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Both American and European drug authorities are now investigating Novo Nordisk’s popular slimming medicine for new, previously unknown side effects.
It is the slimming drugs Ozempic and Wegovy that are now suspected of causing side effects such as hair loss, suicidal thoughts and aspiration. This emerges from a recent report from the American FDA (Food and Drug Administration).
The FDA will now investigate the suspicion of these new, previously unknown possible side effects in more detail.
In Norway, there have been 17 reports of suicidal thoughts as a suspected side effect after use of Saxenda, Ozempic and Wegovy.
This is shown by new figures DMP (Directorate for Medical Products, formerly the Norwegian Medicines Agency) has extracted for Dagbladet.
The company behind the medicines, Novo Nordisk, tells Dagbladet that they are still confident about the medicines’ benefit/risk profile.
See response from the manufacturer further down in the matter.
Usage exploded
Last year, the new slimming medicine Wegovy became available on the Norwegian market. And usage has exploded.
Figures obtained by FHI for Dagbladet show that 73,454 Norwegians took out at least one prescription with the active ingredient semaglutide last year.
Lose weight with new medicine
Ozempic is a medicine against type 2 diabetes, but is also used as a slimming medicine. Wegovy is an anti-obesity medicine. The active substance in both medicines is semaglutide. It is this active ingredient that is suspected of leading to suicidal thoughts.
But why can diet pills lead to suicidal thoughts? Sigurd Hortemo, senior physician at DMP, explains that the active substance semaglutide leads to weight loss by affecting the center in the brain that controls appetite and satiety.
– It is therefore not entirely unlikely that semaglutide can also affect the desire for things other than food, and affect emotions, he says.
He adds:
– So far no authorities have concluded that there is a connection.
“Potential security risk”
In a report from September, it emerged that the FDA had then registered 201 cases of suicide or suicidal thoughts among patients using medicine with semaglutide. In addition, there have been at least 422 cases of hair loss.
The FDA is now considering the need for “regulatory action”. The medicines are listed with a “potential safety problem”. The FDA emphasizes that this does not mean that a causal relationship has been established between the active ingredient and the listed side effects.
The report is discussed by, among others CNN and Danish BT.
The European Medicines Agency (EMA) is already investigating side effects of these medicines, after last summer there were several reports of side effects involving self-harm and suicidal thoughts.
– There have been reports that some of those who have used Ozempic and Wegovy have had thoughts of harming themselves and had suicidal thoughts. Such messages have been received both in Norway and other countries, says Hortemo in DMP.
The slimming agent rimonabant (Acomplia) was withdrawn from the market in 2014 because it led to suicidal thoughts. However, the active ingredient in this medicine was different.
AFFECTS THE BRAIN: Sigurd Hortemo, senior physician at DMP, explains that the slimming medicine works on the satiety center in the brain. Photo: Stian Lysberg Solum / NTB Show more
Hair loss
He explains that this is why the EMA now has an ongoing process to clarify whether there is a connection between the suspected side effects and the slimming drugs. EMA’s conclusion is expected during the spring.
Hortemo believes it is useful for the US FDA to also carry out its own assessment, as they have now announced that they are in the process of doing.
– It is interesting that the FDA will also look at hair loss as a possible side effect. As far as I am aware, no process relating to this has been initiated here in Europe, says the superior.
The pharmaceutical company Novo Nordisk, which is behind both medicines, is headquartered in Denmark.
– Patient safety has the highest priority at Novo Nordisk and we take all reports of side effects from the use of our medicines very seriously. EMA continuously monitors safety information, and so does Novo Nordisk. Novo Nordisk is still confident in the benefit/risk profile for these medicines, says Tor Frostelid, press contact in the Norwegian department.
Video originally published on dagbladet.no/dbtv.no on 06.01.2014 SHOCKED: Super slimmer Bob Jones kept his weight loss hidden from his parents. After a weight loss of 60 kilos, he came home for Christmas and surprised his parents. Check the reaction! view more
Study acquits
A study recently published in the journal Nature concluded that the drugs Wegovy and Ozempic did not increase the risk of self-harm and suicidal thoughts. The study looked at the records of more than 240,000 patients. Here they have compared the use of medicine with the active substance semaglutide with the use of other slimming medicines and found that medicines with samaglutide led to a lower risk of suicide in patients with overweight and obesity.
– Safety data obtained from large clinical study programs and data obtained after the drug has been marketed have not shown any causal relationship between either semaglutide or liraglutide and suicide or thoughts of self-harm, says Frostelid at Novo Nordisk.
Regarding the new suspected side effect aspiration, the explanation is as follows:
Semaglutide and the other so-called GLP-1 analogues can affect the emptying of the stomach so that it empties more slowly.
Cases have been reported where patients using GLP-1 analogues have had stomach contents in the lungs (aspiration) during operations under general anaesthesia. This is a dangerous and, at worst, life-threatening condition.
The FDA will now assess whether the use of GLP-1 analogues has meant that the stomach of these patients has not been empty, even if they have fasted in the usual way before the operation.
2024-01-11 05:27:46
#warnings #diet #pills