December 5, 2006: FDA to Review Suicide Risk for Young Adults Taking Antidepressants
The U.S. Food and Drug Administration (FDA) announced a December 13 meeting of outside medical experts who will consider new data on the increased risk of "suicidality" (suicidal thinking and behavior) in young adults taking antidepressant medications. This meeting is a follow-up to two meetings on antidepressants and suicidality in pediatric patients held in February and September, 2004. The FDA states that it plans to modify antidepressant drug labels based on the panel's findings.
July 2006: Combined Use of Symbyax and Migraine Medicines Risky
The U.S. Food and Drug Administration (FDA) issued a public health advisory concerning the use of Symbyax and other antidepressants. The FDA announced the risks associated with the combined use of selective serotonin reuptake inhibitors (SSRIs, such as fluoxetine found in Symbyax) and triptans (used to treat migraine headaches). Combined use can lead to a life-threatening condition called serotonin syndrome. Click here to read more.
July 2006: Treatment Challenges of Depression in Pregnancy
The FDA issued a public health advisory about the potential risks of using Symbyax and other antidepressants during pregnancy. The FDA announced the results of a study examining the use of antidepressant medicines during pregnancy by mothers of babies born with a serious condition called persistent pulmonary hypertension of the newborn (PPHN). Babies born with PPHN have abnormal blood flow through the heart and lungs, and do not get enough oxygen to their bodies. Click here to read more.
June 30, 2005: Suicidality in Adults Being Treated with Antidepressant Medications
The FDA issued a public health advisory announcing that several recent scientific publications suggested the possibility of an increased risk for suicidal behavior in adults being treated with antidepressant medications, such as Symbyax. The FDA highlighted that adults taking antidepressants (particularly those being treated for depression) should be watched closely for worsening depression and increased suicidality. Monitoring these patients is especially important when treatment begins, and when doses are increased or decreased. The FDA is working closely with antidepressant manufacturers to fully evaluate the risk of suicidality in adults treated with these medications. Click here to read more.
October 15, 2004: FDA Orders Re-Labeling on Suicidality in Child and Adolescent Antidepressant Patients
The FDA issued a public health advisory directing all antidepressant drug manufacturers to revise their product labeling to include boxed warning and expanded warning statements that alert healthcare providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these medications. Symbyax-maker Eli Lilly and Company has since added a black box warning to Symbyax's prescribing information in response to the FDA advisory. Click here to read more.
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