Patients of All Ages on Antidepressants Should be Monitored Warns FDA

The FDA Black Box warnings increase.

Some of our readers are not up to date on that Black Box Warnings found on antidepressants.  Black Box Warnings that were made mandatory on antidepressants by the FDA (U.S. Food and Drug Administration) are no longer just targeted at young children, adolescents or young adults.  See the excerpt below found on your typical antidepressant:

“…Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber… “*

June 30, 2005: The FDA issued a Public Health Advisory entitled “Suicidality in Adults Being Treated with Antidepressant Medications.” The advisory states that several recent scientific publications suggest the possibility of an increased risk of suicidal behavior in adults taking antidepressants and while a review of all available data is being undertaken by the FDA, it is recommended that physicians should monitor adults who take antidepressants for suicidal tendencies.**

Additional Warnings Include:

October 17, 2005: The FDA ordered Eli Lilly & Co. to add a warning to its latest depression drug, Cymbalta, that it can cause liver damage.***

October 19, 2005: A University of Southern California study reinforced the earlier FDA warnings that antipsychotic drugs increase the risk of death in the elderly.****

*Source of Black Box Warning: Celexa (antidepressant)

** Source:  “Suicidality in Adults Being Treated with Antidepressant Medications,” FDA Public Health Advisory, 30 June 05.

*** Source: 2005 Safety Alerts for Drugs, Biologics, Medical Devises, and Dietary Supplements,” FDA MedWatch, 17 Oct. 05.

**** Source: Lori Oliwenstein, “Study Notes Risks of Antipsychotic Drugs,” University of Southern California Public Relations, 21 Oct. 05.

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