Psy-World - News from the agencies

Psy-World

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News from the Agencies
Recent developments from the FDA, EMEA
and other agencies
related to psychiatry and psychotropic drugs

FDA warns of abnormal heart rhythms associated with high doses of citalopram. Doses of citalopram greater than 40 mg per day should no longer be used because of a risk of abnormal changes in the electrical activity of the heart in particular prolongation of the QT interval of the ECG which can lead to an abnormal heart rhythm (including Torsade de Pointes), which can be fatal. Patients at particular risk for developing prolongation of the QT interval include those with underlying heart conditions and those who are predisposed to low levels of potassium and magnesium in the blood. Studies did not show a benefit in the treatment of depression at doses higher than 40 mg per day. Previously, the citalopram drug label stated that certain patients may require a dose of 60 mg per day. Further information. (August 2011)

WPA (World Psychiatric Association) issues its fourth guidance paper which deals with protection and promotion of mental health in children of persons with severe mental disorders. The three earlier guidances dealt with (1) steps, obstacles and mistakes to avoid in the implementation of community mental health care (June 2010); (2) how to combat stigmatization of psychiatry and psychiatrists (october 2010) and (3) mental health and mental health care in migrants (February 2011). Link to the WPA Guidance Papers (available in many languages). (July 2011)

The WPA-WHO publish their joint Global Survey of Psychiatrists’ Attitudes Towards Mental Disorders Classification.The WPA-WHO Global Survey asked 4,887 psychiatrists in 44 countries about their use of diagnostic classification systems in clinical practice, and the desirable characteristics of a classification of mental disorders. The WHO will use these results to improve the clinical utility of the ICD classification of mental disorders through the current ICD-10 revision process. Read the full report. (July 2011)

FDA warns of CNS reactions when either the antibacterial, linezolid, or methylene blue is given to patients on serotonergic psychiatric medication. Although the exact mechanism of this interaction is unknown, both linezolid and methylene blue inhibit the action of monoamine oxidase A—an enzyme responsible for breaking down serotonin in the brain. It is believed that when linezolid is given to patients taking serotonergic psychiatric medications, high levels of serotonin can build up in the brain, causing toxicity. This is referred to as Serotonin Syndrome—signs and symptoms include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination, and/or fever. Further information (linezolid); Further information (methylene blue) (July 2011)

The FDA approves new indication for duloxetine. On November 4th the FDA approved duloxetine (Cymbalta) for the treatment of chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain. The approval was based on clinical trials involving over 600 patients with osteoarthritis and chronic low back pain. In addition, trials involving more than 29,000 patients were used for the safety evaluation. Since its first approval for major depressive disorder in 2004 duloxetine has also been approved for the treatment of diabetic peripheral neuropathy in 2004; generalized anxiety disorder and maintenance treatment of major depression in 2007; and fibromyalgia in 2008. FDA presse release (November 2010)

Updated September 2011

	FDA warns of abnormal heart rhythms associated with high doses of citalopram. Doses of citalopram greater than 40 mg per day should no longer be used because of a risk of abnormal changes in the electrical activity of the heart in particular prolongation of the QT interval of the ECG which can lead to an abnormal heart rhythm (including Torsade de Pointes), which can be fatal. Patients at particular risk for developing prolongation of the QT interval include those with underlying heart conditions and those who are predisposed to low levels of potassium and magnesium in the blood. Studies did not show a benefit in the treatment of depression at doses higher than 40 mg per day. Previously, the citalopram drug label stated that certain patients may require a dose of 60 mg per day. Further information. (August 2011)
	WPA (World Psychiatric Association) issues its fourth guidance paper which deals with protection and promotion of mental health in children of persons with severe mental disorders. The three earlier guidances dealt with (1) steps, obstacles and mistakes to avoid in the implementation of community mental health care (June 2010); (2) how to combat stigmatization of psychiatry and psychiatrists (october 2010) and (3) mental health and mental health care in migrants (February 2011). Link to the WPA Guidance Papers (available in many languages). (July 2011)
	The WPA-WHO publish their joint Global Survey of Psychiatrists’ Attitudes Towards Mental Disorders Classification.The WPA-WHO Global Survey asked 4,887 psychiatrists in 44 countries about their use of diagnostic classification systems in clinical practice, and the desirable characteristics of a classification of mental disorders. The WHO will use these results to improve the clinical utility of the ICD classification of mental disorders through the current ICD-10 revision process. Read the full report. (July 2011)
	FDA warns of CNS reactions when either the antibacterial, linezolid, or methylene blue is given to patients on serotonergic psychiatric medication. Although the exact mechanism of this interaction is unknown, both linezolid and methylene blue inhibit the action of monoamine oxidase A—an enzyme responsible for breaking down serotonin in the brain. It is believed that when linezolid is given to patients taking serotonergic psychiatric medications, high levels of serotonin can build up in the brain, causing toxicity. This is referred to as Serotonin Syndrome—signs and symptoms include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination, and/or fever. Further information (linezolid); Further information (methylene blue) (July 2011)
	The FDA approves new indication for duloxetine. On November 4th the FDA approved duloxetine (Cymbalta) for the treatment of chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain. The approval was based on clinical trials involving over 600 patients with osteoarthritis and chronic low back pain. In addition, trials involving more than 29,000 patients were used for the safety evaluation. Since its first approval for major depressive disorder in 2004 duloxetine has also been approved for the treatment of diabetic peripheral neuropathy in 2004; generalized anxiety disorder and maintenance treatment of major depression in 2007; and fibromyalgia in 2008. FDA presse release (November 2010)