When it comes to losing weight, the best approach is to eat less and move more.
But for most, that’s easier said than done.
Although the potent combination of a calorie deficit diet and regular physical training has been tried and tested enough times for people to know that it is the only sustainable and healthy way to weight loss, some still look for quick fixes to speed up the process.
And that is why we have a bunch of aids to weight loss on the market. From transdermal patches to pills and injections, there is a wide variety of products that claim to help obese people lose weight without much effort.
While most over the counter weight loss schemes don’t make it through the scrutiny of healthcare authorities, a few have been successful in acquiring approval.
Mysimba is one such drug that’s been approved for use in patients who meet a specific obesity and health criterion.
The European equivalent to American Contrave, Mysimba is a combination medication that aids weight loss by altering the nervous system pathways responsible for hunger management in the body.
It received official authorization by the European Union in 2015, becoming legal in all of the 28 state members of the alliance.
Although there is still no compelling evidence that suggests unfailing efficacy of Mysimba, it still serves as a ray of hope for people who struggle to lose weight through the traditional means.
And that is why a vast majority of the obese population in the UK and also, worldwide, is using the drug.
However, most users don’t know much about Mysimba except for the fact that it’s a weight loss aid.
To help people better understand the various aspects of the said weight loss medication, here is an extensive review of Mysimba.
The Irish pharmaceutical company, Orexigen Therapeutics Ireland Limited, submitted an application to the Marketing Authorization to the European Medicines Agency to obtain permission to market Mysimba on October 2, 2013.
The manufacturers submitted a complete report and research analysis of the medicine to the European Agency, which included administrative information, complete quality data, non-clinical and clinical data based on applicants’ tests and studies and bibliographic literature substituting/supporting specific tests or investigations.
According to Orexigen’s application, Mysimba is a fixed-dose combination medicine formulated with 8 mg of Naltrexone and 90 mg of Bupropion per tablet that helps with obesity management in adults, when used in combination with necessary lifestyle and diet changes.
After a rigorous assessment process, the Committee for Medicinal Products for Human Use (CMPH), a subdivision of the European Medicines Agency issued authorization to Mysimba on December 18, 2014.
Although CMPH had some reservations regarding the medicine’s possible side effects, it still granted approval to Mysimba considering the potential benefits, which were significantly higher than the adverse reactions.
According to the European Medicines Agency, CMPH found that there are chances of users developing cardiovascular defects or experiencing seizures, but those are manageable and can be reversed by ceasing the use of Mysimba.
Apart from that, the Committee also found that even though the effectiveness of the medication in aiding weight loss is limited, it is still enough to issue an approval for Mysimba.
And that’s why the drug was given authorization.
Mysimba contains two active substances that work collaboratively to stimulate the weight loss process in obese people.
The said agents are:
Naltrexone hydrochloride is mentioned in the European Pharmacopoeia, which is the reference work for medicines manufactured and used in Europe.
The chemical name of Naltrexone is (5α)-17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride, corresponding to the molecular formula C20H24ClNO4 and has a relative molecular mass 377.85.
The second active agent used in Mysimba is Bupropion, which is also mentioned in the European Pharmacopoeia.
The chemical of the Bupropion is ((±)-2-(tert-butylamino)-3’-chloropropiophenone hydrochloride, corresponding to the molecular formula C13H18ClNO.HCl and a relative molecular mass of 276.21.
Both Naltrexone and Bupropion have been licensed individually for various uses by the European Union.
Other ingredients present in Mysimba include cysteine hydrochloride, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, lactose anhydrous, lactose monohydrate, crospovidone, dye fd&c blue #2 aluminium lake, hypromellose, edetate disodium, colloidal silicon dioxide, polyvinyl alcohol, titanium dioxide, macrogol and talc as described in section 6.1 of the SmPC.
Mysimba is a trilayer film-coated tablet consisting of two layers of each active substance and an inert layer separating the other two. The active layers in the product are prepared separately and then combined together.
Upon consumption, the middle layer in Mysimba disintegrates immediately separating the active layers, which allows the active agents to be released separately.
Research conducted on the efficacy of Mysimba suggested a positive correlation between weight loss and consumption of the drug when administered along with significant lifestyle changes.
Mainly four studies were carried out that included 4500 obese people, which were either given Mysimba or a placebo pill to assess the effectiveness of the former.
People who were given the active drug were also asked to eat healthily and exercise regularly.
The results of the studies indicated a higher percentage of weight reduction in people who took Mysimba for 28 to 56 weeks.
Out of all the participants of the study, 42% lost around 5% of their total body weight by the end of the trial.
Even though Mysimba doesn’t drastically trim someone down; however, it does facilitate weight loss to some degree.
And as a result, it reduces the risk of diseases such as type-2 diabetes and cardiovascular disease. It is also believed to help control blood sugar levels more effectively.
Just like any other drug, Mysimba can lead to a host of adverse side effects.
The most common reactions that a person can experience after consuming the drug are;
- Dry mouth
- Fatigue, sleepiness/drowsiness
- Pain in the abdomen
- Excessive sweating
- Feeling shaky
- Erratic heartbeat
- Increased blood pressure
- Hot flashes
- Ringing in ears
- Difficulty concentrating
Some Uncommon Side Effects of Mysimba
- Motion sickness
- Frequent burping
- Memory loss
- Loss of kidney function
- Abdominal discomfort
- Feeling hot
- Increased appetite, weight gain
- Sexual dysfunction
- Liver disorders
- Unbearable weakness
- Balance disorder
- Mood swings
Some Rare Side Effects of Mysimba
- Low white blood cell count
- Loss in red blood cell volume
- Swelling of lips, eyelids, tongue or throat
- Bloody stool
- Jaw pain
- Pain in the lower abdomen
- Coldness in extremities (hands and feet)
- Irregular menstrual cycles
- Dental problems
- Urgency to urinate
Although most side effects of Mysimba are manageable and not too dangerous, some can be debilitating. Those include;
- Depression, suicidal behaviour, urge to commit suicide and frequent suicidal thoughts.
- Seizures; the chances of someone having an episode of fits are rare, but they do exist. A person may experience convulsions and lose consciousness afterwards, chances of which are more if they take a dangerously high dose of Mysimba.
- Erythema multiforme and Stevens-Johnson Syndrome; both disorders affect the skin and lead to rashes, spots, itchiness, blisters and bleeding in different parts of the body.
- Rhabdomyolysis; a condition characterized by an abnormal breakdown of muscle tissues that can lead to kidney failure. Symptoms include muscle cramps, pain and weakness.
The manufacturers of Mysimba advise users not to take the drug if they;
- Have high blood pressure that is not controlled with medication
- Have a history of fits
- Have a condition that causes fits
- Have bipolar disorder
- Have an eating disorder
- Have kidney disease
- Have liver dysfunction
- Take medicines for depression or Parkinson’s disease called monoamine oxidase
- Are allergic to any ingredient in Mysimba
- Are dependent on opiates
- Are a recovering alcoholic
- Recently stopped or (plan to stop) taking medication for anxiety
- Have a brain tumour
- Are using any other drug containing the active ingredients of Mysimba; Naltrexone and Bupropion
Consulting a doctor before taking Mysimba is advisable for everyone. However, one should definitely talk to their doctor before taking the weight loss pill if they;
- Have depression
- Have suicidal thoughts
- Have a head injury
- Have a history of mania
- Have any sort of liver or kidney problems
- Have uncontrolled artery disease
- Have cardiovascular disease
- Are over 75 years of age
One should also inform their doctor if they are taking any of the following medicines;
- Medication to control blood sugar levels
- Antihistamines (a drug to treat allergies)
- Medicines to treat Parkinson’s, HIV, epilepsy, high blood pressure
- Quinolones (antibiotics)
- Tramadol (an opiate-based painkiller)
- Theophylline (a drug used to treat asthma)
Pregnant women or women trying to have a baby and lactating mothers are also advised not to take Mysimba. And if they wish to take it, then they must consult a doctor first.
The best practice to decide on a dose of Mysimba is asking your doctor and following their recommendation.
However, Mysimba’s package leaflet advises users to administer the medicine as follows
One tablet daily in the morning.
Two tablets daily; one in the morning and the other in the evening.
Three tablets daily; two in the morning and one in the evening.
Week Four and Onwards
Four tablets daily; two in the morning and two in the evening.
The recommended daily dose of Mysimba is four tablets taken in pairs twice a day.
Typically, a person is supposed to take the drug for 16 weeks and then consult their doctor if they wish to continue treatment.
The doctor will evaluate the impact of Mysimba and decide whether or not the patient should continue taking it.
What to do if you mess up your dosage routine?
In the case of missing a dose, make sure to take the next one on time.
If you take a higher than prescribed dose, consult your doctor immediately. An overdose of Mysimba can lead to adverse reactions quickly.
Who is it for?
Even though Mysimba is a medicine to treat obesity, not every overweight person can take it.
An obese person has to meet a particular health criterion in order to qualify as a potential user of the drug.
Only those overweight individuals can take Mysimba who have either of the following body mass index values.
- A BMI of 30 or more
- A BMI between 27 and 30, along with weight-related complications such as diabetes, cardiovascular disease, or high blood pressure.
People who take Mysimba also have to follow a calorie deficit diet and engage in moderate to high-intensity activities regularly to see results faster.
Without a healthy diet and frequent exercise, the efficacy of Mysimba isn’t much.
How does it Work?
In the simplest terms, the active components in Mysimba alter the functioning of the parts of the brain that control hunger management and energy balance.
Naltrexone and Bupropion reduce cravings and appetite, essentially bringing down the amount of food (calories) a person consumes.
When people don’t feel hungry often and do not get frequent food cravings, they are able to follow strict diets more consistently, which helps them lose weight faster.
Where to get it?
Mysimba is readily available at both online and brick-and-mortar pharmacies throughout the UK.
Although the marketing authorization holder of the weight loss drug is Orexigen Therapeutics Ireland Limited, Consilient Health Limited markets it in the UK.
Make sure only to buy the right medicines supplied by the relevant authority.
Does Mysimba Increase Metabolism?
Mysimba does increase energy consumption in the body to some degree. However, it doesn’t increase the user’s metabolic rate significantly.
With that said, when it is taken in combination with a restrictive diet and regular exercise, a person automatically burns more calories in a short amount of time.
How does Mysimba make you feel?
If the user isn’t affected by the possible side effects of Mysimba, then they are most likely to feel anything in particular.
However, if someone is predisposed to allergic reactions due to medicinal components, then they may feel the common side effects of Msyimba, which include, dry mouth, dizziness, nausea, vomiting, anxiety etc.
Aside from any adverse reactions, a Mysimba user feels satiated; hence they don’t eat much.
The Final Verdict
Obesity is a chronic condition that affects around 13 million adults in the UK.
Even though it is a highly prevalent health crisis, there are no shortcuts or quick fixes to treat it.
No matter how effective weight loss aids seem, they can only do so much. If you want to lose weight, you need to do most of the heavy lifting yourself (literally and figuratively!).
Mysimba, or any other weight loss aid, will only give your body a little nudge in the direction of weight loss by slightly curbing your appetite, but it cannot magically make you lean.
You need to put in the necessary effort of going on a restrictive diet and working out regularly if you want to see results.