Label Changes for:

Symlin (pramlintide acetate) injection

June 2014

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.


 

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

 

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. Read about the new physician labeling format.


 

June 2014

Summary View

WARNINGS AND PRECAUTIONS
 

Patient Selection
  • Proper patient selection is critical to the safe and effective use of Symlin. Before initiating Symlin, the patient’s HbA1c, recent blood glucose monitoring data, history of insulin-induced hypoglycemia, current insulin regimen, and body weight should be reviewed. Symlin therapyshould only be considered in patients with type 1 diabetes or patients with type 2 diabetes using mealtime insulin who fulfill the following criteria...
Hypoglycemia
  • Symlin alone does not cause hypoglycemia. However, SYMLIN is indicated to be coadministered with mealtime insulin therapy, and in this setting there is an increased risk of
    severe hypoglycemia, particularly in patients with type 1 diabetes. If severe hypoglycemia associated with Symlin occurs, it is usually seen within the first 2 to 3 hours following a SYMLIN injection. If severe hypoglycemia occurs while operating...

ADVERSE REACTIONS

Postmarketing Experience
 
  • The following adverse reactions have been identified during post-approval use of SYMLIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not
    always possible to reliably estimate their frequency or establish a causal relationship to drug
    exposure.
  •  Injection site reactions
  •  Pancreatitis

 

AUGUST 2008

Summary View

Sections Modified

ADVERSE REACTIONS

  • Postmarketing Experience (new subsection)
    • General
      • Injection Site Reactions

Label approved 08/04/2008 is not available on this site

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