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U.S. Department of Health and Human Services

Safety

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Sandostatin LAR Depot (octreotide acetate for injectable suspension)


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- March 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Cholelithiasis and Gallbladder Sludge
  • Hyperglycemia and Hypoglycemia
  • Thyroid Function Abnormalities

ADVERSE REACTIONS

  • Clinical Studies Experience
    • Acromegaly
    • Carcinoid and VIPomas
  • Postmarketing Experience

WARNINGS AND PRECAUTIONS

Cholelithiasis and Gallbladder Sludge

Sandostatin may inhibit gallbladder contractility and decrease bile secretion, which may lead to gallbladder abnormalities or sludge. Patients should be monitored periodically...

Hyperglycemia and Hypoglycemia

Octreotide alters the balance between the counter-regulatory hormones, insulin, glucagon, and growth hormone, which may result in hypoglycemia or hyperglycemia. Blood glucose levels should be monitored when Sandostatin LAR treatment is initiated, or when the dose is altered. Antidiabetic treatment should be adjusted accordingly...

Thyroid Function Abnormalities

Octreotide suppresses the secretion of thyroid stimulating hormone, which may result in hypothyroidism...