David Baxter PhD
Late Founder
'Natural antidepressant' linked to increases in suicidal behavior
Wed, Apr 23 2008
Merck Serono UK has issued revised product information for its prescription only 'Optimax? Tablets 500 mg' containing the amino acid L-Tryptophan. L-Tryptophan is a pre cursor for serotonin, a neurotransmitter linked to anxiety and depression. L-Tryptophan has been promoted as a natural antidepressant.
The changes are the addition to 4.4 Special warnings and precautions for use of:
Wed, Apr 23 2008
Merck Serono UK has issued revised product information for its prescription only 'Optimax? Tablets 500 mg' containing the amino acid L-Tryptophan. L-Tryptophan is a pre cursor for serotonin, a neurotransmitter linked to anxiety and depression. L-Tryptophan has been promoted as a natural antidepressant.
The changes are the addition to 4.4 Special warnings and precautions for use of:
Suicide/suicidal thoughts or clinical worsening
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
and the following addition to 4.8 Undesirable effects of: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Cases of suicidal ideation and suicidal behaviours (frequency not known) have been reported during L-tryptophan therapy or early after treatment discontinuation (see section 4.4).
Revised Optimax? Tablets 500 mg product information.