Fluoxetine Tablet while Breastfeeding

Modern medicine has evolved so much so that sooner or later every breastfeeding mother needs to take it in one form or other. Medication that is present in mothers blood will transfer into her breast milk to some extent. Most drugs do so at low levels and pose no real risk to infants but then there are some exceptions. In This post will discuss whether Fluoxetine Tablet is safe in breast-feeding or not.

What is Fluoxetine Tablet used for?


1. INDICATIONS AND USAGE Fluoxetine tablets are indicated for the treatment of: Major Depressive Disorder (MDD). The efficacy of fluoxetine tablets in MDD was established in one 5-week trial, three 6-week trials, and one maintenance study in adults. The efficacy of fluoxetine tablets was also established in two 8- to 9-week trials in pediatric patients 8 to 18 years of age [see Clinical Studies (14.1)]. Obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). The efficacy of fluoxetine tablets in OCD was demonstrated in two 13-week trials in adults and one 13-week trial in pediatric patients 7 to 17 years of age [see Clinical Studies (14.2)]. Binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa. The efficacy of fluoxetine tablets in Bulimia Nervosa was demonstrated in two 8-week trials and one 16-week trial in adults [see Clinical Studies (14.3)]. Panic Disorder, with or without agoraphobia. The efficacy of fluoxetine tablets in Panic Disorder was demonstrated in two 12-week trials in adults [see Clinical Studies (14.4)]. Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of: Major Depressive Disorder (MDD) (1) Adults: Efficacy was established in one 5-week trial, three 6-week trials, and one maintenance study (14.1) Pediatrics: Efficacy was established in two 8- to 9-week trials of patients 8 to 18 years of age (14.1) Obsessive Compulsive Disorder (OCD) (1) Adults: Efficacy was established in two 13-week trials (14.2) Pediatrics: Efficacy was established in one 13-week trial in patients 7 to 17 years of age (14.2) Bulimia Nervosa (1) Adults: Efficacy was established in two 8-week trials and one 16-week trial (14.3) Panic Disorder, with or without agoraphobia (1) Adults: Efficacy was established in two 12-week trials (14.4)

Is Fluoxetine Tablet usage safe while breastfeeding? If a lactating mother is using it can there be any effect on growth or development of infant?

Fluoxetine Tablet low risk for breastfeeding
Fluoxetine is the one and only active ingredient present in Fluoxetine Tablet. Fluoxetine in itself is a low risk drug for lactation so it is easy to understand that Fluoxetine Tablet also comes in category of Low Risk item while breastfeeding. Below is the summary of Fluoxetine in breastfeeding.

Statement of Manufacturer/Labeler about breastfeeding usage
8.3 Nursing Mothers Because fluoxetine is excreted in human milk, nursing while on fluoxetine is not recommended. In one breast-milk sample, the concentration of fluoxetine plus norfluoxetine was 70.4 ng/mL. The concentration in the mother’s plasma was 295.0 ng/mL. No adverse effects on the infant were reported. In another case, an infant nursed by a mother on fluoxetine developed crying, sleep disturbance, vomiting, and watery stools. The infant’s plasma drug levels were 340 ng/mL of fluoxetine and 208 ng/mL of norfluoxetine on the second day of feeding.

Fluoxetine Tablet Breastfeeding Analsys


Fluoxetine while Breastfeeding

Low Risk

CAS Number: 54910-89-3

Higher excretion into breast milk than other related antidepressant drugs. The active metabolite called Norfluoxetine has a longer half-life (4 to 16 days). Like other antidepressant drugs may induce hyperprolactinemia and galactorrhea. Few cases of colicky pain, irritability, insomnia, anorexia and slow weight gain have been described. However, most reported cases have failed to show harm effect outside the newborn period. Large experience with the use of Fluoxatine did not find harm effect on weight gain and neurological development of infants either at short or long term. Most problems have appeared in the early neonatal period either in newborns or premature infants whose mothers were on Fluoxetine during pregnancy. Stop or switch to other medication either at some days before delivery or in the first month postpartum would be recommended. Same considerations should be done in case of prematurity, however, medication must be continued if necessary. Women on anti-depressant treatment are in need of stronger support because of higher risk of breastfeeding failure.


Fluoxetine Tablet Breastfeeding Analsys - 2


Fluoxetine while Breastfeeding

CAS Number: 54910-89-3

The average amount of drug in breastmilk is higher with fluoxetine than with most other SSRIs and the long-acting, active metabolite, norfluoxetine, is detectable in the serum of most breastfed infants during the first 2 months postpartum and in a few thereafter. Adverse effects such as colic, fussiness, and drowsiness have been reported in some breastfed infants. Decreased infant weight gain was found in one study, but not in others. No adverse effects on development have been found in a few infants followed for up to a year. If fluoxetine is required by the mother, it is not a reason to discontinue breastfeeding. If the mother was taking fluoxetine during pregnancy or if other antidepressants have been ineffective, most experts recommend against changing medications during breastfeeding. Otherwise, agents with lower excretion into breastmilk may be preferred, especially while nursing a newborn or preterm infant. The breastfed infant should be monitored for behavioral side effects such as colic, fussiness or sedation and for adequate weight gain. Mothers taking an SSRI during pregnancy and postpartum may have more difficulty breastfeeding, although this might be a reflection of their disease state.[1] These mothers may need additional breastfeeding support. Breastfed infants exposed to an SSRI during the third trimester of pregnancy have a lower risk of poor neonatal adaptation than formula-fed infants.



I am nursing mother and I have already used Fluoxetine Tablet, what should I do?

During whole lactation period you shall first discuss with your doctor and then together you shall decide whether you shall take that drug or not however if you have already taken Fluoxetine Tablet then you shall inform your doctor, But you should not be worried too much as Fluoxetine Tablet comes in category of low risk drug.


I am nursing mother and my doctor has suggested me to use Fluoxetine Tablet, is it safe?

Though Fluoxetine Tablet dose not comes in category of safe drugs rather it comes in category of low risk but if your doctor is aware that you are breastfeeding your baby and has still recommended it then its advantages must be outweighing the risks.


If I am using Fluoxetine Tablet, will my baby need extra monitoring?

Not much


Who can I talk to if I have questions about usage of Fluoxetine Tablet in breastfeeding?

US
National Womens Health and Breastfeeding Helpline: 800-994-9662 (TDD 888-220-5446) 9 a.m. and 6 p.m. ET, Monday through Friday

UK
National Breastfeeding Helpline: 0300-100-0212 9.30am to 9.30pm, daily
Association of Breastfeeding Mothers: 0300-330-5453
La Leche League: 0345-120-2918
The Breastfeeding Network supporter line in Bengali and Sylheti: 0300-456-2421
National Childbirth Trust (NCT): 0300-330-0700

Australia
National Breastfeeding Helpline: 1800-686-268 24 hours a day, 7 days a week

Canada
Telehealth Ontario for breastfeeding: 1-866-797-0000 24 hours a day, 7 days a week