Saturday, August 26, 2023

Popular Weight-Loss Drugs Linked to Stomach Paralysis, Suicide and More

 

Popular Weight-Loss Drugs Linked to Stomach Paralysis, Suicide and More

Just two months after the European Medicines Agency (EMA) issued a safety signal citing concerns about a possible link to all types of thyroid cancer in people using Ozempic, doctors are sounding the alarm on even more dangerous health risks associated with the popular weight loss and diabetes medication. Negative health outcomes reportedly associated with the popular weight-loss drugs include stomach paralysis, potential surgery complications, and an increased suicide risk.1 2

Semaglutide, sold under brand names like Ozempic, Wegovy, and Mounjaro, promotes significant weight loss by mimicking the naturally occurring hormone GLP-1, which slows the passage of food through the stomach and keeps people feeling fuller longer. However, for a growing number of consumers, the drug slowed digestion so much that it causes severe gastroparesis or stomach paralysis. Doctors are reporting more and more cases of that rare but irreversible condition following the widespread use of the new weight loss drugs, with latent effects of gastroparesis including cyclic vomiting syndrome—a condition that causes patients to vomit multiple times per day even after stopping use of the drug.2 2

Semaglutide-Related Gastroparesis Can Exacerbate Diabetes, Cause Deadly Complications

Gastroparesis is a long-term, chronic condition that not only affects quality of life but can have deadly complications in some cases, including exacerbating diabetes, the chronic condition the drug was approved by the U.S. Food and Drug Administration (FDA) to help manage it in the first place. The delayed movement of food through the digestive tract can cause unpredictable and dangerous blood sugar changes that can lead to heart attack, stroke, and damage to vital organs. Dehydration from persistent vomiting can also result in malnutrition, which can be life-threatening.3

Ozempic drugmaker Novo Nordisk, in response to growing reports of gastroparesis in consumers, said in a statement, “Gastrointestinal (GI) events are well-known side effects of the GLP-1 class. For semaglutide, the majority of GI side effects are mild to moderate in severity and of short duration. GLP-1’s are known to cause a delay in gastric emptying, as noted in the label of each of our GLP-1 RA medications. Symptoms of delayed gastric emptying, nausea and vomiting are listed as side effects.”4

American Society of Anesthesiologists Warns of Serious Surgery Complications Following Ozempic Use

Gastroparesis is not the only stomach-related side effect heightening health concerns: The American Society of Anesthesiologists (ASA) warned last month that patients who continue using Ozempic prior to elective surgeries that include anesthesia can cause food regurgitation, even if they have fasted, resulting in stomach acid penetrating the lungs, causing pneumonia and other serious problems.

“While there is currently a lack of scientific data on how GLP-1 receptor agonists affect patients having surgery and interact with anesthesia, we’ve received anecdotal reports that the delay in stomach emptying could be associated with an increased risk of regurgitation and aspiration of food into the airways and lungs during general anesthesia and deep sedation,” ASA President Michael W. Champeau, MD said in the July press release. “These complications can be serious, so we are providing guidance on when GLP-1 agonists should be stopped in advance of an elective procedure.”5

U.K. and E.U. Reviewing Suicide Reports Linked to Ozempic and Wegovy in Multiple Countries

The pitfalls of the burgeoning Ozempic craze don’t stop at an increased thyroid cancer risk, chronic, long-term stomach paralysis, and serious surgery complications. In fact, United Kingdom health authorities are currently investigating a correlation between suicidal thoughts and the type-2 diabetes and weight loss drugs after the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) received reports of suicidal and self-injurious behavior between 2020 and 2023.4

Drugmaker Novo Nordisk responded to the report, saying, “We are currently reviewing safety data on the risk of suicidal thoughts and thoughts of self-harm associated with medicines known as GLP-1 receptor agonists, used for treating both type 2 diabetes and weight loss,’ she says. “We will carefully consider all available evidence and communicate any further advice to patients and healthcare professionals as appropriate.” Authorities in the European Union (E.U.) launched a similar investigation of the GLP-1 drugs a couple weeks earlier.6

FDA Lists Depression and Suicidal Thoughts as Potential Side Effects of Wegovy

As weight loss medications historically affect the nervous system, the FDA does require such drug packaging to display a warning about suicidal thoughts—but since Ozempic is only FDA-approved to treat diabetes and weight loss is an off-label prescription, no such warning exists on its packaging.

Wegovy, however, is the only FDA-approved GLP-1 medication for weight loss and the manufacturer product insert does list depression and suicidal thoughts as potential side effects. Therefore, while public health officials reiterate that the mounting reports of self-harm and suicidal thoughts aren’t proven to be causally related to semaglutide, Wegovy’s drug packaging does give some warning about “mental changes:

You should pay attention to any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you,” Wegovy’s Indication and Important Safety Information states.

As of June 30, 2023, the FDA received 190 reports of depression and suicide-related mental illnesses connected to Ozempic, along with 84 reports connected to Saxenda and 26 to Wegovy. A representative for Novo Nordisk said in a statement that the drugmaker is “committed to ensuring patient safety,” and “remains confident in the benefit-risk profile of the products.”8 9

Weight Loss Therapy Market to Exceed $100 Billion by End of Decade

As some pharmaceutical companies like Pfizer are considering cost cuts after demand for COVID products has plunged, the Ozempic frenzy has propelled drugmaker Novo Nordisk to Europe’s second-most valuable company with earnings and shares continuing to skyrocket to record highs. An expedited FDA review of Tirzepatide, also known as Mounjaro, is also in the works—along with over a dozen other weight loss therapies currently in development—after phase 3 clinical trials of the newer drug were published in July. Tirzepatide is currently approved to treat type-2 diabetes but manufacturer Eli Lily seeks to gain approval for weight loss.10 11

While Pfizer anticipates an uptick in its currently underperforming vaccines and antiviral treatments in the fall when COVID cases are projected to rise, the market for weight loss therapies has gained significant momentum and is slated to exceed $100 billion by the end of the decade.12


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