LOS ANGELES, CALIFORNIA - In this photo illustration, boxes of the diabetes drug Ozempic rest on a pharmacy counter on April 17, 2023 in Los Angeles, California. Ozempic was originally approved by the FDA to treat people with Type 2 diabetes- who risk serious health consequences without medication. In recent months, there has been a spike in demand for Ozempic, or semaglutide, due to its weight loss benefits, which has led to shortages. Some doctors prescribe Ozempic off-label to treat obesity.
The FDA is “evaluating the need for regulatory action” after its FDA Adverse Event Reporting System or FAERS received reports of alopecia, or hair loss; aspiration, or accidentally breathing in things like food or liquid; and suicidal ideation in people using these medications.
“The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk,” the FAERS website notes. “It means that FDA has identified a potential safety issue, but it does not mean that FDA has identified a causal relationship between the drug and the listed risk.”
People who use these medications and have questions or concerns about side effects should speak with their health care provider, the FDA says.
“The FDA monitors the safety of drugs throughout their life cycle, including post-approval. In addition, the FDA maintains a system of postmarketing surveillance and risk assessment programs to identify and evaluate adverse events that did not appear during the drug development process,” the agency told CNN on Wednesday. “If newly identified safety signals are identified, the FDA will determine what, if any, actions are appropriate after a thorough review of available data.”
These actions may include requiring labeling changes or development of a Risk Evaluation and Mitigation Strategy, a program that helps ensure a medication’s benefits outweigh its risks.
Some research has linked GLP-1 agonists to serious digestive problems such as stomach paralysis, pancreatitis and bowel obstructions, although the risks of these events appear to be rare. Many of these side effects are mentioned in the drugs’ prescribing information or on their labels.
The American Society of Anesthesiologists recommended in June that people who use GLP-1 agonists stop taking them for a week before surgical procedures because of the potential for gastrointestinal problems like nausea, vomiting and delayed gastric emptying that may “increase the risk of regurgitation and pulmonary aspiration of gastric contents during general anesthesia and deep sedation.” Vomiting under anesthesia sometimes causes food and stomach acid to get into the lungs, which can cause pneumonia and other problems after surgery.
For months, European regulators have also been investigating the risk of suicidal thoughts in people taking these medications, although it’s not clear whether the medicines caused the events or whether they may be linked to other underlying conditions.
Novo Nordisk and Eli Lilly, which make a number of the GLP-1 agonists, said in statements that patient safety is their top priority and that they are working closely with the FDA to monitor safety.
The FDA is “evaluating the need for regulatory action” after its FDA Adverse Event Reporting System or FAERS received reports of alopecia, or hair loss; aspiration, or accidentally breathing in things like food or liquid; and suicidal ideation in people using these medications.
“The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk,” the FAERS website notes. “It means that FDA has identified a potential safety issue, but it does not mean that FDA has identified a causal relationship between the drug and the listed risk.”
People who use these medications and have questions or concerns about side effects should speak with their health care provider, the FDA says.
“The FDA monitors the safety of drugs throughout their life cycle, including post-approval. In addition, the FDA maintains a system of postmarketing surveillance and risk assessment programs to identify and evaluate adverse events that did not appear during the drug development process,” the agency told CNN on Wednesday. “If newly identified safety signals are identified, the FDA will determine what, if any, actions are appropriate after a thorough review of available data.”
These actions may include requiring labeling changes or development of a Risk Evaluation and Mitigation Strategy, a program that helps ensure a medication’s benefits outweigh its risks.
Some research has linked GLP-1 agonists to serious digestive problems such as stomach paralysis, pancreatitis and bowel obstructions, although the risks of these events appear to be rare. Many of these side effects are mentioned in the drugs’ prescribing information or on their labels.
The American Society of Anesthesiologists recommended in June that people who use GLP-1 agonists stop taking them for a week before surgical procedures because of the potential for gastrointestinal problems like nausea, vomiting and delayed gastric emptying that may “increase the risk of regurgitation and pulmonary aspiration of gastric contents during general anesthesia and deep sedation.” Vomiting under anesthesia sometimes causes food and stomach acid to get into the lungs, which can cause pneumonia and other problems after surgery.
For months, European regulators have also been investigating the risk of suicidal thoughts in people taking these medications, although it’s not clear whether the medicines caused the events or whether they may be linked to other underlying conditions.
Novo Nordisk and Eli Lilly, which make a number of the GLP-1 agonists, said in statements that patient safety is their top priority and that they are working closely with the FDA to monitor safety.
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