FDA investigates safety of new weight-loss drugs

The Food and Drug Administration (FDA) is looking into the potential side effects of a new class of weight-loss drugs that have gained popularity among celebrities and consumers. The drugs, which include Ozempic, Wegovy and Mounjaro, are designed to mimic a hormone that suppresses appetite and regulates blood sugar. However, they may also pose serious risks, such as stomach paralysis, rebound weight gain and complications during surgery.

The weight-loss drugs are based on a substance called semaglutide, which is a synthetic version of a hormone called GLP-1. GLP-1 is produced in the gut in response to food and signals the brain to stop eating. It also stimulates the pancreas to release more insulin, which lowers blood sugar levels.

FDA investigates safety of new weight-loss drugs
FDA investigates safety of new weight-loss drugs

Semaglutide was originally developed to treat type 2 diabetes, but it was found to have a significant effect on weight loss as well. Ozempic and Mounjaro are approved for diabetes, while Wegovy is the first drug to be approved specifically for obesity. The drugs are injected once a week under the skin and can help people lose up to 15% of their body weight in a year.

What are the benefits of the weight-loss drugs?

Obesity is a major public health problem that affects more than 2 out of 5 U.S. adults, according to the National Institute of Diabetes and Digestive and Kidney Diseases. Obesity increases the risk of various chronic diseases, such as heart disease, stroke, diabetes and some cancers. Losing weight can improve health outcomes and quality of life for people with obesity.

The weight-loss drugs offer a new option for people who struggle to lose weight with diet and exercise alone. They can also help people with diabetes lower their blood sugar and reduce their need for other medications. Some studies have shown that the drugs can also lower blood pressure, cholesterol and inflammation.

What are the risks of the weight-loss drugs?

The weight-loss drugs are not without their drawbacks, however. They can cause side effects, such as nausea, vomiting, diarrhea, constipation, headache and fatigue. They can also be expensive, costing up to $1,300 a month without insurance.

More importantly, the drugs may have serious consequences for some patients, especially if they are not used as directed. For example, a study from 2022 found that stopping semaglutide injections resulted in some rebound weight gain, which could undermine the long-term benefits of the treatment.

Another concern is that the drugs can affect the stomach’s ability to empty its contents, a condition known as gastroparesis or stomach paralysis. This can cause symptoms such as heartburn, acid reflux, bloating, nausea and malnutrition. It can also increase the risk of aspiration, which is when food or liquid enters the lungs and causes pneumonia.

Gastroparesis can be particularly dangerous for people who undergo surgeries that require sedation, such as colonoscopy, endoscopy or dental procedures. The American Society of Anesthesiologists recently warned that patients should discontinue taking the weight-loss drugs at least a week before such surgeries, as they can interfere with the anesthesia and cause complications.

The FDA is also investigating reports of pancreatitis, gallbladder disease, kidney injury and thyroid cancer associated with the weight-loss drugs. The agency has not confirmed a causal link between the drugs and these conditions, but it is advising health care providers and patients to report any adverse events to the FDA MedWatch program.

What are the alternatives to the weight-loss drugs?

The weight-loss drugs are not meant to be a magic bullet for obesity, but rather a tool to complement lifestyle changes, such as eating a healthy diet and exercising regularly. They are also not suitable for everyone, as they have certain contraindications and precautions. For example, they should not be used by pregnant or breastfeeding women, people with a history of pancreatitis or thyroid cancer, or people with severe kidney or liver problems.

There are other options for people who want to lose weight, such as behavioral counseling, nutrition education, weight-loss programs, supplements and surgery. However, none of these options are without their own risks and limitations, and they may not work for everyone. The best approach to weight loss is individualized and based on a person’s medical history, preferences and goals.

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