gar nicht gut. mal schauen, aber ein Plus wird das heute nicht
www.reuters.com/article/fda-valeant-pharm-in-idUSL4N1G060B
The approval for Siliq injection includes a labeling with boxed warning to mitigate the risk of suicide. Patients treated with Siliq during clinical trials had shown suicidal behavior, the FDA noted.
www.streetinsider.com/Corporate+News//...+by+FDA/12557385.html
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. Notable requirements of the Siliq REMS Program include the following:
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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