FDA Probes Ozempic, Other Weight-Loss Drugs for Suicidal Risks

by Denis Storey
January 4, 2024 at 2:24 PM UTC

The FDA said it’s looking into multiple cases of hair loss, aspiration, and suicidal ideation in those who’ve used popular weight-loss drugs.

Clinical Relevance: Adverse reactions associated with GLP-1 receptor agonists (GLP-1 RA) include suicidal ideation

  • A new FDA investigation is also looking into other side effects of the drugs including multiple cases of hair loss and aspiration.
  • The FDA’s scrutiny follows a previous investigation over a year ago, where reports of these medications causing intestinal blockages were examined.
  • Anesthesia experts also warned patients to cease taking these drugs before elective procedures due to potential complications related to stomach emptying.

It should come as no surprise that with the effectiveness – and subsequent popularity – of weight-loss drugs such as Mounjaro (tirzepatide) regulators would enter the fray.

In its latest quarterly adverse reaction report, which dropped earlier this week, the U.S. Food and Drug Administration (FDA) announced it’s looking into multiple cases of hair loss, aspiration, and suicidal ideation in those who’ve used GLP-1 receptor agonists (GLP-1 RA).

“We’re aware that, as part of those monitoring efforts, [the] FDA is evaluating several potential signals related to GLP-1 RA medicines and has posted information about those ongoing assessments on its website,” a Novo Nordisk spokesperson told CBS News. “Novo Nordisk stands behind the safety and efficacy of all of our GLP-1 RA medicines when they are used as indicated and when they are taken under the care of a licensed healthcare professional.”

Weight-Loss Drugs Catch Regulators Attention

The FDA’s already had its investigators look into this increasingly popular new class of weight-loss drugs. More than a year ago, regulators investigated reports of the medications causing intestinal blockages. While no litigation came from it, at least one manufacturer, Novo Nordisk, has since added the side effect to its labels.

And news of the FDA’s renewed interest in these drugs follows a June 2023 announcement from the American Society of Anesthesiologists, which warned patients to stop taking them before elective procedures.

“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, M.D., wrote announcing the recommendation. “These complications can be serious, so we are providing guidance on when GLP-1 agonists should be stopped in advance of an elective procedure.”

From Diabetes Relief to Weight Reduction

Doctors have been prescribing GLP-1s for type 2 diabetes for nearly 20 years. But lately, doctors have embraced them as the go-to prescription for obesity since the FDA approved its use for weight loss a decade ago. So much so that the journal Science declared it the Breakthrough of 2023.

“The drugs didn’t really catch fire until two years ago, when Novo Nordisk’s next iteration, semaglutide, was greenlit for weight management in the U.S. (It’s marketed as Ozempic for diabetes and Wegovy for obesity),” the journal reported. “Unlike its forerunners, semaglutide required an injection just weekly rather than once or twice a day. And in a pivotal trial, people taking it lost an unprecedented 15% of their body weight over about 16 months. Many on the drug also describe a dampening of ‘food noise,’ the relentless and distressing desire to keep eating.”

But these drugs have done more than offer a lifeline for patients with obesity. They’ve managed to force a cultural shift in the way the medical community approaches obesity as a whole. Doctors are increasingly treating it as a disease like diabetes and hypertension.

One Person’s Story

The outlet added that 1.7 percent of U.S. citizens have received a prescription for either Wegovy or Ozempic in 2023.  One of those patients, Rebecca, has been taking Mounjaro – then its weight-loss-branded equivalent, Zepound, for more than a year.

“GLP-1s have changed my life,” she explained. “Years of diet and exercise not working told me that something in my metabolism just wasn’t working. However, as someone who’s experienced most of the side effects possible, I will say that it’s as critical to be consistent with hydration, magnesium citrate, fiber, and probiotics as it is to take the medicine. If I use tirzepatide only, the emptying of my stomach can come to a near standstill. This causes nausea symptoms far beyond the usual 1-2 days after the shot

“I recently added in digestive enzymes to my meal times so that I don’t have proteins and fats just hanging out in my stomach and fermenting,” she continued. “That causes gas, bloating, reflux, and constipation. My body works best on these meds when it’s a lower fat content, higher in vegetable fiber that’s been roasted and well cooked down, and soup or stew-like consistency.”

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