Toxicity of Paroxetine and Escitalopram on Breastfed Infants - Research Proposal Example

WHAT IS THE SHORT- AND LONG-TERM TOXICITY OF PAROXETINE AND ESCITALOPRAM ON BREASTFED INFANTS WHOSE MOTHERS ARE ON POSTPARTUM DEPRESSION TREATMENT? Abstract Medical literature describes three type of postpartum mood disorders, which are postpartum depression, postpartum blues and, and postpartum psychosis. Whereas the last two are relatively common, and account for nearly 80% of the postpartum mood disorder population, but resolve on their own and over a period of time; it is postpartum depression that offers a major clinical challenge since it is not self-limiting. Postpartum depression thus meets DSM-IV criteria for a major depressive episodes, lasting a few weeks (Campbell 1991). Women with major depressive history or history associated with previous pregnancy are at major risk. While the condition has been shown to have negative developmental impact on breastfed infants of these mothers, the use of antidepressants on them and their subsequent effects on infants through breast milk has always been a debate of concern. The risks have been shown to outweigh at least in case of short-term exposure to antidepressants during breastfeeding, where further investigation is on to determine the long-term effects on infants. Under this background this paper intends to determine both short and long-term effects of two such antidepressants, paroxetine and escitalopram on breastfed infants whose mothers are on postpartum depression treatment. Introduction On an average, around 13% of women who recently given birth, suffer from postpartum depression. Considered as a natural aftermath of the birth-giving process, it often goes unrecognized, underestimated, or undertreated. This can have a significant impact on the life of the infant being nursed , since studies have noted associations between maternal depression and impaired maternal-infant interactions(Murray at al 1996)), cognitive and emotional development(ref), and anxiety and lower self-esteem (Beck 1998)). When medical professional understand the need for treating postpartum depression in mothers, the only deterrent coming in the way of their use is about their potential adverse effects on the nursing infant (Politano et al 1992). These concerns have been highlighted by several studies and behavioral outcomes and infant serum levels have been reported for breastfeeding newborns from mother treated by one or more types of antidepressants including selective serotonin reuptake inhihibtors (SSRIs) and tricyclic antidepressants (TCAs). These studies have reported infant serum levels of antidepressants, rather than anitdepressants’ concentrations in the breast milk. This is because serum levels as against breast milk are medically recognized as direct determinants of the drug exposure to antidepressants used on mother (Stowe et al 1997). This has prompted certain drug regulatory authorities, like USFDA, not to recommend any antidepressants to mothers when they are breastfeeding (Yoshida & Kumar 1996). Several studies (Table 1) have provided information of clinical utility on transmission of antidepressants to nursing infants, even though there were some inherent methodological weaknesses associated with these studies, like low sample size, varying parameters between different studies even though goal to be established was one, and more importantly a relatively short-term follow up lasting from a week to a few month during the course of treatment but not beyond that period. Table 1. Antidepressant Drug Therapy in Breastfeeding Mothers: Infant Serum Drug Levels and Behavioral Outcomes Study No. of Infants Maternal Dose Infant Age (weeks) Infant Serum Drug Levels (Lower Limit of Detection)* Adverse Infant-Related Clinical Outcomes Selective Serotonin Reuptake Inhibitors (SSRIs)  Citalopram (Celexa)   Jensen et al, 1997 1 20 mg/day 8 7 ng/mL None   Schmidt et al, 2000 1 40 mg/day 6 12.7 ng/mL Uneasy sleep, normalized with dose reduction   Rampono et al, 2000 7 0.36 mg/kg/day (median) Not detected; 2.3 ng/mL (1 ng/mL) None   Spigset et al, 1997 3 20–40 mg/day 8–16 Not discussed None  Fluoxetine (Prozac)   Brent & Wisner, 1998 1 20 mg/day 2–3 61 ng/mL Limp, unresponsive, cyanotic (mother also taking carbamazepine and buspirone)   Burch & Wells, 1992 1 20 mg/day 17 Not discussed None   Chambers et al, 1999 64 Not given 2–24 Not discussed Lower growth curves (average deficit of 392 g)   Hendrick et al, 2001 20 10–60 mg/day 0–31 Fluoxetine, Read More