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Sunday, February 19, 2017 8:52:57 AM
Who's gonna buy this crap?
"Because of the observed risk of suicidal ideation and behavior, the labeling for Siliq includes a Boxed Warning and the drug is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Siliq REMS Program," as stated in the FDA’s press release.
The statement goes on to list requirements of the program, stating,
"Prescribers must be certified with the program and counsel patients about this risk. Patients with new or worsening symptoms of depression or suicidality should be referred to a mental health professional, as appropriate."
"Patients must sign a Patient-Prescriber Agreement Form and be made aware of the need to seek medical attention should they experience new or worsening suicidal thoughts or behavior, feelings of depression, anxiety or other mood changes."
"Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive Siliq."
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