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.
October 25, 2006: Effexor Maker Warns Doctors of Antidepressant Overdose Risk
Effexor manufacturer Wyeth sent a letter to health care providers informing them of changes to the antidepressant's Prescribing Information, and advising doctors to limit the number of pills they prescribe to each Effexor patient, due to the risk of overdose. According to Wyeth, "prescriptions for Effexor XR should be written for the smallestquantity of capsules consistent with good patient management, in orderto reduce the risk of overdose." Read the full Letter from Wyeth (in PDF format).
July 9, 2006: Group Criticizes Effexor Maker for Failure to Warn
The Medical Accountability Network, a private nonprofit organization dedicated to ethical issues in medicine, criticized Effexor maker Wyeth Pharmaceuticals for failing to adequately warn about the risk of 'homicidal ideation' associated with Effexor use. 'Homicidal ideation' (homicidal thoughts) was added to the Effexor XR label in November 2005, as one of the drug's rare adverse events. The Medical Accountability Network says that the warning was not well-publicized, and that Wyeth failed to send letters to doctors or issue warning labels announcing the change.
July 2006: FDA Says Combined Use of Effexor and Migraine Medicines Risky
The U.S. Food and Drug Administration (FDA) issued an alert concerning Effexor use. The FDA announced the risks associated with the combined use of selective serotonin reuptake inhibitors (SSRIs, such as Effexor) and triptans (used to treat migraine headaches). Combined use can lead to a life-threatening condition called serotonin syndrome. Click here to read more from the FDA.
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, including Effexor. The FDA advised 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 beings 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 Warns of Suicidality in Child and Adolescent Antidepressant Patients
The FDA issued a public health advisory directing all antidepressant drug manufacturers to revise their products' 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. Wyeth Pharmaceuticals, the manufacturer of Effexor, has since added a black box warning to the Effexor XR website in response to the FDA advisory.
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