Home Medizin FDA bewertet 3 Nebenwirkungen, die für Medikamente zur Gewichtsreduktion gemeldet wurden

FDA bewertet 3 Nebenwirkungen, die für Medikamente zur Gewichtsreduktion gemeldet wurden

von NFI Redaktion

The FDA is officially investigating reports that some people taking popular diabetes and weight-loss medications have experienced suicidal thoughts or two other health issues.

A new FDA report listed possible associations between the medications and a hair loss condition called alopecia, a swallowing issue that can occur during a surgery called aspiration, or suicidal thoughts, CBS News reported. The investigation is focusing on reports of health problems in people taking so-called GLP-1 receptor agonists, including Ozempic, Wegovy, Mounjaro, and Zepbound. These medications are used to treat diabetes and obesity.

An FDA investigation does not mean the FDA has concluded that there is a risk, the FDA risk assessment website warns.

„It means that the FDA has identified a potential safety issue, but it does not mean that the FDA has determined a causal relationship between the drug and the listed risk,“ the FDA website says.

Possible next steps after an investigation could include updating drug labels with new information, implementing a risk management plan to avoid or address health risks, or gathering additional information.

„The FDA monitors the safety of drugs throughout their entire lifecycle,“ even after the drugs are approved. Additionally, the FDA uses „monitoring and risk assessment programs to identify and evaluate adverse events that have not occurred during the drug development process,“ FDA spokesperson Chanapa Tantibanchachai said in an email published by several news agencies.

Even if an investigation may not result in changes to how a drug is regulated by the FDA, this is not the first time that popular medications have been on the FDA’s radar for re-evaluating their safety. Last year, the label for the drug Ozempic was updated to account for reports of bowel obstruction, CBS News reported.

European regulatory agencies are also examining reports of suicidal thoughts in people taking GLP-1 receptor agonists, although no connection has been established.

Concerns about aspiration during surgery led the American Society of Anesthesiologists to advise in June that people discontinue taking GLP-1 receptor agonists before undergoing a planned operation.

„While there is currently a lack of scientific data on how GLP-1 receptor agonists affect patients undergoing surgery and interacting with anesthesia, we have received isolated reports that delayed stomach emptying may be associated with an increased risk of regurgitation and aspiration of food into the airways and lungs during general anesthesia and deep sedation,“ said the society’s president, Dr. Michael W. Champeau, in a statement at the time.

According to CBS News, the FDA’s Adverse Event Reporting System links the medications to 201 reports of suicide or suicidal thoughts, 18 reports mentioning aspiration, and 422 reports mentioning alopecia.

Drug manufacturer Novo Nordisk, which includes Wegovy and Ozempic in its portfolio, told CNN that it is working with the FDA to monitor safety and is aware of reports of side effects.

„Novo Nordisk stands behind the safety and effectiveness of all of our GLP-1RA medications when taken as directed under the supervision of a licensed healthcare professional,“ the company said in a statement to CNN.

A spokesperson for Eli Lilly, which produces Mounjaro and Zepbound, told CBS News in a statement, „The FDA is currently reviewing data on potential risks for GLP-1 receptor agonist medications. Patient safety is a priority for us, and we are working with the FDA to bring these potential signals to their attention.“

***SOURCES:
– CBS News: „Possible side effects of Ozempic, including hair loss and suicidal thoughts, investigated by the FDA.“
– CNN: „FDA investigates reports of hair loss and suicidal thoughts in people taking popular diabetes and weight loss medications.“
– European Medicines Agency: „Highlights of the Pharmacovigilance Risk Assessment Committee (PRAC) meeting 27-30 November 2023.“
– American Society of Anesthesiologists: „Patients taking common diabetes and weight loss medications should stop before planned surgery, ASA suggests.“***

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