Ozempic, the “magic” drug to lose weight, is in the crosshairs of the EU

by time news

2023-08-07 20:28:00

A weight loss drug called Ozempic was popularized on TikTok and is considered “magic” by many Hollywood stars to lose weight. But the drug is being targeted by the European Union (EU) and UK and US medical authorities after dozens of reports of self-harm and suicidal thoughts among large numbers of people who used it.

Ozempicoriginally developed as an injectable antidiabetic drug, uses a molecule called semaglutide it mimics a hormone that can slow down stomach emptying. The drug acts like a hormone in the brainwhich makes people feel less hungry and slows the removal of food from the stomach, which stimulates weight loss.

According to Jean-François Thébaut, vice president of the French Federation of Diabetics, semaglutide is “extremely effective in balancing diabetes“and a medicine that”for the first time reduces cardiovascular-related complicationswith that ailment.

The name of the drug is Wegovy y was approved to treat obesity in several countries, including the United States in June 2021, but popularized by many Hollywood figures, such as the Kardashian sisters and Rosie O’Donnelland became fashionable all over the world to lose weight.

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“When I look around this room, I can’t help but wonder, ‘Is Ozempic right for me?'”said US presenter Jimmy Kimmel when he joked at the 2023 Oscars about the blockbuster drug that is “all the rage” in Hollywood.

Elon Musk, one of the richest men in the worldHe said Ozempic left him “fit, lean and healthy” and said he lost nearly 30 pounds after taking the drug. In October 2022, when asked by a follower what the secret to his new look was, he replied “fasting and Wegovy”. But he also admitted to having a side effect of the drug: he admitted that it makes him burp with “tasted like rotten eggs“.

Until today, in Argentina, Ozempic is only authorized for patients with type 2 diabetes. and there are specifications for its use: it must be prescribed together with a low-calorie eating plan and an increase in physical exercise to maintain control of body weight.

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In many countries, the “magic drug” is indicated for people who have an initial body mass index greater than 30 (obese), or between 27 and 30 (overweight). in the presence of at least one weight-related comorbiditysuch as diabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease.

According to the European Medicines Agency, “the active substance in Ozempic, semaglutide, is a GLP-Q receptor agonist. It works in the same way as GLP-1 (a hormone produced in the intestine). increasing the amount of insulin released by the pancreas in response to food“.

“In this way, it helps to control blood glucose levels,” they said. They added: “Studies have shown that Ozempic is effective in lowering blood glucose levels and reducing the risk of health complications in patients with type 2 diabetes.”

In between its side effectsthere are digestive problems such as diarrhoea, vomiting and nausea, although of mild or moderate intensity and of short duration that affect only 1 in 10 patients.

Recently, health experts raised concerns after Ozempic became a phenomenon on social media as a “miracle” treatment for rapid weight loss, which generated warnings about misuse.

Disturbing reports of depression, self-harm and suicidal thoughts

In mid-July, the EU medicines watchdog said it was reviewing Ozempic and two other popular weight-loss drugs after reports that they can trigger suicidal thoughts and self-harm among users.

The safety committee of the European Medicines Agency said that “is reviewing data on the risk of suicidal thoughts and thoughts of self-harm with medication… including Ozempic (semaglutide), Saxenda (liraglutide), and Wegovy (semaglutide),” it was reported on July 11.

The European agency received 150 reports of such people taking drugs of this classcalled GLP-1 receptor agonists, which lower blood sugar and suppress appetite by mimicking a hormone in the gut.

Then last week, the UK Medicines and Healthcare Products Regulatory Agency told the agency Reuters what I was reviewing drug safety data after similar reports.

The safety committee of the European Medicines Agency is reviewing reports of Ozempic users who had suicidal thoughts and self-harm.

Neither Ozempic nor Wegovy, which are versions of a drug called semaglutide in different doses, have been reported to have warnings about suicidal ideation in Europe or the UK, because clinical trials showed no evidence of increased risk.

However, the US Food and Drug Administration, which approved Wegovy, requires that weight-control drugs that work on the central nervous system carry a warning about suicidal thoughts.

Due to FDA approval as a weight loss treatment, the Wegovy prescription label advises medical professionals to monitor for these symptoms and to stop the drug if people develop them.

But Ozempic, which is only FDA-approved to treat diabetes, It doesn’t come with that warning..

Until March of this year, The FDA said it received 75 reports of depression, suicidal ideation or suicide attempts. related to Ozempic and 5 related to Wegovy.

But an agency representative said the FDA “cannot verify that the reported events are directly caused by the drugs.” “There is no evidence of increased risk of suicidal ideation, behaviors or death by suicide in any of the clinical programs,” he said.

FDA received 75 reports of depression, suicidal ideation, or suicide attempts related to Ozempic

Quoted by the chain NBCa 45-year-old American nurse recounted after being treated with Ozempic: “I was starting to have pretty depressing feelings, not suicidal, but very depressingI was just thinking about all the shit I’ve been through this past year.”

The woman said the endocrinologist who prescribed Ozempic did not ask her about that aspect of her health history. After stopping use of the drug, she said: “Without any doubt, I think she would have been on the cusp of ‘Do I end my life here?‘”.

Another American, 53, said she felt “totally depressed” two weeks after starting Ozempic. “She started off slow and then all of a sudden it was ‘Whoah!’ I felt suicidal. I was thinking of throwing my car off a cliff or something,” she recounted.

“I thought ‘I think this is the medicine that is doing this‘” he added.

The manufacturer of the indicated medicines, the Danish pharmaceutical company Novo Nordiskreacted to this news by saying that it remains “confident in the benefit-risk profile of the products” but takes reports of adverse effects seriously.

The company said it is “conducting continuous monitoring of data from ongoing clinical trials and the actual use of its products and works closely with the authorities to guarantee patient safety and adequate information to health professionals.

ds

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