Safety

Somatuline Depot (Lanreotide) Injection

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

December 2014

Summary View

WARNINGS AND PRECAUTIONS

*The following was added:

Cardiovascular Abnormalities
  • … In 81 patients with baseline heart rates of = 60 beats per minute (bpm) treated with SOMATULINE DEPOT in Study 3, the incidence of heart rate < 60 bpm was 23% (19/81) as compared to 16 % (15/94) of placebo treated patients; ten patients (12%) had documented heart rates < 60 bpm on more than one visit. The incidence of documented episodes of heart rate < 50 bpm as well as the incidence of bradycardia reported as an adverse event was 1% in each treatment group. Initiate appropriate medical management in patients who develop symptomatic bradycardia…

November 2013

Summary View

ADVERSE REACTIONS

Postmarketing Experience
  • cholecystitis
  • steatorrhea

 

Page Last Updated: 01/15/2015
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