Increased risk of suicidality in children and young adults
-In line with FDA’s requirement that manufacturers of all antidepressant medications update the black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, to include young adults ages 18 to 24 during initial treatment (generally the first one to two months), the following language is suggested for consent forms in studies in which antidepressant medications will be given:
-The FDA has warned that antidepressant medications may increase suicidal thoughts or actions in some children, teenagers, and young adults when the medicine is first started. You should pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings, especially when an antidepressant medicine is first started or when the dose is changed. Call your doctor right away to report any new or sudden changes in mood, behavior, thoughts or feelings. Keep all scheduled follow-up appointment with your doctor. Call your doctor between visits if you have any concerns about symptoms. Do not stop taking your antidepressant medicines without consulting your doctor.
Increased risk of fractures in adults over the age of 50 who are taking SSRIs:
-A study by J. Brent Richards, et al, in the January 22, 2007 issue of Archives of Internal Medicine, and other recent studies, have demonstrated a likely association of SSRIs with increased fragility fractures in elderly adults. The Board determined that this represents a significant new finding, which may relate to willingness of participants to continue in a research study, and must be provided to study participants. (45CFR46.116b)(5). Some suggested wording is:
-Recent studies of depression in older men and women show that there may be a connection between the use of the antidepressants of the kind given in this study, a risk of bone fractures, and a decrease in bone density (loss of “bone strength”) at the hip and spine in men and women. You may wish to discuss this information with the study doctor to see if or how it relates to your use of the study medication.
Other side effects of antidepressant medications:
-Other risks and side effects must also be included. These might include anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania (unusual energy, speaking and thinking faster than usual, feeling more powerful unrelated to the situation or the way you usually feel), mania (racing thoughts, speaking in a fast and pressured way, not needing to sleep, overspending, showing more sexual interest than usual).
PAXIL WarningWomen who take Paroxetine (Paxil) during the first 3 months of pregnancy or who become pregnant while taking Paxil are at greater risk of having a baby born with hearing defects.
FDA Safety Communication re: High doses of Citalopram (CELEXA)FDA has clarified dosing recommendations for the antidepressant Celexa (citalopram). Because of the potential risk of abnormal heart rhythms at higher doses, Celexa should not be used at doses greater than 40 mg/day in most patients, and no greater than 20 mg/day for patients over the age of 60. (See attached)