December 5, 2006: FDA to Review Suicide Risk for Young Adults Taking Antidepressants
UD Food and Drug Administration released an announcement of a December 13 meeting with those outside of medical professionals who could consider new data on the health risks particularly the suicidality, characterized by suicidal thinking and behavior, among the young adults who are taking antidepressant medication. The meeting was a follows up from the two meetings regarding antidepressants and suicidality among the pediatric patients which was conducted last February and September 2004. FDA claimed that it planned to alter antidepressant drug labels which were based on the findings of the panel.
October 25, 2006: Effexor Maker Warns Doctors of Antidepressant Overdose Risk
Wyeth, the manufacturer of Effexor, sent message to healthcare professional to notify them of the changes to the antidepressant’s Prescribing Information and advising the doctors to restrict the number of pills they prescribe to patients using Effexor because of the probable risks of overdose. According to Wyeth, the prescription for Effexor XR should be written for the smallest number of capsules consistent with the patient’s management to lower the risks of overdose.
July 9, 2006: Group Criticizes Effexor Maker for Failure to Warn
The Medical Accountability Network, a private nonprofit association committed to the ethical issues in medicines, have criticized Wyeth Pharmaceuticals, the producer of Effexor, for failure to warn regarding the risks of “homicidal ideation” related with the use of Effexor. The “Homicidal ideation” or homicidal thoughts where placed to the Effexor XR label in November 2005, as one of the drug’s uncommon adverse events. The Medical Accountability Network stated that the warning was not well-publicized and Wyeth failed to send notices to the doctors or issue warning labels stating the changes.
July 2006: FDA Says Combined Use of Effexor mad Migraine Medicines Risky
US Food and Drug Administration released a warning about the use of Effexor. FDA declared the risks associated with the combined use of selective serotonin reuptake inhibitors or SSRIs like Effexor and triptans which help treat migraine headaches. The combined use may result to a life-threatening condition known as serotonin syndrome.
June 30, 2005: Suicidality in Adults Being Treated with Antidepressant Medications
FDA issued a public health advisory stating that there are recent scientific publications that recommended the probability of increased risks for suicidal behavior among adults who are treated with antidepressant treatment which includes Effexor. FDA said that adults who are taking antidepressants, especially those who are treated for depression, must be monitored closely for worsening depression and increased suicidality. By checking these patients, it is important to note when the treatment started and when the dosage was increased. FDA is working closely with antidepressant producers to assess completely the probable risks of suicidality among adults who are treated with these medications.
October 15, 2004: FDA Warns of Suicidality in Child and Adolescent Antidepressant Patients
FDA released a public health advisory instructing ll antidepressant drug manufacturers to modify the labeling of their products and include boxed warning and expanded the warning statements that warned healthcare providers to increased potential risks of suicidality, suicidal thinking and behavior, among children and adolescents who are treated with these medications. Wyeth Pharmaceuticals, the producer of Effexor, placed a box warning to the Effexor XR website in answer to the FDA instructions.