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Tuesday, October 3, 2023

Over 200 Cases Of Suicidal Thoughts After Taking Weight Loss Drugs: New Analysis

 by George Citroner via The Epoch Times (emphasis ours),

As Ozempic, Wegovy, and Mounjaro soar in popularity, the drugs are facing increasing scrutiny by regulators over reports of suicidal thoughts.

recent Reuters analysis reveals that over half of the adverse event reports by the U.S. Food and Drug Administration describe suicidal thoughts arising soon after starting or ramping up doses of these injectable drugs.

About 40 percent found relief after quitting the meds or taking a smaller dose.

(Madalina Vasiliu/The Epoch Times)

Popular Drugs Used for Weight Loss Have Been Under Fire Since July

Novo Nordisk’s Ozempic is approved to treat type 2 diabetes, while the company's Wegovy is approved for long-term weight management in obese or overweight adults. Mounjaro, a medication from Eli Lilly, is approved for blood sugar control in adults who have diabetes.

All three medications are part of a class of drugs, called glucagon-like peptide-1 (GLP-1) receptor agonists, and have been on regulators’ radar since at least this summer.

In July, the European Medicines Agency’s (EMA) safety committee initiated a review of data on the risk of suicidal and self-harm thoughts linked to the use of popular brands, including Ozempic and Wegovy, both containing the active ingredient semaglutide, and Saxenda, another medication approved for weight loss, which contains liraglutide.

An analysis of around 150 cases linked self-injury and suicidal ideation to these drugs soon after patients started taking them. The EMA expects this review to conclude in November.

Back in the U.S., the FDA's Adverse Events Reporting System (FAERS) has logged 6,253 serious adverse reports, including 163 deaths, tied to Ozempic since 2018. Wegovy has been linked to over 460 serious cases, with 6 fatalities since 2021, while Saxenda is associated with nearly 2,000 serious reports and 49 deaths since 2015.

Suicidal Thoughts: A Recurring Theme with Weight Loss Medications

Wegovy's label explicitly warns of potentially serious mental health side effects such as depression and suicidal thoughts. Patients are advised to monitor any sudden mood changes, behaviors, and feelings.

Similarly, liraglutide has been linked to suicidal thoughts and worsened depression in some patients.

A case reported by The Epoch Times spotlights the mental health risks. After starting Ozempic in February for his diabetes, a man became uncharacteristically withdrawn. By May, severe fatigue and declining mood set in. On May 14, he took his own life.

Weight loss medications provoking suicidal thoughts is not unprecedented. Sanofi’s weight loss drug rimonabant (Acomplia, Riobant, Slimona) was pulled from European markets in 2008 amidst concerns about suicidal ideation. Though unrelated to GLP-1 medicines, it reduced hunger through the endocannabinoid system, which serves as a connection between the body and the mind. Rimonabant was never approved in the U.S., due to psychiatric side effects.

Novo Nordisk Responds

In an emailed statement to The Epoch Times, Novo Nordisk said that patient safety is a top priority for the company and that they take all reports about adverse events from use of their medicines very seriously.

The drugmaker noted that GLP-1 receptor agonists like semaglutide and liraglutide have been on the market for over a decade, and have been used to treat type 2 diabetes for more than 15 years and obesity for over eight years.

In the U.S., the FDA requires medications for chronic weight management that work on the central nervous system, including Wegovy and Saxenda, to carry a warning about suicidal behavior and ideation, according to Novo Nordisk. "This event had been reported in clinical trials with other weight management products," the company noted.

Novo Nordisk remains confident in the benefit risk profile of the products and remains committed to ensuring patient safety,” the drugmaker added.

What is Suicidal Ideation?

Suicidal ideation, or thoughts related to wanting to kill oneself, are often associated with depression, “but some medications can certainly trigger a depressed mood and even suicidal thoughts,” Dr. Anna K. Costakis, director of psychiatry residency training at Northwell Staten Island University Hospital in New York, told The Epoch Times.

A well-known example is the anti-smoking medication Chantix. It was found to trigger suicidal thoughts in patients with or without depressive symptoms, and was required to include a black box warning by the FDA (pdf) in 2007. (The agency dropped the warning in 2016.)

It’s reasonable to associate “new or intense” thoughts of suicide with taking a new medication, Dr. Costakis said. “Immediately contacting your physician and discussing coming off the medication as quickly and safely as possible, is recommended,” she added.

For anyone experiencing suicidal thoughts, first reach out to loved ones who can help keep you safe. If the thoughts are uncontrollable, call 911 or go to the ER, Dr. Costakis noted.

If immediate safety can be ensured, notify your doctor to develop a safety plan and address the problematic medication. Additional resources include the 988 crisis line—which can also be texted—for free support and referrals.

Monday, October 2, 2023

Putin Orders First-Ever Nationwide Nuclear Drill, Prepares Bomb-Test At Arctic Circle

 Via Remix News,

Russia will hold its first nationwide drill simulating widespread nuclear strikes on the country, daily Magyar Hírlap writes.

The one-day nuclear attack exercise is based on the assumption that NATO will launch a nuclear strike on Russia, destroying 70 percent of Russian housing and life-support facilities. In the scenario, martial law is imposed in the country and a full-scale mobilization is ordered.

The test will also model the secondary threat posed by damage to nuclear power plants and other key facilities.

State and regional authorities will have to organize emergency rescue teams to provide food, medical supplies and protection against radiation.

According to the preparatory document, there is a need to prepare for an escalation of war, including a global conflict involving nuclear powers.

The permanent relocation of the population from the life-threatened zone will be similar to Chernobyl, involving an internal population transfer on an unprecedented scale.

Putin, meanwhile, is moving to one of his nuclear bunkers around the country to escape the simulated nuclear Armageddon. In the event of a real nuclear war, he has a fleet of “Doomsday” Il-80 Maxdome aircraft that can act as an air control center.

The exercise is being held four days before Putin’s 71st birthday.

Not only is the national disaster exercise seen as a training exercise for nuclear war, but preparations are also underway for a nuclear explosion test in the Arctic Circle.

Russian Defense Minister Sergei Soygu visited Novaya Zemlya in August, signaling that tests could soon resume after a break of several decades.

https://www.zerohedge.com/geopolitical/putin-orders-first-ever-nationwide-nuclear-drill-prepares-bomb-test-arctic-circle

Post-vaccine vaginal bleeding rates tied to all COVID-19 vaccine types across reproductive ages

 Research by the Norwegian Institute of Public Health, Norway, suggests that COVID-19 vaccines or the body's response to them can lead to unexpected vaginal bleeding in women. This phenomenon was observed in women across different reproductive stages.

In a paper, "Unexpected vaginal bleeding and COVID-19 vaccination in nonmenstruating ," published in Science Advances, the team of public health researchers detail their findings that raise the possibility that the spike protein of the SARS-CoV-2 virus, which is targeted by the vaccines, might be involved in this phenomenon.

The study investigated the association between COVID-19 vaccination and unexpected vaginal bleeding in non-menstruating postmenopausal, perimenopausal, and premenopausal women. The study included approximately 22,000 participants, aged 32 to 64, from the Norwegian Mother, Father and Child Cohort Study (MoBa) and the Senior cohort, ages 65 to 80.

Unexpected vaginal bleeding was reported in 3.3% of , 14.1% of perimenopausal women, and 13.1% of premenopausal women, more than three times the expected rates. Around half of the women who reported unexpected vaginal bleeding experienced it within 28 days after a COVID-19 vaccination.

The study suggests that the vaccine type may influence the risk of vaginal bleeding. The Spikevax (Moderna) vaccine, which contains a higher mRNA dose, was associated with a higher risk of vaginal bleeding than Comirnaty (PFIZER), particularly in premenopausal women.

Despite the physiological changes associated with hormonal intrauterine devices (IUDs) in premenopausal women, there were no apparent differences in the relative risk of bleeding across hormone use in the IUD group, which accounted for 74% of non-menstruating  in the study.

The lack of differentiation between prolonged , age and menopausal-related hormonal differences suggests that the mechanism is not through disruptions of the hypothalamic-pituitary-ovarian axis. In a population data study, biological mechanisms cannot be directly interrogated, but the observations provide the insights needed for effective follow-up investigations.

One of the study's limitations is the robust nature of the data related to post-COVID-19 vaccination effects. With high levels of reporting post-vaccination, there is a tremendous opportunity to collect data on a globally shared mass vaccination event, potentially connecting symptoms to the vaccinations. It also allows for disparate, unconnected data to be associated with the vaccination event as it is uniquely robust in  compared to any other event and can create the illusion of, or bias towards, connections with vaccination.

Unexpected vaginal bleeding is likely under-reported in normal circumstances and is a chronically understudied aspect of women's health. Only 31% of women who reported bleeding sought , and the proportion was even lower if the bleeding occurred post-vaccination.

Typical health-care-related databases would not have captured the current findings where medical care was not involved and would likely not have captured consultations where treatment was not offered to address the symptoms. It is unclear if similar events occur with other vaccines or medications, and it would be challenging to investigate within the data captured by current medical databases.

The current study bypassed the health care filter and collected reports directly from the women surveyed. Without this effort, the strong signals found in the reports and associations between specific vaccine types and the similarities across reproductive stages and hormone use would have been invisible. The results highlight the need for greater study, surveillance and reporting of health issues specific to women.

More information: Kristine Blix et al, Unexpected vaginal bleeding and COVID-19 vaccination in nonmenstruating women, Science Advances (2023). DOI: 10.1126/sciadv.adg1391


https://medicalxpress.com/news/2023-10-post-vaccine-vaginal-covid-vaccine-reproductive.html

Stryker corp: Citi price target reduced from USD 342 to USD 330.

 maintains its buy recommendation 

https://www.marketscreener.com/quote/stock/STRYKER-CORPORATION-14536/

Insulet corp: Jefferies upgrades to buy from hold

with a price target reduced from USD 260 to USD 240.

https://www.marketscreener.com/quote/stock/INSULET-CORPORATION-50468/

Abbott lab: Citi reduces the target price from USD 130 to USD 122.

 maintains its buy recommendation

https://www.marketscreener.com/quote/stock/ABBOTT-LABORATORIES-11506/

Amgen inc: Barclays target raised from USD 210 to USD 230.

 maintains its underweight recommendation

https://www.marketscreener.com/quote/stock/AMGEN-INC-4847/