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Slimming drugs are back in the news in Brazil. Last Friday (23), the interim president, Rodrigo Maia, sanctioned a law that releases production, commercialization and consumption of the substances amfepramone, femproporex and mazindol, which inhibit appetite.
Known as anorectics, these drugs are derived from amphetamines and had been banned by Anvisa (National Health Surveillance Agency) in 2011. The agency’s argument for the veto was the lack of proof of the safety and effectiveness of these drugs.
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In a post made on social networks, Maia justified the approval. “I took the decision after listening to several medical entities and receiving a favorable opinion from the Federal Council of Medicine itself. I understand the drama of thousands of Brazilians who have dangerous levels of obesity and need to be taken seriously, and responsibly, having access to controlled medical treatment”, wrote, who is president of the Chamber of Deputies.
In a note, Anvisa positioned itself against the measure. “This law, in addition to being unconstitutional, may pose a serious risk to the health of the population. Legally, the Agency is responsible for regulating the sanitary registration of these substances, after rigorous technical analysis of their quality, safety and efficacy. This is what happens in developed countries and means a guarantee for the health of the population. Congress has not made, because it is not its role nor does it have the capacity to do so, any technical analysis of these requirements that are universally required to authorize the marketing of a medicine”.
What about sibutramine?
Sibutramine is one of the weight loss products that was not banned by Anvisa in 2011. And, with the new law, nothing changes: it continues as a therapeutic option in drugs that can be produced and sold in compounding pharmacies. According to the agency, there are currently 13 manufacturers registered with this drug in Brazil and 22 sibutramines on sale in the country.
Next, check out the opinion of experts on the use of weight loss remedies.
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Who should resort to drugs to lose weight?
Endocrinologist and nutrologist Durval Ribas Filho, president of the Brazilian Association of Nutrology (Abran), recommends the use of slimming substances for people with a BMI (body mass index) above 27, provided they have associated diseases (such as diabetes and hypertension ), or above 30 when there are no other complications. This is what the International Obesity Task Force recommends, a network of specialists that advise the World Health Organization (WHO) when it comes to obesity.
“Other than that, the ideal is to seek an adequate diet to re-educate eating habits, in addition to exercising”, he advises. The Brazilian Association for the Study of Obesity and Metabolic Syndrome (Abeso), in a guideline available on its website, indicates these drugs for cases of BMI above 25 when there are associated diseases (including high cholesterol) or above 30. “Obesity it is a chronic disease that needs treatment”, says endocrinologist Alexander Benchimol, vice-president of the entity.
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What are off-label weight loss medications?
They are those that work for another purpose than the one that is on the package insert. This is the case of liraglutide (sold under the trade name of Victoza), a medicine for diabetics that produces weight loss, and of topiramate, an anticonvulsant indicated for the prevention of migraines, which also has an effect against obesity.
“This practice is allowed by medical associations, but, as with any treatment, there may be side effects”, warns endocrinologist Marcio Mancini, from the Hospital das Clínicas of the Faculty of Medicine of USP, in São Paulo. “Off-label drugs should only be prescribed after clinical examinations and require strict follow-up.”
Is sibutramine a safe medication?
Conducted in 2009, the international study Scout, acronym for Sibutramine Cardiovascular Outcome Trial (cardiovascular effects of sibutramine, in a free translation) revealed a increased risk of heart attack for patients with cardiovascular diseases who received this substance for five years in a row. “For those who don’t have a heart condition, however, this drug has always been safe. It is not an anorectic, that is, it does not take away hunger. It is a satiety agent, that is, it acts on the central nervous system, increasing satiety. Thus, the person eats less. It also has mild thermogenic action, accelerating caloric expenditure“, explains Durval Ribas Filho.
However, there needs to be constant medical supervision and there may be side effects such as dry mouth, increased blood pressure, headache and nausea. The professionals interviewed for this report point out that, whatever the substance chosen to lose weight, it is important to associate its use with a change of eating habits and the practice of regular physical activities.
Is orlistat a good alternative?
Unlike sibutramine, which acts on the central nervous system, orlistat (the active ingredient in Xenical) has a local action, in the intestine, preventing the absorption of about 30% of ingested fat. It also decreases glucose production by the liver, with beneficial effects on carbohydrate metabolism. In some people, it causes diarrhea and flatulence. “It’s good to remember that those who suffer most from diarrhea are patients who continue to eat a lot of fat, hence the importance of combining the medicine with a dietary change”, says Alexander Benchimol.
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Should anyone who has already lost what they needed with medication continue taking it to maintain their new weight?
“It depends on each case”, says Marcio Mancini. “A woman who has always been thin, gained weight during pregnancy and used medication to get rid of those extra pounds will probably no longer need medication after treatment. A patient who has been obese for 20 years will possibly have to take it for the rest of his life”, compares the endocrinologist.
What’s better: the manipulated or the industrialized?
A few years ago, formulas that mixed permitted substances, such as sibutramine, with components harmful to health, such as thyroid hormones, or others that were only poorly indicated, such as diuretics, created a bad reputation for those that were manipulated. “But it may be a case of manipulation, depending on the patient’s profile”, says Durval Ribas Filho. The important thing is that the prescription is made by a trusted doctor.
Can you trust slimming drugs sold over the internet?
No. A obesity it is considered a disease and treatment must be prescribed by health professionals.
Do thermogenic supplements work?
For Durval Ribas Filho, they have a “discreet effectiveness” and, poorly administered, bring harm to health. “They are dangerous”, agrees Marcio Mancini. “They can speed up the heart and cause life-threatening arrhythmias.”
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