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Drug Safety Communication: Certain Type of Medicines Approved for Type 2 Diabetes and Obesity - Update on FDA’s Ongoing Evaluation of Reports of Suicidal Thoughts or Actions

ISSUE: The FDA has been evaluating reports of suicidal thoughts or actions in patients treated with a class of medicines called glucagon-like peptide-1 receptor agonists (GLP-1 RAs; see the list in Table 1 below). These medicines are used to treat people with type 2 diabetes or to help those with obesity or overweight to lose weight. FDA's preliminary evaluation has not found evidence that use of these medicines causes suicidal thoughts or actions.

Over the last several months, the FDA has 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, the FDA determined that the information in these reports did not demonstrate a clear relationship with the use of GLP-1 RAs. Similarly, the FDA's reviews of the clinical trials, including large outcome studies and observational studies did not find an association between use of GLP-1 RAs and the occurrence of suicidal thoughts or actions. 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, the FDA cannot definitively rule out that a small risk may exist; therefore, the FDA is continuing to look into this issue.

Additional evaluations include a meta-analysis of clinical trials across all GLP-1 RA products and an analysis of postmarketing data in the Sentinel System. A meta-analysis is a large, combined analysis of findings from clinical trials. Sentinel is a very large data network that contains health insurance claims and patient health records that can be used to investigate safety questions about FDA-regulated products. The FDA will communicate final conclusions and recommendations after completion of the review or when there is more information to share.

BACKGROUND:

• GLP-1 RAs are a class of several medicines used to improve blood sugar (glucose) control and reduce the risk of heart disease in patients with type 2 diabetes. Some of these medicines are also used to help patients with obesity or overweight to lose weight.

RECOMMENDATIONS:

Patients

• You should not stop taking GLP-1 RAs without first consulting your health care professional, as stopping these medicines may worsen your condition.

• Talk to your health care professional if you have questions or concerns.

• Tell your health care professional if you experience new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior.

• Call or text 988 or go to the website at https://988lifeline.org/, which provides free support for people in distress 24 hours a day, 7 days a week.

Health Care Professionals

The current prescribing information for the GLP-1 RAs approved to treat patients with obesity or overweight contains information about the risk of suicidal thoughts and actions. This information is also included in the labels of other types of weight loss medicines and is based on reports of such events observed with a variety of older medicines used or tested for weight loss.

• Consistent with the prescribing information for these medications, health care professionals should monitor for and advise patients using GLP-1 RAs to report new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior.

• Health care professionals should consult the prescribing information when treating patients with these medications.

GLP-1 RAs are a class of several medicines (see list in Table 1) used to improve blood sugar (glucose) control and reduce the risk of heart disease in patients with type 2 diabetes. Some of these medicines are also used to help patients with obesity or overweight to lose weight. FDA approved the first GLP-1 RA in 2005, and there are now several in this class. GLP-1 RAs work by mimicking a hormone in the intestines called GLP-1 to stimulate the release of insulin and reduce blood glucose after eating a meal. These medicines also slow down food traveling through the digestive tract, which can help make someone feel full longer. GLP-1 receptors are also present in parts of the brain that regulate appetite.

Table 1. FDA-Approved GLP-1 RAs

**Tirzepatide is a dual gastric inhibitory polypeptide (GIP) receptor and GLP-1 RA.

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Related Information:

• Diabetes Medicines

• The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective

• Think It Through: Managing the Benefits and Risks of Medicines

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Source: FDA