Borstvoeding en schildklierremmers

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Borstvoeding en schildklierremmers

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Omdat vragen over borstvoeding en het gebruik van strumazol of PTU geregeld gesteld worden op schildklierfora.

2017 Guidelines of the American Thyroid Association for the Diagnosis and Management of Thyroid Disease During Pregnancy and the Postpartum


Question 92: Are ATDs (PTU, MMI) transferred into breast milk, and what are the clinical consequences to the breastfed infant?

Both PTU and MMI can be detected in the breast milk of treated hyperthyroid women. This finding raised initial concern that consumption of these medications could prove detrimental to the health of the breastfeeding infant. However, studies first performed using PTU confirmed that only a very small amount of the drug is transferred from maternal serum into breast milk. In a study of nine women given 200 mg PTU orally, milk PTU concentration was measured for 4 hours thereafter and only 0.007%–0.077% of the ingested dose was detected. The authors calculated that a lactating mother consuming PTU 200 mg three times daily would transmit only 149 μg (0.149 mg) of PTU daily to her infant (538). This is well below a therapeutic dose and deemed to pose no risk to the breastfeeding infant. Separate studies confirm normal thyroid function in breastfed infants of mothers consuming PTU (539,540). In these studies, two infants were found to have an elevated TSH within 1 week of birth, however, these values normalized thereafter despite continued breastfeeding. This suggests the cause of neonatal hypothyroidism in these infants was transplacental passage of PTU before birth, as opposed to any adverse effect of PTU transferred via breast milk. The remaining children who consumed breast milk expressed from mothers taking PTU had normal thyroid function.

Studies of MMI or CM, confirm a 4- to 7-fold higher proportion of the medication transferred into maternal milk in comparison to PTU. Approximately 0.1%–0.2% of an orally administered MMI/CM dose is excreted into breast milk (541,542). Johansen and colleagues (541) calculated that a single 40 mg dose of MMI could result in delivery of 70 μg (0.07 mg) to the breastfeeding infant. Several studies have separately investigated the effect of maternally ingested MMI or CM upon the thyroid status of the breastfeeding infant (543–545). Virtually all have documented normal neonatal thyroid function. Furthermore, several women overtreated with MMI/CM were found to have elevated TSH concentrations (TSH 19–102 mU/L). Even in these situations, normal neonatal thyroid function was nonetheless confirmed in breastfeeding infants.

The largest study investigating the effects of maternal MMI consumption during lactation was performed by Azizi and colleagues (545). Importantly, this study assessed both neonatal thyroid function in the breastfeeding offspring, but also intellectual development and physical growth in a subset of infants. Verbal and performance IQ scores were measured in 14 children who breastfed from MMI-treated mothers, with comparison to 17 control children. Testing was performed between 48 and 74 months of age. No difference was detected in the IQ or physical development of the breastfeeding children compared to the control children (543).

Together, these data have led experts to confirm the safety of low to moderate doses of both PTU and MMI/CM in breastfeeding infants. However, given the relatively small size of the studied population, maximal daily doses of 20 mg MMI or 450 mg PTU are advised (352).

Question 93: What is the approach to the medical treatment of maternal hyperthyroidism in lactating women?

■ RECOMMENDATION 78

Excepting treatment decisions specifically made on the grounds of improving lactation (discussed above), the decision to treat hyperthyroidism in lactating women should be guided by the same principles applied to nonlactating women.

 Strong recommendation, low-quality evidence.

Question 94: When medical treatment of maternal hyperthyroidism is indicated, what medications should be administered?

■ RECOMMENDATION 79

 When antithyroid medication is indicated for women who are lactating, both MMI (up to maximal dose of 20 mg/d) and PTU (up to maximal dose of 450 mg/d) can be administered. Given a small, but detectable amount of both PTU and MMI transferred into breast milk, the lowest effective does of MMI/CM or PTU should always be administered.

 Strong recommendation, moderate-quality evidence.

Question 95: How should breastfeeding children of mothers who are treated with antithyroid medications be monitored?

■ RECOMMENDATION 80

 Breastfed children of women who are treated with ATDs should be monitored for appropriate growth and development during routine pediatric health and wellness evaluations. Routine assessment of serum thyroid function in the child is not recommended.

 Weak recommendation, moderate-quality evidence.
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Re: Borstvoeding en schildklierremmers

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Antithyroid drugs during breastfeeding
Hudzik B, Zubelewicz-Szkodzinska B

Abstract

Antithyroid drugs (ATDs) are widely used for the treatment of Graves' disease (GD) in the general population. Over the past decade, there has been an increasing awareness that several disturbances of thyroid function may occur in mothers after delivery which may be more prevalent than previously appreciated. Exacerbation of immune reactions occurs 3-12 month following delivery. Management of hyperthyroidism during lactation requires special considerations and should be implemented to prevent any adverse outcomes in mother and neonate. Continuation of breastfeeding is safe and should be encouraged in hyperthyroid mothers taking ATDs, whether these are ATDs being continued after gestation or indeed ATD treatment initiated in the postpartum period. Given PTU hepatotoxicity concerns, experts currently recommend using low-to-moderate MMI doses as a first-line therapy in lactating mothers. PTU should be reserved only as a second-line agent for cases of severe hyperthyroidism (thyroid storm) and allergic reactions to previous MMI treatment.

ATD should be administered in divided doses immediately following each feeding.
Evaluation of thyroid function tests is advisable at least 3-4 weeks after the initiation of breastfeeding.
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Breastfeeding and Antithyroid Drugs: A View from Within
Karras S, Krassas G.E.

Keywords: Antithyroid drugs Breastfeeding Graves’ disease Hyperthyroidism Propylthiouracil Carbimazole Methimazole
Eur Thyroid J 2012;1:30–33
https://doi.org/10.1159/000336595

Abstract

The aim of this communication is to provide information regarding the use of antithyroid drugs (ATD) during lactation. Three ATD are used today: propylthiouracil (PTU), methimazole (MMI) and carbimazole (CMZ). The latter is a prodrug which is bioactivated to MMI. PTU is transferred in small amounts (0.025%) into milk. These amounts were considered nonsignificant for inducing adverse effects for the suckling infant. The amount of MMI excreted in milk is equal to MMI levels in serum. Due to its lower concentrations in milk, PTU was used for decades as the treatment of choice during breastfeeding. Recent studies have demonstrated that physical development, intelligence scores and thyroid status of children whose mothers had received MMI while breastfeeding were similar to those of healthy children. These new data offered clinicians an alternative drug approach. Several hepatic dysfunction studies have been published so far. Clinical manifestations varied from mild to severe hepatic failure, liver transplantation or death. Most PTU cases were more severe, idiosyncratic and not dose related.

We recommend that PTU should not be prescribed for thyrotoxicosis during lactation.
MMI should be used instead, in doses up to 30 mg/day, while PTU should be used in special cases for a restricted time period.
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Re: Borstvoeding en schildklierremmers

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NIV-Richtlijn Schildklierfunctiestoornissen
Revisie 2012 | pagina 199

In de literatuur zijn geen aanwijzingen te vinden dat gebruik van lage doseringen thyreostatica (PTU < 300 mg per dag en thiamazol < 20 mg per dag) tijdens het geven van borstvoeding schadelijk is voor de pasgeborene. Tijdens het geven van borstvoeding wordt thiamazol aanbevolen (max 20 mg). Een behandeling met radioactief jodium mag niet gegeven worden in deze periode.
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Bijwerkingencentrum Lareb

Propylthiouracil gaat in kleine hoeveelheden over in de moedermelk. Er zijn geen mel­dingen van effecten op de schildklierfunctie van de zuigeling. Carbimazol en thiamazol gaan in grotere hoeveelheden over in de moedermelk. Tot nu toe zijn er geen meldin­gen van effecten op de schildklierfunctie van de zuigeling. Er zijn geen aanwijzingen dat gebruik van lage doseringen thyreostatica (propylthiouracil < 300 mg/dag en thiamazol < 20 mg/dag) tijdens de borstvoeding schadelijk is voor de zuigeling. Overwogen kan worden om de schildklierfunctie van de zuigeling te controleren, zeker als hoge doserin­gen worden toegepast.
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Re: Borstvoeding en schildklierremmers

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Farmacotherapeutisch Kompas

Propylthiouracil Tabletten - Lactatie
Overgang in de moedermelk: In geringe mate.

Farmacologisch effect: Theoretisch is er een kans op hypothyreoïdie bij de zuigeling.
Er zijn echter bij een dosering van < 300 mg/dag geen meldingen van effecten op de schildklierfunctie van de zuigeling.

Advies: Kan volgens voorschrift worden gebruikt, bij voorkeur in lage dosering.
Overweeg om de schildklierfunctie van de zuigeling te controleren, zeker als hoge doseringen worden toegepast.
Strumazol Tabletten - Lactatie
Overgang in de moedermelk: ja, de concentratie is dezelfde als die in het serum van de moeder.

Farmacologisch effect: Theoretisch is er een kans op hypothyreoïdie bij de zuigeling.
Er zijn echter bij een dosering van < 20 mg/dag geen meldingen van effecten op de schildklierfunctie van de zuigeling.

Advies: Kan volgens voorschrift worden gebruikt, bij voorkeur in lage dosering.
Overweeg om de schildklierfunctie van de zuigeling te controleren, zeker als hoge doseringen worden toegepast.
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rosan
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Re: Borstvoeding en schildklierremmers

Bericht door rosan »

interessant. Hebben ze in het onderzoek ook gekeken naar leverwaardes?
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laura
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Re: Borstvoeding en schildklierremmers

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rosan schreef: 29 mar 2018, 09:39 interessant. Hebben ze in het onderzoek ook gekeken naar leverwaardes?
hoi Rosan,

Rekening is gehouden met mogelijke bijwerkingen van PTU.
Vandaar dat strumazol de voorkeur heeft.
Wat niet wil zeggen dat PTU niet kan.
laura

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Drugs and Lactation Database (LactMed) - Methimazole (strumazol, thiamazol)

Drugs Levels and Effects

Summary of Use during Lactation
Maternal methimazole therapy does not affect thyroid function or intellectual development in breastfed infants with doses up to 20 mg daily. Taking methimazole right after nursing and waiting for 3 to 4 hours before nursing again should minimize the infant dosage. No cases of thyroid function alteration have been reported among infants exposed to methimazole via breastmilk.

The American Thyroid Association recommends only monitoring infants for appropriate growth and development during routine pediatric health and wellness evaluations and routine assessment of serum thyroid function in the child is not recommended.[1] Rare idiosyncratic reactions (e.g., agranulocytosis) might occur, and the infant should be watched for signs of infection. Monitoring of the infant's complete blood count and differential is advisable if there is a suspicion of a drug-induced blood dyscrasia.

Drug Levels

Maternal Levels. One mother (time postpartum not stated) taking 2.5 mg of methimazole every 12 hours orally had a peak milk level of 67 mcg/L at about 2 hours after nursing.[2]

Four lactating women who were 3 to 6 months postpartum received a single dose of methimazole 40 mg orally. Milk levels paralleled serum levels closely at about the same concentration over the next 8 hours during which time an average of 70 mcg of methimazole was excreted into breastmilk. The average peak level of 720 mcg/L occurred at 1 hour after the dose.[3]

Six lactating women were given a single oral dose of methimazole 15 mg. Peak milk levels of 320 mcg/L occurred 2 hours after the dose. At 12 hours after the dose, milk levels were 30 mcg/L. The half-life of the drug in milk averaged 4.2 hours.[4]

Infant Levels. Ten women taking methimazole nursed their infants 2 hours after taking a 10 mg dose of methimazole orally (approximately the time of the peak milk level). Infant serum levels were measured 2 hours after nursing. Seven of the 10 infants had undetectable (<30 mcg/L) serum levels of methimazole, In the other 3, serum levels were 30, 34 and 35 mcg/L.[5][6]

Effects in Breastfed Infants

Five mothers taking methimazole 5 to 15 mg daily at 6 pm breastfed their infants during the day using expressed milk or formula at night. Thyroid function test remained normal during 90 days of study and none of the infants showed any clinical signs of hypothyroidism and methimazole was undetectable (<10 mcg/L) in the infants' serum.[4]

Twelve mothers taking methimazole 5 mg daily breastfed their infants from the time of delivery. Another 17 women were given methimazole 5 mg twice daily beginning 2 to 8 months postpartum and allowed to breastfeed their infants exclusively with supplementation given to those over 6 months of age. A third group of 6 mothers took methimazole 10 mg twice daily. All infants were normal clinically and had normal thyroid function tests when measured 2 to 4 weeks after the start of therapy.[7] (Note: this paper is apparently the full publication of a previous report in abstract form.[8])

The breastfed infants of 16 mothers who became hypothyroid during methimazole therapy were studied 5 times between birth and 12 months of age in comparison to a control group of 18 breastfed infants whose mothers did not become hypothyroid during methimazole therapy and a group of 24 infants of normal mothers. There were no differences in thyroid function tests of the infants from the 3 groups.[6]

Fifty-one infants of mothers who took methimazole during pregnancy and continued during lactation with a dose of 5 mg daily and 88 infants of mothers who took the drug starting 2 to 8 months postpartum were studied. All infants had normal thyroid function tests for up to a year of maternal therapy with doses of 5 to 20 mg daily of methimazole. Fourteen children who had been breastfed as infants were compared to a control group of children whose mothers did not take methimazole. Performance on IQ tests did not differ between the two groups.[9] Forty-two of these children were restudied after 4 years of age and found to have IQ scores equal to children under the age of 6 in a matched control group.[10]

References

1. Alexander EK, Pearce EN, Brent GA et al. 2016 Guidelines of the American Thyroid Association for the Diagnosis and Management of Thyroid Disease during Pregnancy and the Postpartum. Thyroid. 2017;27:315-89. [PubMed]
2. Tegler L, Lindstrom B. Antithyroid drugs in milk. Lancet. 1980;2:591. Letter. [PubMed]
3. Cooper DS, Bode HH, Nath B et al. Methimazole pharmacology in man: studies using a newly developed radioimmunoassay for methimazole. J Clin Endocrinol Metab. 1984;58:473-9. [PubMed]
4. Abe Y, Sato H, Sakai H et al. Antithyroid treatment of maternal hyperthyroidism during lactation. Thyroid. 1995;5 (Suppl 1):S108. Abstract. DOI: 10.1089/thy.1995.5.ii. [CrossRef]
5. Azizi F, Heydayati M. Thyroid function in breast-fed infants whose mothers take high doses of methimazole. J Endocrinol Invest. 2002;25:493-6. [PubMed]
6. Azizi F. Thyroid function in breast-fed infants is not affected by methimazole-induced maternal hypothyroidism: results of a retrospective study. J Endocrinol Invest. 2003;26:301-4. [PubMed]
7. Azizi F. Effect of methimazole treatment of maternal thyrotoxicosis on thyroid function in breast-feeding infants. J Pediatr. 1996;128:855-8. [PubMed]
8. Azizi F. Methimazole treatment of maternal hyperthyroidism during lactation. Thyroid. 1995;5 (Suppl 1):S108. Abstract. DOI: 10.1089/thy.1995.5.ii. [CrossRef]
9. Azizi F, Khoshniat M, Bahrainian M et al. Thyroid function and intellectual development of infants nursed by mothers taking methimazole. J Clin Endocrinol Metab. 2000;85:3233-8. [PubMed]
10. Azizi F, Bahrainian M, Khamseh ME et al. Intellectual development and thyroid function in children who were breast-fed by thyrotoxic mothers taking methimazole. J Pediatr Endocrinol Metab. 2003;16:1239-43. [PubMed]
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Drugs and Lactation Database (LactMed) - Propylthiouracil (PTU)

Drug Levels and Effects

Summary of Use during Lactation

Propylthiouracil (PTU) had been considered the antithyroid drug of choice during lactation;[1][2] however, findings that the rates of liver injury higher with PTU than with methimazole has altered this judgement.[3] Some experts now recommend that methimazole should be considered the antithyroid drug of choice in nursing mothers.[4][5] No cases of PTU-induced liver damage have been reported in breastfed infants and it is unknown if the small amounts of the drug in breastmilk can cause liver damage. The drug or breastfeeding should be discontinued if liver toxicity is suspected. Dosages of PTU should be limited to 450 mg daily during breastfeeding.[6]

The American Thyroid Association recommends only monitoring infants for appropriate growth and development during routine pediatric health and wellness evaluations and routine assessment of serum thyroid function in the child is not recommended.[6] Rare idiosyncratic reactions (e.g., agranulocytosis) might occur, and the infant should be watched for signs of infection. Monitoring of the infant's complete blood count and differential is advisable if there is a suspicion of a drug-induced blood dyscrasia.

Drug Levels

Maternal Levels. A woman (time postpartum not stated) given a single dose of 100 mg of propylthiouracil (PTU) excreted a total of 0.077% of the dose in her breastmilk in 24 hours.[7]

After a single oral dose of 400 mg of propylthiouracil (PTU) in 9 women who were 1 to 9 months postpartum, peak milk levels averaging 0.7 mg/L were reached 1.5 hours after the dose. The authors estimated that the infant of a mother taking 200 mg 3 times a day would receive no more than 462 mcg daily or a maximum of 0.025% (range 0.07 to 0.077%) of the maternal dosage.[8]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

A mother was taking oral propylthiouracil 100 mg daily during pregnancy and 125 mg daily after delivery. In her infant, serum thyroxine (T4) concentration dropped slightly below the lower limit of normal on day 4 of life, but both T4 and thyrotropin (TSH) concentrations were normal on day 19 with continued maternal PTU therapy.[9] The drop in T4 was possibly due to propylthiouracil in breastmilk, but more likely from PTU received transplacentally.

An infant whose mother was taking propylthiouracil 200 to 300 mg daily was followed for 5 months and found to have normal thyroid function tests.[8]

A mother took PTU in a starting dose of 100 mg 3 times daily that was tapered to 50 mg twice daily over a period of 6 months. Her breastfed infant had normal thyroid function tests during this period at the ages of 9 to 13 months of age.[10]

Eight mothers taking PTU during pregnancy and doses of 50 to 300 mg daily after delivery exclusively or nearly exclusively breastfed their infants. The infants all had slightly low free T4 levels at birth and TSH levels were above normal in 7 of the 8, indicating that they had been affected by PTU in utero. All of their infants had normal free T4 and TSH levels when measured between 18 days and 8 months of age and none had any adverse effects reported from PTU in milk.[11]

The mothers of 11 fully breastfed infants were taking 300 to 750 mg daily of PTU starting at various times between delivery and 11 months postpartum. One infant had slightly elevated TSH level at 19 weeks of age when his mother was taking PTU 450 mg daily. Two other infants had elevated TSH levels at birth. TSH normalized in both infants with maternal PTU doses of 600 mg daily in one and a dose starting at 300 mg daily at term and increasing to 600 mg daily in the other.[12]

Two other infants were reported to be hypothyroid at birth, but to have normal thyroid function at 1 month of age despite maternal PTU therapy during breastfeeding.[13]

References
1. Cooper DS. Antithyroid drugs: to breast-feed or not to breast-feed. Am J Obstet Gynecol. 1987;157:234-5. [PubMed]
2. Mandel SJ, Cooper DS. The use of antithyroid drugs in pregnancy and lactation. J Clin Endocrinol Metab. 2001;86:2354-9. [PubMed]
3. U.S. Food and Drug Administration. Propylthiouracil (PTU)-induced liver failure. FDA Alert. June 3, 2009. http://www​.fda.gov/Drugs​/DrugSafety/P ... 162701.htm.
4. Karras S, Tzotzas T, Krassas GE. Antithyroid drugs used in the treatment of hyperthyroidism during breast feeding. An update and new perspectives. Hormones (Athens). 2009;8:254-7. [PubMed]
5. Hudzik B, Zubelewicz-Szkodzinska B. Anti-thyroid drugs during breastfeeding. Clin Endocrinol (Oxf). 2016;85:827-30. [PubMed]
6. Alexander EK, Pearce EN, Brent GA et al. 2016 Guidelines of the American Thyroid Association for the Diagnosis and Management of Thyroid Disease during Pregnancy and the Postpartum. Thyroid. 2017;27:315-89. [PubMed]
7. Low LC, Lang J, Alexander WD. Excretion of carbimazole and propylthiouracil in breast milk. Lancet. 1979;314:1011. Letter. [PubMed]
8. Kampmann JP, Johansen K, Hansen JM et al. Propylthiouracil in human milk: revision of a dogma. Lancet. 1980;1:736-7. [PubMed]
9. Lamberg BA, Ikonen E, Osterlund K et al. Antithyroid treatment of maternal hyperthroidism during lactation. Clin Endocrinol (Oxf). 1984;21:81-7. [PubMed]
10. McDougall IR, Bayer MF. Should a woman taking propylthiouracil breast-feed? Clin Nucl Med. 1986;11:249-50. [PubMed]
11. Momotani N, Yamashita R, Yoshimoto M et al. Recovery from foetal hypothyroidism: evidence for the safety of breast-feeding while taking propylthiouracil. Clin Endocrinol (Oxf). 1989;31(5):591-5. [PubMed]
12. Momotani N, Yamashita R, Makino F et al. Thyroid function in wholly breast-feeding infants whose mothers take high doses of propylthiouracil. Clin Endocrinol (Oxf). 2000;53(2):177-81. [PubMed]
13. Lee A, Moretti ME, Collantes A et al. Choice of breastfeeding and physicians' advice: a cohort study of women receiving propylthiouracil. Pediatrics. 2000;106(1 pt. 1):27-30. [PubMed]
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