Drugs like Ozempic and Wegovy show no link with suicide, FDA says

No, of course not.

Just as antidepressents were deemed to "definitely not" increase the risk of suicide, violence and homicide in all ages (but the FDA admitted in 2007 they can), and a certain Covid treatment was deemed to "definitely not" cause heart inflammation (but the FDA admitted in 2023 they can), another batch of highly profitable drugs have also been declared "safe."

All of these treatments just mentioned, and especially drugs for obesity, are not only worrisome for the severe side-effects they can cause, but also because they never allow the user to really fundamentally change the underlying problems in their life until they stop taking them.

Just wait, there is no easy way to lose weight. This product will be banned for weight loss in a few years.

As we often do, when it comes to adverse reactions of medications, we turn to the US FAERS reporting system. Where we find, for CY 2023, that of all adverse reactions reported for just the two named labels, Ozempic and Wegovy: 83 were for suicidal ideation (1.21%), 100 for depression (1.46%), 38 depressed mood (.55%), 11 mood swings (.16%), 10 suicidal depression (.15%), 9 unspecified psychiatric disorder (.13%), 7 depressive symptoms (.10%), 6 completed suicide (.09%), 6 hallucination (.09%), and 5 intentional self injury (.07%).

Enough for the FDA to consider issuing a Black box warning, advising of potential serious safety risk. Most likely not.

Enough for the American Association of Clinical Endocrinology to make a specific clinical practice guideline warniing? Probably not.

Enough for practitioners to consider incorporating into their prescribing advice - within informed consent - describing the potential as statistically very small yet worthy of mention? And as something for a patient to immediately report if experienced? Or for a practitioner to carefully consider a patient's psychiatric diagnostic history before prescribing? Best practice? Yes.

No, of course not

That argument can only apply if you can demonstrate any of the evidence offered is faulty, else it is just a personal antiscientific bias and trying to push this belief into others without a valid basis. No reference, no proof of any of the claims you make, the article on the other hand clearly mentions an specific investigation done to address the concerns that did not show a link.

So what part of the information of the report is not valid or false, based on what evidence?

*All of these treatments just mentioned, and especially drugs for obesity, are not only worrisome for the severe side-effects they can cause, but also because they never allow the user to really fundamentally change the underlying problems in their life until they stop taking them.*

That is the opposite of how the drugs act, they do not magically reduce the weight but instead only allow the patient to change their lifestyle more easily, their whole point is to fundamentally change the underlying problem.

Just wait, there is no easy way to lose weight. 

Since the patients still have to do the difficult part (changing their diet and doing exercise) to lose the weight this criticism is not valid. The drugs have been available and used by the public already for more thant "a few years" without being banned. There is no realistic possibility they cause specific problems (when used under proper medical vigilance) for a new use if it was not present for their previous one.

As we often do, when it comes to adverse reactions of medications, we turn to the US FAERS reporting system.

But that is only half of the information necessary to understand the risk. The other half is the reports of the same problem for a demographics adjusted population that is under treatment for the same problems but without semaglutides. Having 83 cases of suicidal ideation is good enough to pay attention and keep vigilance, but if an equivalent group treated with other drugs had 120 cases it becomes clear the cause is not likely to be the drugs specifically. It is not enough to show incidence, it is still necessary to show an increase of the incidence related specifically to the drug.

But that is only half of the information necessary to understand the risk. The other half is the reports of the same problem for a demographics adjusted population that is under treatment for the same problems but without semaglutides . . . It is not enough to show incidence

Yes. So we await further research. Not only over the practitioner's FAERS reports, but also the statistical relevance, particularly in regards to other drugs and other substances taken by those patients, but also some indicia of pre-existing conditions and relational severity of symptoms relating to dosage and other factors. And the guidance that should / must follow.

But, yes, you are also correct in pointing out the need for a prescriber's early and continuous vigilance. And the duty that all who prescribe must undertake when initial attention (this piece follows an FDA "preliminary review of side effects") is drawn to an identifed risk - even if small - that presents potential substantial harm. Adequate informed consent is made for such moments.

The medications help control blood sugar levels and reduce the risk of heart disease in people with type 2 diabetes.

But they also come with a number of serious serious side effects. And they cause a considerable loss of lean body mass, which is not desirable. A natural approach is much healthier, effective, and cheaper.

In a study looking at 2029 people consuming a carnivore diet, they found that diabetics who did a carnivore diet for at least 6 months: 100% came off injectable medications, 92% came off insulin completely, 84% came off all oral medications.

https://pubmed.ncbi.nlm.nih.gov/34934897/#full-view-affiliation-2

the FDA is run by "former" pharmaceutical bosses. thus, all drugs produced by their employers are perfectly safe. trust them !

But they also come with a number of serious serious side effects

Which compared with the much more serious and frequent problems they prevent still make them the better option.

And they cause a considerable loss of lean body mass, which is not desirable.

That is produced also by hypocaloric diet without using any drug, which obviously mean the drugs are not the ones causing it, they just make it easier to follow the diet.

A natural approach is much healthier, effective, and cheaper.

And for many patients hugely much more likely to fail, resulting in worse outcomes for them, which is a perfectly valid justification for using the drugs as recommended.

In a study looking at 2029 people consuming a carnivore diet, they found that diabetics who did a carnivore diet for at least 6 months: 100% came off injectable medications, 92% came off insulin completely, 84% came off all oral medications.

But in any longer scale any and all diets result in the same outcome, patients abandon the lifestyle changes and rebound even to higher weights (not to count the specific risks coming from diets not recommended by the medical consensus). What semaglutides do is not only making easier for patients to succeed in following a better diet (thus achieving the benefits) but also keep at it without rebounding.

the FDA is run by "former" pharmaceutical bosses. thus, all drugs produced by their employers are perfectly safe. trust them !

Without actual evidence that contradict the findings this is irrelevant. The information from the federally funded study is available, do you have any argument that contradict the conclusions taken from the data presented? if not that remains valid and a justification to say special risks have not been identified.

That argument can only apply if you can demonstrate any of the evidence offered is faulty, else it is just a personal antiscientific bias

The evidence is easily accessible and freely available to anyone reading anything other than a mission/vision statement from a particular large pharmaceutical company.

https://www.npr.org/sections/health-shots/2023/09/21/1200201186/as-ozempic-use-grows-so-do-reports-of-possible-mental-health-side-effects

https://www.drugwatch.com/ssri/suicide/

https://pubmed.ncbi.nlm.nih.gov/38193825/

How many more times will you ask for evidence, with which you are provided, before ultimately dismissing for some arbitrary reason?

That is the opposite of how the drugs act, they do not magically reduce the weight but instead only allow the patient to change their lifestyle more easily, their whole point is to fundamentally change the underly

Interesting, where have we heard this before?

Take a drug for obesity, but make sure it's done in conjunction with a healthy exercise and nutrition plan.

Take antidepressants, but ensure you're also making serious endeavors to get to the root cause of your problem.

Roll-up your sleeve for a certain vaccine, but for best results do so while maintaining an active lifestyle and supplementing with Vitamin D, Vitamin B3, quercetin and zinc.

It doesn't take a genius to figure out something is Not Quite Right with this picture.

The evidence is easily accessible and freely available to anyone reading anything other than a mission/vision statement from a particular large pharmaceutical company.

Yes, and that is what originated the scientific investigation that is being reported here, no significant elevation of the incidence on people under treatment. When you have to pretend the article you are commenting does not exist to have a point you are also accepting the article clearly contradicts your point.

How many more times will you ask for evidence, with which you are provided, before ultimately dismissing for some arbitrary reason?

That the information do NOT prove the claim you are making is not an "arbitrary reason" is a perfectly valid argument that disprove your claim. The problems being treated have negative mental health repercussions, so it is obvious people being treat will have a base level of incidence. there is nothing surprising in finding this is the case, what is necessary is to present evidence people being treated with semiglutides have higher incidence rates compared with other treatments.

There is no evidence of that, even after scientists and experts have searched for it, so until that evidence is present the claim that is available is still false.

Interesting, where have we heard this before?

In the explanation of the action of countless drugs that are being used without problems today for a large variety of health problems? that is the whole point of a lot of medical interventions, not solve a problem magically but letting the physiology deal with the problem in a much more effective and easier way?

Pretending something bad must be happening just because you have a personal bias against anything scientific or medical is what is "not quite right" and obvious for anybody that can think rationally.

So many dangerous side effects with these drugs, according to the experts.

Diet and exercise are the safest way to go.

So many dangerous side effects with these drugs, according to the experts.

Diet and exercise are the safest way to go.

The whole point is that the drugs allow for diet and exercise to be adopted successfully and reduce the important risks to the health to be avoided. The whole point of these drugs are approved is that the limited risks of their use are much less important than the much more significant risks they help to avoid.

Do you have any source that said the FDA failed when it approved those drugs "according to the experts"?

The whole point is that the drugs allow for diet and exercise to be adopted successfully and reduce the important risks to the health to be avoided. The whole point of these drugs are approved is that the limited risks of their use are much less important than the much more significant risks they help to avoid.

Diet and exercise to maintain weight without using these drugs is the safer way to go according to the experts. As has been reported right here, those drugs gave several risks.

https://japantoday.com/category/features/health/popular-weight-loss-drugs-linked-to-higher-risk-of-stomach-paralysis

Diet and exercise to maintain weight without using these drugs is the safer way to go according to the experts.

Yet you failed again to provide any source (much less an expert's) supporting this claim, all drugs have negative side effects, that does not mean not using them automatically is better.

So, what expert said the FDA failed when it approved the drugs to be used as a way to lower the risk from failure to adopt a better lifestyle? without that reference you are only repeating your personal claim and trying to force it by pretending the experts support it, they don't.

Yet you failed again to provide any source (much less an expert's) supporting this claim, all drugs have negative side effects, that does not mean not using them automatically is better.

So you accept the drugs have side effects that are dangerous. Very good.

Oh, and here's you the other day promoting healthy lifestyles, in case you forgot:

What makes you think the WHO do not promote healthy lifestyles?

https://www.who.int/initiatives/behealthy/healthy-diet

So you accept the drugs have side effects that are dangerous. Very good.

Every drug have them, the problem with your claim is that this do not make not using drugs the better option, easily proved because you have not been able to bring any expert saying that it is better not to use these drugs even for patients where this means less risks.

Oh, and here's you the other day promoting healthy lifestyles, in case you forgot:

That can include using pharmacological help, that is the point you are supposed to refute but have not been able.

So, again, Do you have any source that said the FDA failed when it approved those drugs "according to the experts"?

Obesity is generally caused by a poor diet, over eating and lack of exercise. If I was obese I’d rather take action myself, have discipline and get into better health, not take a drug that might make me want to kill myself.

Pills and vaccines are not to answer to all ailments and diseases. What about preventative medicine, a worldwide campaign to encourage exercise and healthy eating? It will never happen, the usual culprits cannot profit from this and people taking less meds.

But they also come with a number of serious serious side effects

Which compared with the much more serious and frequent problems they prevent still make them the better option.

At most, they might be effective at reducing weight. But I have yet to see any evidence showing they improve health.

And they cause a considerable loss of lean body mass, which is not desirable.

That is produced also by hypocaloric diet without using any drug, which obviously mean the drugs are not the ones causing it, they just make it easier to follow the diet.

Yeah, if one chooses to do an extended fast or follow an severely hypocaloric diet, lean mass will also be lost. But there is no need to do that.

A natural approach is much healthier, effective, and cheaper.

And for many patients hugely much more likely to fail, resulting in worse outcomes for them, which is a perfectly valid justification for using the drugs as recommended.

No, there is no reason why it would fail. The main problem is that most people (including many doctors) have been so indoctrinated to avoid meat and fat.

There is no valid reason why anyone would need any of these drugs.

I understand that most of the body’s serotonin is made in the gut, so any change in gut biochemistry may affect that.