http://www.fda.gov/cder/drug/infopage/p ... efault.htm
FDA ALERT [12/2005]: Increase in the Risk of Birth Defects
Preliminary results of two recent studies indicate that paroxetine increases the risk of congenital malformations, particularly cardiovascular malformations. Based on the new data, paroxetine’s pregnancy category is being changed from C to D. Patients taking paroxetine who become pregnant or who are currently in their first trimester of pregnancy should be alerted to the potential risk to the fetus. Discontinuing paroxetine therapy or switching to another antidepressant should be considered for these patients. For individual patients, however, the benefits of continuing paroxetine may outweigh the potential risk to the fetus. Paroxetine should generally not be initiated in women who are in their first trimester of pregnancy or in women who plan to become pregnant.
The FDA is currently awaiting the final results of the recent studies and accruing additional data pertaining to the use of paroxetine in pregnancy in order to better characterize the risk of paroxetine. The FDA will update this sheet as new information becomes available.
This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about this information. FDA intends to update this sheet when additional information or analyses become available.
FDA ALERT [07/2005] – Suicidal Thoughts or Actions in Children and Adults
Patients with depression or other mental illnesses often think about or attempt suicide. Closely watch anyone taking antidepressants, especially early in treatment or when the dose is changed. Patients who become irritable or anxious, or have new or increased thoughts of suicide or other changes in mood or behavior (or their care givers) should contact their healthcare professional right away.
Children
Taking antidepressants may increase suicidal thoughts and actions in about 1 out of 50 people 18 years or younger. Although paroxetine is prescribed for children, FDA has not approved paroxetine for use in children.
Adults
Several recent scientific publications report the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medications. Even before these reports became available, FDA began a complete review of all available data to determine whether there is an increased risk of suicidal thinking or behavior in adults being treated with antidepressant medications. It is expected that this review will take a year or longer to complete. In the meantime, FDA is highlighting that adults being treated with antidepressant medication, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior.
This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.
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