To address the GLP-1 medication shortage, the U.S. Food and Drug Administration approved the first generic of once-daily GLP-1 injection to lower blood sugar in patients with type 2 diabetes.
The injection is for improving “glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes as an adjunct to diet and exercise,” according to FDA’s release.
The prescribing information “includes a Boxed Warning to advise healthcare professionals and patients about the increased risk of thyroid C-cell tumors. For this reason, patients who have had, or have family members who have ever had medullary thyroid carcinoma should not use liraglutide, nor should patients who have an endocrine system condition called multiple endocrine neoplasia syndrome type 2. In addition, people who have a prior serious hypersensitivity reaction to liraglutide or any of the product components should not use liraglutide. Liraglutide also carries warnings about pancreatitis, liraglutide pen sharing, hypoglycemia when used in conjunction with certain other drugs known to cause hypoglycemia including insulin and sulfonylurea, renal impairment or kidney failure, hypersensitivity and acute gallbladder disease. The most common side effects reported in the clinical trials for liraglutide injection include nausea, diarrhea, vomiting, decreased appetite, dyspepsia and constipation.”
