The US Food and Drug Administration (FDA) has said, its preliminary review of a class of medicines called glucagon-like peptide-1 receptor agonists (GLP-1 Ras), did not show links to suicidal thoughts or actions.
These medicines are used in treating Type 2 diabetes and obesity and though they are expensive, some of these drugs including semaglutide, liraglutide and duraglutide, for example, are sold in India by companies including Novo Nordisk, Eli Lily, Glenmark and Lupin, to name a few.
The US regulator did, however, say it would continue to review the drug, given that a small risk may exist.
“Patient selection is important for these medicines, so only those patients who are motivated, co-operative and stick to the diet and exercise course are given these drugs”, explains David Chandy, Consultant Endocrinologist at Mumbai’s Sir HN Reliance Foundation Hospital. It is usually not given to those with Type 2 diabetes if the patient is lean; and in the case of obesity, a counsellor is involved, if there are signs of depression, Chandy toldto businessline.
When a patient is started on this class of drugs, they are monitored and if there is anything “off-track”, a psychologist is brought in to counsel the person, he said. There is a co-relation between obesity and depression, he pointed out, as those with depression tend to have eating disorders.
In fact, says Chandy, endocrinologists watch out for depression and the risk of suicidal thoughts with anti-obesity drugs, given the precedent with Rimonabant, he said, that was banned about 15 years ago. The drug was taken of the shelves after regulators in the US and Europe expressed concern over links to psychiatric problems.
Regulators on GLP-1
In the latest review, the USFDA said, “Over the last several months, we have conducted detailed reviews of reports of suicidal thoughts or actions received in the FDA Adverse Event Reporting System (FAERS). Because the information provided was often limited and because these events can be influenced by other potential factors, we determined that the information in these reports did not demonstrate a clear relationship with the use of GLP-1 Ras.”
Further, it added, “However, because of the small number of suicidal thoughts or actions observed in both people using GLP-1 RAs and in the comparative control groups, we cannot definitively rule out that a small risk may exist; therefore, FDA is continuing to look into this issue. “
Last July, the European Medicines Agency said, its safety committee, was reviewing data on the risk of suicidal thoughts and thoughts of self-harm with medicines known as GLP-1 receptor agonists,1 including Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide). “The review was triggered by the Icelandic medicines agency following reports of suicidal thoughts and self-injury in people using liraglutide and semaglutide medicines,” it added.
Pointing out that these drugs needed to be taken in a precise manner on an empty stomach, Chandy said, being motivated to comply was important and brought out the best results.