serotonin 5-HTC2 receptor, which is located in the nerve endings in appetite centers of the
brain. The medication acts to prevent the uptake of serotonin after it has been released at the
nerve endings. This action has the effect of increasing the concentration of serotonin in the
synapses between neurons. This effect sends a message that cascades through brain centers,
resulting in feelings of fullness, satiety, and some decrease in cravings. Specifically, it has no
effect on heart valves or an effect on anxiety, insomnia, emotions, or depression, as occurs often
with other weight loss medication. It is meant to be used with a reduced calorie diet and a
program of increased physical activity.
Since Belviq is a controlled, DEA class IV medication, you must see
your own physician for a prescription. At that time, you need to discuss
the following indications, adverse reactions, and contraindications with
him. You cannot purchase this drug OTC or without a prescription from
a physician who has conducted a personal physical examination in their
office.
Talking with You Doctor about Taking Belviq: Is it For You?
What Should You Know?
Belviq is indicated for any adult over 18 years of age with a BMI of 30
or greater(obese) or a BMI of 27 or greater (overweight) with at least one weight related comorbid condition, such as diabetes, high blood pressure, abnormal lipids, and heart disease.
Here is a current BMI table:
Contraindications for Belviq:
Pregnancy, Breast Feeding, Age: Belviq is contraindicated in pregnancy (pregnancy Category
X) and breast feeding individuals less than 18 years of age.
Priapism (painful erections) is a potential effect of 5-HT2c antagonists. Care should be used
prescribing Belviq to men who are predisposed to priapism, such as those with multiple
myeloma, leukemia, sickle cell anemia, and deformity of the penis. Slow Heart Rate, Heart
Block, and Congestive Heart Failure: Heart rate lowering was noted in 5.3% of Belviq treated
subjects. Belviq should not be used in people with bradycardia, heart blockage, congestive heart
failure, or valvular heart disease.
Serotonin Syndrome: Belviq is a serotonergic drug, and the possibility of developing Serotonin
Syndrome is possible; Serotonin syndrome consists of changes in mood, hallucinations, coma,
hyperthermia, tachycardia, and more.
Other Serotonin Drugs: Belviq has not been co-administered with other serotonergic or antidopaminergic agents, including antipsychotics. Thus, these drugs should be avoided when
taking Belviq.
Kidney or Liver: Belviq should be used in caution with subjects with moderate renal or liver
impairment.
Dosages and Administration:
The recommended dose of Belviq is 10 mg taken orally twice a day. Belviq can be taken with
and without food. Belviq is supplied as a blue, film-coated tablet with the “10.” Some people
take it when they first get up and when they are going to sleep. I believe it may be more
effective when taken immediately before breakfast and before dinner. This will produce a burst
in blood levels at dinner and throughout the evening. In addition, there is a psychological effect
of taking a medication that reduces eating right before a meal.
Tell your doctor and pharmacist what prescription medications, nonprescription medications, and
vitamins you are taking or plan to take.
Be sure to mention any of the following:
Medications That Might Effect Belviq:
You must discuss with your primary physician the possibilities you may be taking any of the
following medications. I have listed them by the indication for the use of these drugs. OTC
drugs must be looked at carefully because they often have multiple ingredients that may interfere
with Belviq.
Depression and cough medications: lithium, bupropion (Aplenzin, Forfivo, Wellbutrin,
Zyban), cabergoline, codeine (in some pain medications and cough medications),
dextromethorphan (in cough and cold medications)
Diabetic medications: flecainide (Tambocor), insulin and other medications for diabetes,
linezolid (Zyvox) - watch for low blood sugar.
Medications for erectile dysfunction: Viagra, Cialis, Levitra
Medications for migraine headaches: almotriptan (Axert), eletriptan (Relpax), frovatriptan
(Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), zolmitriptan (Zomig)
Medications for weight loss (both OTC and prescription): phentermine, diethylproprion,
phendimetrazine
Drugs involving serotonin, dopamine, norepinephrine - metabolism primarily affecting the
brain Mexiletine, monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan),
phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), tranylcypromine (Parnate),
odansetron (Zofran), propafenone (Rythmol), selective serotonin reuptake inhibitors (SSRIs)
such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax),
fluvoxamine, paroxetine (Paxil), and sertraline (Zoloft), selective serotonin/norepinephrine
reuptake inhibitors (SNRIs) such as duloxetine (Cymbalta) and venlafaxine (Effexor), tamoxifen
(Soltamox), timolol (Blocadren), tricyclic antidepressants (TCAs) such as amitriptyline,
amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine
(Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), trimipramine (Surmontil),
tramadol (Conzip, Ultram, Ryzolt)
Over the counter supplements: Tell your doctor what herbal products and nutritional
supplements you are taking, especially St. John's Wort, tryptophan, and herbs or supplements for
weight loss.
Avoid taking cough and cold or allergy medications when taking Belviq.
Your doctor may need to change the doses of your medications or monitor you carefully for
side effects. Many other medications may also interact with Belviq, so be sure to tell your
doctor about all the medications you are taking, even those that do not appear on this list.
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Tell your doctor if you have or have ever had blood cell problems, such as sickle cell
anemia (a disease of the red blood cells), multiple myeloma (cancer of the plasma cells),
leukemia (cancer of the white blood cells), a condition that affects the shape of the penis,
such as angulation, cavernosal fibrosis, Peyronie's disease, diabetes, heart failure, slow or
irregular heartbeat, other heart problems liver disease, or kidney disease.
Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If
you become pregnant, while taking Belviq call your doctor immediately. Belviq may
harm your unborn baby.
Tell your doctor if you are having surgery, including dental surgery; tell the doctor or
dentist you are taking Belviq.
You should know that Belviq may cause drowsiness, difficulty paying attention, or
remembering information. Do not drive a car or operate machinery until you know how
this medication affects you.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next
dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose
to make up for a missed one.
What side effects can this medication cause?
Belviq may cause side effects. Tell your doctor if any of these symptoms are severe or do
not go away:
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constipation
dry mouth
excessive tiredness
pain in the back or muscles
headache
dizziness
difficulty falling asleep or staying asleep
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anxiety
difficult, painful, or frequent urination
cough
toothache
blurred vision or other vision changes
dry eyes
Some side effects can be serious. If you experience any of these symptoms, call your doctor
immediately or seek emergency medical treatment:
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agitation
confusion
hallucinations (seeing things or hearing voices that are not there)
difficulty with coordination
muscle spasms, stiffness, or twitching
restlessness
fast, slow, or irregular heartbeat
sweating
fever
nausea
vomiting
diarrhea
difficulty breathing
swelling of the hands, arms, feet, or legs
difficulty paying attention or remembering information
depression
thinking about harming or killing yourself or planning or trying to do so
feeling high or unusually happy
feeling as though you are outside of your body
erection that lasts longer than four hours
discharge from the breast
breast enlargement in males
Belviq may cause other side effects. Call your doctor if you experience any.
What happens if I miss a dose? Take the missed dose as soon as you remember. Skip the
missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to
make up the missed dose.
What happens if I overdose? Seek emergency medical attention, or call the Poison Help Line at
1-800-222-1222.Overdose symptoms may include severe forms of some of the side effects listed
in this medication guide.
What should I avoid while taking Belviq This medication may impair your thinking or reactions.
Be careful if you drive or do anything that requires you to be alert. Do not take any other
prescription or over-the-counter weight loss products without your doctor's advice, especially
SSRI’s like anti-anxiety or anti-depressants.
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