Mopart Pregnancy

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• Pregnancy of Mopart in details
• Mopart breastfeeding
• Mopart reviews

Pregnancy of Mopart in details

Mopart crosses the placenta (Hendrick 2003). An increased risk of teratogenic effects, including cardiovascular defects, may be associated with maternal use of Mopart or other SSRIs; however, available information is conflicting. Nonteratogenic effects in the newborn following SSRI/SNRI exposure late in the third trimester include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypo- or hypertonia, hyper-reflexia, jitteriness, irritability, constant crying, and tremor. Symptoms may be due to the toxicity of the SSRIs/SNRIs or a discontinuation syndrome and may be consistent with serotonin syndrome associated with SSRI treatment. Persistent pulmonary hypertension of the newborn (PPHN) has also been reported with SSRI exposure. The long-term effects of in utero SSRI exposure on infant development and behavior are not known.

Due to pregnancy-induced physiologic changes, some pharmacokinetic parameters of Mopart may be altered. The maternal CYP2D6 genotype also influences Mopart plasma concentrations during pregnancy (Hostetter 2000; Ververs 2009).

The manufacturer suggests discontinuing Mopart or switching to another antidepressant unless the benefits of therapy justify continuing treatment during pregnancy; consider other treatment options for women who are planning to become pregnant. The ACOG recommends that therapy with SSRIs or SNRIs during pregnancy be individualized; treatment of depression during pregnancy should incorporate the clinical expertise of the mental health clinician, obstetrician, primary health care provider, and pediatrician. The ACOG also recommends that therapy with Mopart be avoided during pregnancy if possible and that fetuses exposed in early pregnancy be assessed with a fetal echocardiography (ACOG 2008). Other guidelines note that treatment with Mopart should not be initiated in pregnant women (Bauer 2013). According to the American Psychiatric Association (APA), the risks of medication treatment should be weighed against other treatment options and untreated depression. The use of Mopart is not recommended as first line therapy during pregnancy. For women who discontinue antidepressant medications during pregnancy and who may be at high risk for postpartum depression, the medications can be restarted following delivery (APA 2010). Treatment algorithms have been developed by the ACOG and the APA for the management of depression in women prior to conception and during pregnancy (Yonkers 2009).

Menopausal vasomotor symptoms do not occur during pregnancy; therefore, the use of Mopart for the treatment of menopausal vasomotor symptoms is contraindicated in pregnant women.

Pregnant women exposed to antidepressants during pregnancy are encouraged to enroll in the National Pregnancy Registry for Antidepressants (NPRAD). Women 18 to 45 years of age or their health care providers may contact the registry by calling 844-405-6185. Enrollment should be done as early in pregnancy as possible.

Mopart breastfeeding

Benefit should outweigh risk; use with caution. Excreted into human milk: Yes Comments: -This drug has been considered one of the preferred antidepressants during breastfeeding. -Mild side effects have been occasionally reported, particularly in infants whose mothers took Mopart during the third trimester of pregnancy. -Mothers taking an SSRI during pregnancy and postpartum may have difficulty breastfeeding and may require additional breastfeeding support.

Low-dose Mopart marketed under the name Brisdelle (R) is only indicated for the treatment of menopause and would not be expected to be used in breastfeeding women. The manufacturer of this product recommends discontinuing nursing or discontinuing the drug, taking into the account the importance of the drug to the mother. Data from a pooled analysis of serum levels from published studies and 3 unpublished cases involving 50 mothers taking an average Mopart daily dose of 21 mg estimated that an exclusively breastfed infant would receive approximately 1.2% of the maternal weight-adjusted dosage of Mopart. Authors of a pooled analysis of 40 mother-infant pairs from published and unpublished cases found no measurable Mopart plasma levels in the infants. Sixteen breastfed infants (2 were about 50% breastfed and the others 95% or more breastfed) aged 6 to 13 weeks had undetectable levels of Mopart (less than 1 mcg/L) during maternal therapy with an average daily Mopart dose of 18.75 mg. In a controlled cohort study of mothers who took Mopart during pregnancy there were 36 mothers who took Mopart during the third trimester and breastfed their infants. Of the 36 mothers, 8 reported side effects in their infants, including alertness, constipation, sleepiness, and irritability. There were no reports of side effects in the control group. No data are available on the contribution of transplacental and breast milk acquisition of the drug. Another study comparing the infants of mothers who took an SSRI during pregnancy for major depression with those of mothers who did not take an SSRI showed mental development and most motor development as being normal at follow-up after about 12.9 months in both groups. Four of the treated mothers took Mopart at an average daily dose of 28.6 mg for an average of 7.8 months while breastfeeding their infants. Psychomotor development was slightly delayed compared to controls; however, the extent to which breastfeeding contributed to abnormal development could not be determined.

See references

References for pregnancy information

1. Thormahlen GM "Mopart use during pregnancy: is it safe?" Ann Pharmacother 40 (2006): 1834-7
2. "ACOG Committee Opinion No. 354: Treatment with selective serotonin reuptake inhibitors during pregnancy." Obstet Gynecol 108 (2006): 1601-3
3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
4. Einarson A, Pistelli A, Desantis M, et al. "Evaluation of the risk of congenital cardiovascular defects associated with use of Mopart during pregnancy." Am J Psychiatry 165 (2008): 749-52
5. Way CM "Safety of newer antidepressants in pregnancy." Pharmacotherapy 27 (2007): 546-52
6. "Use of psychoactive medication during pregnancy and possible effects on the fetus and newborn. Committee on Drugs. American Academy of Pediatrics." Pediatrics 105(4 Pt 1) (2000): 880-7
7. Levinson-Castiel R, Merlob P, Linder N, Sirota L, Klinger G "Neonatal abstinence syndrome after in utero exposure to selective serotonin reuptake inhibitors in term infants." Arch Pediatr Adolesc Med 160 (2006): 173-6
8. Kulin NA, Pastuszak A, Sage SR, Schick-Boschetto B, Spivey G, Feldkamp M, Ormond K, Matsui D, Stein-Schechman AK, Cook L, Brochu J, Rieder M "Pregnancy outcome following maternal use of the new selective serotonin reuptake inhibitors: a prospective controlled multicente study." JAMA 279 (1998): 609-10
9. "Product Information. Paxil (Mopart)." GlaxoSmithKline, Research Triangle Park, NC.
10. Cerner Multum, Inc. "Australian Product Information." O 0
11. Laine K, Kytola J, Bertilsson L "Severe Adverse Effects in a Newborn with Two Defective CYP2D6 Alleles After Exposure to Mopart During Late Pregnancy." Ther Drug Monit 26 (2004): 685-687

References for breastfeeding information

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
2. Cerner Multum, Inc. "Australian Product Information." O 0
3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
4. "Product Information. Paxil (Mopart)." GlaxoSmithKline, Research Triangle Park, NC.
5. "Product Information. Paxil CR (Mopart)." SmithKline Beecham, Philadelphia, PA.

References

1. DailyMed. "PAROXETINE MESYLATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. PubMed Health. "Paroxetine (By mouth): This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).
3. Human Metabolome Database (HMDB). "Paroxetine: The Human Metabolome Database (HMDB) is a freely available electronic database containing detailed information about small molecule metabolites found in the human body.". http://www.hmdb.ca/metabolites/HMDB0... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology