On this photo illustration, boxes of the diabetes drug Ozempic rest on a pharmacy counter in Los Angeles, April 17, 2023.
Mario Tama | Getty Images
The European Union’s drug regulator on Tuesday said it has broadened an investigation into the chance of suicidal thoughts and self-injury amongst patients taking Novo Nordisk‘s Ozempic, Wegovy and Saxenda drugs to incorporate other weight reduction and diabetes medications.
The European Medicines Agency didn’t specify which additional drugs are actually included within the investigation, nevertheless it could potentially include Eli Lilly‘s diabetes drug Mounjaro, which is approved within the EU. Other firms akin to Pfizer and Amgen are developing similar products.
The EMA said it’s now evaluating about 150 reports of possible cases of self-injury and suicidal thoughts in patients taking weight reduction and diabetes drugs. It’s still unclear if the medicines caused the events or whether or not they are linked to patients’ underlying conditions or other aspects, the statement said.
The EMA expects to complete its probe in November, in keeping with a press release.
On Monday, the agency told CNBC it launched an investigation into the matter after the Icelandic Medicines Agency flagged three cases of suicidal thoughts and self-injury in patients doping up containing liraglutide and semaglutide.
Liraglutide is the lively ingredient in Novo Nordisk’s weight reduction drug Saxenda. Semaglutide is the lively ingredient within the Danish company’s weight reduction injection, Wegovy, and its diabetes counterpart, Ozempic.
Liraglutide and semaglutide are a part of a category of highly popular drugs called GLP-1 receptor agonists.
They mimic a hormone produced within the gut called GLP-1 to suppress an individual’s appetite and ultimately aid with weight reduction. Those drugs may help people manage Type 2 diabetes because they encourage insulin release from the pancreas, lowering blood sugar levels.
Novo Nordisk said in a press release to CNBC on Monday that “safety data collected from large clinical trial programs and post marketing surveillance haven’t demonstrated a causal association between semaglutide or liraglutide and suicidal and self-harming thoughts.”
The corporate said it’s “constantly performing surveillance of the information from ongoing clinical trials and real-world use of its products and collaborates closely with the authorities to make sure patient safety and adequate information to healthcare professionals.”
The EMA’s investigation could potentially establish latest unwanted side effects related to blockbuster drugs akin to Wegovy and Ozempic, that are already known to cause nausea, vomiting and diarrhea.
Suicidal behavior isn’t currently listed as a side effect within the EU product information for any GLP-1 receptor agonists.
The U.S. prescribing information for Novo Nordisk’s Saxenda, approved by the Food and Drug Administration, also doesn’t list suicidal thoughts or self-injury as unwanted side effects. However it does include a suggestion to observe patients for depression or suicidal thoughts and to discontinue the drug if symptoms develop.
Clinical trials in adults found nine of three,300 people on Saxenda reported suicidal ideation. That is compared with two of greater than 1,900 people on a placebo. The prescribing information says “there was insufficient information to ascertain a causal relationship to Saxenda.”
There isn’t any similar warning within the U.S. prescribing information for Ozempic.
Wegovy’s U.S. prescribing information notes suicidal ideation and behavior have been reported in clinical trials for other weight management products. Patients on Wegovy ought to be monitored for depression and suicidal thoughts or behavior, the data says.
In case you are having suicidal thoughts, contact the Suicide & Crisis Lifeline within the U.S. at 988 or the Samaritans within the U.K. at 116 123.