Wednesday, August 16, 2023

#JamesDonaldson On #MentalHealth – Ozempic, Other GLP-1 #Drugs Under Safety Review For Risk Of #SuicidalThoughts

#JamesDonaldson On #MentalHealth – Ozempic, Other GLP-1 #Drugs Under Safety Review For Risk Of #SuicidalThoughts
A man looking out a window.Ozempic and other GLP-1 drugs are currently under safety review in several countries after a small number of cases have reported an increase in #suicidalthoughts while taking the medications

- GLP-1 drugs like Ozempic, Wegovy, and Trulicty are under safety review following reports that the medications may cause #suicidalideation.

- The risk of #suicidalthoughts is not currently listed as a potential side effect of GLP-1 drugs.

- A handful of cases have reported #suicidalthoughts and #self-harming #behavior in people using GLP-1 medications.

- Research shows no evidence of a direct cause between GLP-1 #drugs and #suicidalideation.

Semaglutide (sold under the brand names Ozempic and Wegovy) as well as other GLP-1 medications that can aid with #weightloss are currently under safety review for the potential risk of increasing #suicidalthoughts.



Following a relatively small number of cases reporting #suicidalthoughts and #self-harming #behavior in people using GLP-1 receptor agonists, agencies in CanadaEurope, and the United Kingdom are assessing whether the side effect is caused by the medication or is associated with underlying conditions.



Suicidal thoughts are not currently listed as a potential side effect of Ozempic, according to the U.S. Food and Drug Administration’s drug label and the EU product information.



Along with Ozempic and Wegovy, here are some other GLP-1 #drugs currently under review:



- AstraZeneca’s medication exenatide (Bydureon)

- Eli Lilly’s dulaglutide (Trulicity)

- Sanofi’s lixisenatide

- Sanofi’s Soliqua

“GLP-1 receptor agonists have been used to treat type 2 diabetes for more than 15 years and for treatment of #obesity for 8 years, including Novo Nordisk products such as semaglutide and liraglutide that have been on the market for more than 10 years,” Novo Nordisk, Ozempic’s manufacturer, said in a statement. Semaglutide is the active medical ingredient in Ozempic.



“The safety data collected from large clinical trial programs and post-marketing surveillance have not demonstrated a causal association between semaglutide or liraglutide and suicidal and #self-harming thoughts,” the company said.



Ozempic and other GLP-1 drugs are not directly linked with #suicidalideation



#James Donaldson notes:
Welcome to the “next chapter” of my life… being a voice and an advocate for #mentalhealthawarenessandsuicideprevention, especially pertaining to our younger generation of students and student-athletes.
Getting men to speak up and reach out for help and assistance is one of my passions. Us men need to not suffer in silence or drown our sorrows in alcohol, hang out at bars and strip joints, or get involved with drug use.
Having gone through a recent bout of #depression and #suicidalthoughts myself, I realize now, that I can make a huge difference in the lives of so many by sharing my story, and by sharing various resources I come across as I work in this space.
  #http://bit.ly/JamesMentalHealthArticle
Find out more about the work I do on my 501c3 non-profit foundation
website www.yourgiftoflife.org Order your copy of James Donaldson's latest book,
#CelebratingYourGiftofLife: From The Verge of Suicide to a Life of Purpose and Joy


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“At this time, GLP-1 drugs like Ozempic have not been directly linked or even evaluated for a potential link to #suicidalideations,” said Dr. Mirela Loftus, PhD, medical director for Newport Healthcare.



“There has been no causal effect documented in any literature,” said Dr. Steven Batash, FACG, a gastroenterologist currently affiliated with NYU Medical Center, Lenox Hill Hospital, and NewYork-Presbyterian Hospital to Healthline. Batash provides endoscopic weight loss procedures or non-surgical #weightloss.



He adds that in his practice, he hasn’t come across anyone experiencing #suicidalthoughts after taking a GLP-1 receptor agonist.



“The manufacturers deny that #suicidalthoughts were reported during their trials,” said Dr. Jodie Pepin, clinical pharmacy program director at Harbor Health and an assistant professor of pharmacy at the University of Texas in Austin.



“As far as the newly reported #suicidalthoughts possibly related to the GLP-1s, there will have to be an abundance of evidence that proves causation, not just correlation,” she said.



Pepin also explains that millions of people have taken these medications, and the more people who take them, the more likely these side effects will show up.



“The numbers of #suicidalthoughts are relatively small compared to the number of prescriptions written for these medications,” she adds.



“The population who takes these medications have comorbidities or underlying conditions that may influence their response to drugs,” she tells Healthline.



Examples include pre-existing #mentalhealthconditions like #depression or comorbidities like heart disease, which can often be associatedTrusted Source with #depression, she adds.



“These responses may have little or nothing to do with the medication they are taking,” she said.



What to know before taking GLP-1 medications



Be sure to discuss your concerns about side effects from GLP-1 drugs with your #doctor.



GLP-1s are intended for people with higher BMIs

GLP-1 medications mimic the hunger hormones that suppress appetite and promote satiety or a feeling of fullness.



“We have to remember that medications like Ozempic and Wegovy are meant for people who are over a BMI of 30 or 27 with one comorbidity,” said Batash.



“These medications are frequently used off-label for people who are below a 27 BMI,” he adds.



“Please remember that these medications got approved for weight loss only recently and we don’t know long-term side effects of these medications and dosages that are currently taken for weight loss,” he told Healthline.



Black box warnings provide crucial safety information about GLP-1 drugs

Pepin said the safety warnings around the GLP-1 drugs are very explicit in the prescribing information.



“A Black Box Warning, or the most serious type of warning that can be included in prescribing information, is common among these medications,” she said.



The FDA warning is to avoid these GLP-1 agonist medications if you have a history of or a family history of:



- medullary thyroid cancer because the GLP-1s may cause an increased risk of this type of cancer

- pancreatitis, so it is recommended to avoid the #drugs in people with a history of pancreatitis or at risk of pancreatitis

“Side effects of these medications can be pretty severe, and if your quality of life is affected, you should look for other methods that can help you lose weight,” said Batash.



GLP-1s are not a sustainable long-term solution for #weightloss

Batash said these medications are not a long-term solution for #weightloss unless you are willing to commit to a lifetime of taking them.



He also said you will need to consider the cost of medication use over a long period of time, asking yourself if it makes sense to spend large amounts of money to use medication that may not be medically necessary.



Pepin agrees. “People should consider the cost of the #drugs because they are very expensive, particularly when taken for #weightloss.”



“Very few, if any, insurance companies will pay for them,” she said.



What to do if you have #suicidalthoughts while taking Ozempic or other GLP-1 #drugs



“You should always be aware and be well-informed of all possible side effects of medications you are taking,” said Batash.



“It is important to be under medical supervision while taking any of the medications but especially ones that can affect your #mentalhealth,” he added.



“If you feel like you might be experiencing any of the side effects listed for medications that you are taking, it is important to inform your medical provider immediately.”



There are a few more things to consider if you’re taking a GLP-1 medication and experiencing suicidal thinking.



First, Pepin recommends the person call a #suicidehotline or their #therapist if they have one, immediately.



If you or your loved one experiences #suicidalthoughts, thoughts of #self-harm, or extreme #hopelessness, call the #NationalSuicidePreventionLifeline, for free and confidential support at #988.



Then, Pepin suggests that the person contact their provider as soon as possible and have a discussion regarding the continuation or discontinuation of the #drug.



“The provider can look at the individual’s health history and comorbidities to determine, if in their clinical judgment, it is prudent to continue the medication or not,” she said. “A risk-benefit analysis should also be done to aid in this situation,” said Pepin.



Batash echoes this, noting that it’s important for any #physician who is prescribing these medications to do a screening.



“A #patient who has history of having #mentalhealthissues or experience #suicidalthoughts should not be prescribed GLP-1 agonists for #weightloss or #diabetes and should be strongly cautioned about potential side effects,” said Batash.



A man looking out a window.
https://standingabovethecrowd.com/2023/08/jamesdonaldson-on-mentalhealth-ozempic-other-glp-1-drugs-under-safety-review-for-risk-of-suicidalthoughts/

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