Suicidal Ideation and Behavior

• Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. 
• Prior to prescribing, weigh potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. Patients with new or worsening suicidal thoughts and behavior should be referred to a mental health professional, as appropriate. 
• Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes. 
• SILIQ is available only through a restricted program called the SILIQ REMS Program.