Regulators will continue to evaluate a possible link by reviewing meta-analysis of clinical trials across all GLP-1 products and analyzing postmarketing data in the Sentinel System.
A preliminary FDA review of GLP-1 drugs used to treat patients with type 2 diabetes or obesity finds there is no evidence they cause suicidal thoughts or actions, regulators said in a safety communication. But because the risk cannot be ruled out, regulators will continue to evaluate these drugs.
Regulators have over the last few months reviewed the reports of suicidal thoughts or actions received in the FDA Adverse Event Reporting System (FAERS) related to these drugs. (See below for list of drugs that have evaluated for this risk.) Because the information provided was often limited and because these events can be influenced by other potential factors, regulators said there wasn’t a clear link with the use of GLP-1.
They also reviewed results of clinical trials, including large outcome studies and observational studies and did not find an association between use of GLP-1 and the occurrence of suicidal thoughts or actions.
Regulators will conduct additional evaluations, including of meta-analysis of clinical trials across all GLP-1 products and also analyze postmarketing data in the Sentinel System. Sentinel is a large data network that contains health insurance claims and patient health records.
FDA-Approved GLP-1 Drugs
Source: FDA
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
Read More
FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Read More