The US registers and monitors new side effects of injectables to lose weight

After the secondary effects registered in the mental health of the users of the antidiabetic injectables, now others related to the sequelae in the gastrointestinal system are coming to light. American users report that they have many stomach problems after the use of Ozempic and Wegovy.

CNN collects testimonies that ensure that after a year of abandoning the use of these drugs, the discomfort still persists. In addition, the American chain ensures that the FDA has collected reports on these consequences and is working on their analysis before making a decision.. In June 2022, the US agency already included intestinal obstructions as a rare adverse event.

Specifically, there have been cases of gastroparesis. It is a rare pathology and rare side effect. It consists of a set of symptoms such as nausea and vomiting associated with abdominal distension and early satiety plus or less pain in the upper abdomen, caused by delayed gastric emptying without a physical cause or absence of mechanical obstruction..

It should be mentioned that semaglutide-based drugs, and others in that family, which includes drugs such as tirzepatide and liraglutide, act by imitating a hormone that the body produces naturally, GLP-1.. One of its functions is to slow down the passage of food through the stomach and this to feel satiated for longer.. One of the effects sought to treat obesity and the loss of kilos.

How has the slowing down of food in the stomach been measured?

It should be noted that a study carried out by Michael Camilleri, a gastroenterologist at the Mayo Clinic, has tried to answer this question.. Recruited 40 obese adult volunteers and randomly offered increasing doses of liraglutide or placebo. Camilleri regrets, as reported by CNN, that these types of studies have not been carried out in depth and, therefore, the idea that this type of medication delays gastric emptying is not so popular..

In the investigation, after five weeks the participants were subjected to a meal with a radioactive marker to see how long the food was in the stomach.. Digestion in people taking liraglutide slowed dramatically compared to the placebo group. Thus, half of what they ate took about 70 minutes to leave the stomach, compared to four minutes for the placebo.. These figures are just the average delay: in some who took the drug, the time it took for half of the food to pass through the intestine was 151 minutes, or more than 2.5 hours..

Camilleri's work also suggests that the group that took liraglutide lost weight, and the longer the delay in the exit of food from the stomach, the more weight they seemed to lose.. On the positive side, it is worth mentioning that the volunteers adapted to the drug over time.

After almost four months, members of the liraglutide group eliminated almost half of what they ate in about 30 minutes, compared with seven minutes on placebo.. In addition, nausea and vomiting also seemed to ease.. “It is conceivable that some patients may have borderline slow gastric emptying and starting one of the GLP-1 agonists may precipitate full-blown gastroparesis,” Camilleri told CNN..

What is the stomach paralysis that some patients have?

In gastroparesis or stomach paralysis, in the absence of a mechanical obstruction, gastric stasis, or marked slowing of stomach contents, may occur due to abnormalities in the process of normal gastrointestinal motor function..

All of this can be triggered by a series of complex events that require the coordination of the sympathetic and parasympathetic nervous systems, the neurons and pacemaker cells within the stomach and intestine, along with the smooth muscle cells of the intestine..

This is where the impact of the GPL-1 hormone alteration should be well studied, since it does not have the same effect in all patients..

What are the side effects registered by the EMA and the FDA?

The side effects registered in the data sheet include gastrointestinal disturbances, among others.. Specifically, de Wegovy mentions that nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, belching, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, illness gastroesophageal reflux and nasopharyngitis.

The Ozempic data sheet states that “In patients treated with semaglutide 0.5 mg and 1 mg, nausea occurred in 17% and 19.9%, respectively, diarrhea in 12.2% and 13.3% and vomiting in 6.4% and 8.4%. Most episodes were mild to moderate in severity and of short duration.. The episodes caused discontinuation of treatment in 3.9% and 5% of patients”.

On the other hand, Novo Nordisk states in the data sheet of its product, Saxenda, that “this medicine is not recommended if you have a serious stomach or intestine problem that causes delayed stomach emptying (called gastroparesis), or if you have an inflammatory bowel disease”-

Review by regulatory agencies in Europe and the US

Given the “almost massive” use of these drugs and the appearance of strange and infrequent side effects, the regulatory agencies in Europe and the US, EMA and FDA, respectively, are collecting data to verify the correlation between the use of the drugs and reported adverse events.

In Spain, a week ago the General Council of Pharmaceutical Colleges considered that, “at the moment, there is no cause for alarm” due to the evaluation that the EMA has initiated of the data on the possible “risk of suicidal thoughts and thoughts of self-harm “related to drugs known as agonists – which increase the activity of another – of the GLP-1 receptor, including Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide), used for weight loss and to treat type 2 diabetes.

The council specifies that among the “main pharmacological activities” of these medications, their ability to regulate blood glucose concentrations both fasting and after meals, decrease glucagon secretion, delay gastric emptying after meals, stands out. as well as reduce appetite and anxiety to eat.