Recent studies have shown that adolescents who take antidepressants have an increased risk of suicide. The FDA proposes that warning labels be placed on these medications. There is a debate over whether the labels will educate patients and enable them to make an informed decision or cause patients to go without medication they need. The warning is intended to make patients and their families aware of possible side effects of antidepressants.
The current proposal applies to patients under the age of eighteen. However, the FDA recommends that the warning be issued to those aged 18-24 when they begin taking the drugs. In the study, adults over the age of 24 showed no increase in suicidal thoughts and those aged 65 or older actually showed a decrease.
Drug makers have said they will comply with the FDA’s request in order to help families make an informed decision. Spokesperson for Pfizer has said they would update the label but that there was no link between their product and suicide.
The FDA website, www.fda.gov, has a list of medications for which the new labeling process will affect. The FDA issued a statement to patients taking the medication that they should not stop taking the medication and anyone who had concerns about the medication they were taking should consult their physician. Stopping your antidepressant medication without consulting your physician can cause other symptoms
Manufacturers will have 30 days in which to revise the labels and send them to the FDA for review. At this time all drug makers have agreed to the new labeling standards. The FDA website has a complete outline of what the new labels should say and how they should be worded.
The FDA strongly recommends that patients read the guide that comes with any medication you are prescribed. They also recommend you contact your healthcare provider if your symptoms change or you notice new symptoms. It is also important to note that not all antidepressant drugs are approved for use with children.
This announcement follows the agreement in 2006 that healthcare professionals as well as patients needed to be made aware of the possible side effects of antidepressant medications in children. The FDA states that you should take no action if your symptoms seem to be relieved while on these medications, however if you notice your symptoms worsening or have suicidal thoughts you should immediately consult your physician.
Sources:
http://apnews.myway.com/article/20070503/D8OSKT001.html May 3, 2007
http://apnews.myway.com/article/20070503/D8OSKT001.html May 3, 2007
http://www.fda.gov/cder/drug/antidepressants/default.htm May 3, 2007
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01624.html May 3, 2007
http://www.fda.gov/cder/drug/antidepressants/antidepressants_MG_2007.pdf May 3, 2007
