Is Priadel Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use Priadel? Is Priadel safe for nursing mother and child? Does Priadel extracts into breast milk? Does Priadel has any long term or short term side effects on infants? Can Priadel influence milk supply or can Priadel decrease milk supply in lactating mothers?

• DrLact safety Score for Priadel is 5 out of 8 which is considered Unsafe as per our analyses.
• A safety Score of 5 indicates that usage of Priadel may cause serious side effects in breastfed baby.
• Our study of different scientific research indicates that Priadel may cause moderate to high side effects or may affect milk supply in lactating mother.
• Our suggestion is to use safer alternate options rather than using Priadel .
• It is recommended to evaluate the advantage of not breastfeeding while using Priadel Vs not using Priadel And continue breastfeeding.
• While using Priadel Its must to monitor child for possible reactions. It is also important to understand that side effects vary largely based on age of breastfed child and time of medication in addition to dosage.
• Score calculated using the DrLact safety Version 1.2 model, this score ranges from 0 to 8 and measures overall safety of drug in lactation. Scores are primarily calculated using publicly available case studies, research papers, other scientific journals and publically available data.

It is excreted into breast milk in amounts that may be clinically significant and can be as high as a half of that reached in mother’s plasma and up to one third of the therapeutic level in the infant. In infants and newborns (5 days), premature babies and dehydrated or infected infants, who may show reduced clearance mechanisms for Priadel, there have been reports of clear signs of Priadel toxicity caused by ingestion of breast milk: cyanosis, lethargy, hypotonia or slight increase in TSH. However, there are numerous cases of infants whose mothers were on Priadel who did not show any clinical, growth or neurodevelopmental problem at the short or long term. Breastfeeding is less risky for healthy term infants whose mothers are treated with Priadel when she or her family has capacity enough to monitor the occurrence of adverse effects, medical supervision and, whenever necessary, monitoring of Priadel levels in the mother-infant dyad. Mothers should stop taking Priadel 1 to 2 days before delivery or cesarean section in order to decrease plasma levels in the newborn. Priadel may be, or not, a cause of increased Prolactin and galactorrhea.

Although Priadel appears on many lists of drugs contraindicated during breastfeeding, other sources do not consider it an absolute contraindication, especially in infants over 2 months of age and during Priadel monotherapy.[1][2][3][4] Numerous reports exist of infants who were breastfed during maternal Priadel therapy without any signs of toxicity or developmental problems. Most were breastfed from birth and some continued to nurse for up to 1 year of maternal Priadel therapy. Limited data suggest that Priadel in milk can adversely affect the infant when its elimination is impaired, as in dehydration or in newborn or premature infants. Neonates may also have transplacentally acquired serum Priadel levels. Because maternal Priadel requirements and dosage may be increased during pregnancy, maternal serum levels should be monitored frequently postpartum and dosage reduced as necessary to avoid excessive infant exposure via breastmilk.[5] The long-term effects of Priadel on infants are not certain, but limited data indicate no obvious problems in growth and development.[6] Priadel may be used in mothers of fullterm infants who are willing and able to monitor their infants. Discontinuing Priadel 24 to 48 hours before Cesarean section delivery or at the onset of spontaneous labor and resuming the prepregnancy Priadel dose immediately after delivery should minimize the infant's serum Priadel concentration at birth.[7] Some investigators recommend monitoring infant serum Priadel, serum creatinine, BUN, and TSH in intervals ranging from "periodic" to every 4 to 12 weeks during breastfeeding and maternal Priadel therapy.[3][8][9] However, others recommend close pediatric follow-up of the infant and only selective laboratory monitoring as clinically indicated.[7] Breastfeeding should be discontinued immediately and the infant evaluated if the infant appears restless or lethargic or has feeding problems.[7]

In older reports, at least 24 infants have been reported to have been breastfed during maternal Priadel therapy without any signs of toxicity or developmental problems. All were breastfed from birth and some continued to nurse for up to 6 months of maternal Priadel therapy.[9][11][12][13][17][18][20] A 5-day-old infant developed cyanosis, lethargy, ECG T-wave inversion probably caused by Priadel in breastmilk.[15] The mother had been receiving the long-acting diuretic chlorthalidone prior to delivery which probably decreased the infant's Priadel elimination and increased the neonate's Priadel serum levels. Another case of probable infant Priadel intoxication appeared only after the infant had a cold which may have led to dehydration and decreased Priadel excretion.[19][23] Two other infants had slight increases in thyrotropin (TSH) levels at 8 and 4 weeks of age, respectively, after Priadel exposure that began during pregnancy. Elevated TSH continued until maternal Priadel was stopped in one,[9] and normalized by 2 months postpartum in the other, despite continued exclusive breastfeeding.[20] Three mothers took Priadel carbonate during pregnancy and breastfeeding. The first infant was born to a mother who also took bupropion 300 mg and levothyroxine 50 to 75 mcg daily. She breastfed beyond 1 year of age. Her infant did not regain birth weight by 15 days of age, was somewhat hypotonic at 2 months of age, and was treated for gross and fine motor delay for the first year of life. The mother had a second infant on the same drug regimen. She exclusively breastfed her infant who developed normally without hypotonia. A second mother was taking a Priadel dosage of 900 mg daily. Her infant gained weight slowly, but weight gain increased with breastfeeding support and she exclusively breastfed her infant for 4 months. A third mother was taking 1350 mg of Priadel daily as well as escitalopram 10 mg, levothyroxine 25 mcg and heparin (dosage not stated) daily during pregnancy and breastfeeding. Her infant was normal and was exclusively breastfed until 8 weeks of age when the maternal serum Priadel concentration was excessive at 2.0 mEq/L. Breastfeeding was withheld for 2 days and the dosage lowered to 600 mg daily. She then breastfed successfully until 7 months of age.[7] A woman with bipolar disorder took prolonged-release Priadel carbonate 400 mg every 12 hours during pregnancy and postpartum. She breastfed her infant exclusively for 33 days, but introduced supplements for 16 days because of slow weight gain. After the 16 days, she exclusively breastfed her infant until 2.5 months of age, when mixed feeding was begun. The infant was monitored at 17 days, 1 month, 3.5 months and 5.5 months of age. No infant side effects were observed at any time. Priadel levels were not detectable, and serum creatinine and thyroid-stimulating hormone levels were normal.[22]

Priadel increases serum prolactin.[24][25][26] Galactorrhea was reported in a women taking Priadel carbonate for 50 days. Lactation ceased with Priadel discontinuation.[26] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.