December 5, 2006: FDA to Review Suicide Risks for Young Adults Taking Antidepressants
US Food and Drug Administration declared in a December 13 meeting with outside medical professionals who would consider new data on the higher chances of “suicidality”, a condition characterized by suicidal thoughts and behavior, among young adults who were taking antidepressant medicines. The meeting was a follow-up of the two meetings held about antidepressants and suicidality in pediatric patients conducted in February and September 2004. The US FDA stated that it was planning to change antidepressant drug labels based on the findings of the panels.
July 2006: Combined Use of Lexapro and Migraine Medicines are Risky
US Food and Drug Administration has released a public health advisory about the use of Lexapro and other antidepressants. FDA said that there were high risks related with the combined use of selective serotonin reuptake inhibitors or SSRI such as Lexapro, and the triptans which are used for the treatment of migraine headaches. The combined used of these medicines can result to life-threatening condition known as serotonin syndrome.
July 2006: Treatment Challenges of Depression in Pregnancy
US FDA released a public health advisory regarding the probable risks of using Lexapro and other antidepressants during the pregnancy. FDA also announced the results of a study conducted which assessed the use of antidepressants during pregnancy period of mothers of babies who were born with PPHN. These babies with PPHN have abnormal flow of the blood through the heart and lungs, and do not get sufficient oxygen to their human bodies.
June 30, 2005: Suicidality in Adults Being Treated with Antidepressant Medicines
Another public health advisory was released by the US Food and Drug Administration revealing about some recent scientific publications that suggested the probability of higher risks of suicidal behavior among adults being treated with antidepressants like Lexapro. FDA has stressed that adults who are taking antidepressants should watch thoroughly for worsening symptoms of depression and increased suicidality. It is recommended to monitor and check these patients when the treatment started and when the dosage was increased or reduced. FDA is working closely with the manufacturers of antidepressant medicines to completely assess the risks of suicidality among adults being treated with these medicines.
October 15, 2004: FDA Orders Re-Labeling on Suicidality in Child and Adolescent Antidepressant Patients
FDA released a public advisory requiring all manufacturers of antidepressant medicines to modify their product labeling and include boxed warning and expanded warning statements to the healthcare providers about the increased risks of suicidality among children and adolescents being treated with antidepressants. Forest Laboratories Inc, the manufacturer of Lexapro, added a black box warning to Lexapro’s prescribing information in adherence to the advisory of the US FDA.