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Motherisk Update, Exams of Nursing

Washington State University (WSU or Wazzu)Nursing

Considering the minimal exposure of a nursing infant to the drugs through breast milk, mater- nal use of loratadine, desloratadine, or fexofenadine in a.

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Vol 56: may • mai 2010 Canadian Family Physician • Le Médecin de famille canadien 427
Motherisk Update
Safety of antihistamines during
pregnancy and lactation
Miranda So RPh Pina Bozzo Miho Inoue MD Adrienne Einarson RN
Common symptoms of allergic rhinitis include nasal
congestion, discharge, and itching, as well as eye
involvement such as conjunctival redness, swelling,
and excessive lacrimation. The symptoms are typically
triggered by airborne allergens (eg, pollens from trees,
grasses, weeds); however, household allergens such
as dust mites or animal dander are also common trig-
gers.1 Allergic diseases are estimated to affect 20% to
30% of women of childbearing age, making them the
most common medical conditions to complicate preg-
nancy.2 Furthermore, during pregnancy, up to 10% to
30% of women with pre-existing allergic rhinitis have
reported increased symptoms.1 Possible explanations
include increased circulating blood volume, nasal vas-
cular engorgement, and increased secretions from nasal
mucosa due to hormonal influences.1
First-generation antihistamines
Antihistamines targeting histamine–type 1 (H1) receptors
are commonly used to treat allergic rhinitis. Examples
of first-generation antihistamines are brompheniramine,
chlorpheniramine, dimenhydrinate, diphenhydramine,
doxylamine, hydroxyzine, and pheniramine. Most—
with the exception of doxylamine and dimenhydrinate,
both used for the treatment of nausea and vomiting,
and hydroxyzine (prescription-only)—are commonly
found in over-the-counter allergy and cold medications.
None of the medications in this class of drugs has been
reported to increase fetal risk when used at any time
during pregnancy.2 Epidemiologic data support safety in
early pregnancy,3 with a meta-analysis involving more
than 200 000 participants concluding that there was no
increase in any type of congenital malformation.4
Second-generation antihistamines
At present, medications from this class of drugs are pre-
ferred because they do not cause central nervous sys-
tem adverse effects (eg, drowsiness) and because they
are available without prescription. Examples of second-
generation antihistamines are cetirizine, desloratadine,
fexofenadine, and loratadine.
Cetirizine. Cetirizine is the active metabolite of hydroxy-
zine. A small prospective, comparative study conducted
by Motherisk following 120 women exposed to hydroxy-
zine and 39 to cetirizine (37 in first trimester) did not find
differences in pregnancy outcomes between the exposed
and comparison groups.5 Pregnancy outcomes from the
ABSTRACT
QUESTION Many of my pregnant and breastfeeding patients suffer from allergies and frequently ask me about
the safety of antihistamines during pregnancy and breastfeeding. Should I advise them to use the older sedating
medications? I have heard that they might be safer than the newer nonsedating class of drugs. Or have the
newer ones been studied as well?
ANSWER First-generation antihistamines are considered safe to use during pregnancy. There are relatively
fewer data on the nonsedating second-generation antihistamines; however, published studies are reassuring.
All antihistamines are considered safe to use during breastfeeding, as minimal amounts are excreted in the
breast milk and would not cause any adverse effects on a breastfeeding infant.
RÉSUMÉ
QUESTION Beaucoup de mes patientes enceintes ou qui allaitent souffrent d’allergies et me demandent souvent
des questions à propos de l’innocuité des antihistaminiques durant la grossesse et l’allaitement. Devrais-je leur
conseiller d’utiliser les plus anciens sédatifs? J’ai entendu dire qu’ils étaient peut-être plus sécuritaires que les plus
récentes classes de médicaments non sédatifs, à moins que les plus récents produits aient aussi fait l’objet d’études.
RÉPONSE L’utilisation des antihistaminiques de la première génération est considérée sécuritaire pendant
la grossesse. Il y a relativement moins de données sur les antihistaminiques non sédatifs de la deuxième
génération; par ailleurs, les études publiées sont rassurantes. Tous les antihistaminiques sont considérés
sécuritaires durant l’allaitement, étant donné les quantités minimes passant dans le lait maternel, qui ne
devraient pas causer d’effets indésirables chez le nourrisson allaité.
pf3

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Vol 56: may • mai 2010 Canadian Family Physician • Le Médecin de famille canadien 427

Safety of antihistamines during

pregnancy and lactation

Miranda So RPh Pina Bozzo Miho Inoue MD Adrienne Einarson RN

C

ommon symptoms of allergic rhinitis include nasal congestion, discharge, and itching, as well as eye involvement such as conjunctival redness, swelling, and excessive lacrimation. The symptoms are typically triggered by airborne allergens (eg, pollens from trees, grasses, weeds); however, household allergens such as dust mites or animal dander are also common trig- gers. 1 Allergic diseases are estimated to affect 20% to 30% of women of childbearing age, making them the most common medical conditions to complicate preg- nancy. 2 Furthermore, during pregnancy, up to 10% to 30% of women with pre-existing allergic rhinitis have reported increased symptoms. 1 Possible explanations include increased circulating blood volume, nasal vas- cular engorgement, and increased secretions from nasal mucosa due to hormonal influences.^1

First-generation antihistamines Antihistamines targeting histamine–type 1 (H 1 ) receptors are commonly used to treat allergic rhinitis. Examples of first-generation antihistamines are brompheniramine, chlorpheniramine, dimenhydrinate, diphenhydramine, doxylamine, hydroxyzine, and pheniramine. Most— with the exception of doxylamine and dimenhydrinate,

both used for the treatment of nausea and vomiting, and hydroxyzine (prescription-only)—are commonly found in over-the-counter allergy and cold medications. None of the medications in this class of drugs has been reported to increase fetal risk when used at any time during pregnancy. 2 Epidemiologic data support safety in early pregnancy, 3 with a meta-analysis involving more than 200 000 participants concluding that there was no increase in any type of congenital malformation.^4

Second-generation antihistamines At present, medications from this class of drugs are pre- ferred because they do not cause central nervous sys- tem adverse effects (eg, drowsiness) and because they are available without prescription. Examples of second- generation antihistamines are cetirizine, desloratadine, fexofenadine, and loratadine.

Cetirizine. Cetirizine is the active metabolite of hydroxy- zine. A small prospective, comparative study conducted by Motherisk following 120 women exposed to hydroxy- zine and 39 to cetirizine (37 in first trimester) did not find differences in pregnancy outcomes between the exposed and comparison groups.^5 Pregnancy outcomes from the

ABSTRACT

QUESTION Many of my pregnant and breastfeeding patients suffer from allergies and frequently ask me about

the safety of antihistamines during pregnancy and breastfeeding. Should I advise them to use the older sedating medications? I have heard that they might be safer than the newer nonsedating class of drugs. Or have the newer ones been studied as well?

ANSWER First-generation antihistamines are considered safe to use during pregnancy. There are relatively

fewer data on the nonsedating second-generation antihistamines; however, published studies are reassuring. All antihistamines are considered safe to use during breastfeeding, as minimal amounts are excreted in the breast milk and would not cause any adverse effects on a breastfeeding infant.

RÉSUMÉ

QUESTION Beaucoup de mes patientes enceintes ou qui allaitent souffrent d’allergies et me demandent souvent

des questions à propos de l’innocuité des antihistaminiques durant la grossesse et l’allaitement. Devrais-je leur conseiller d’utiliser les plus anciens sédatifs? J’ai entendu dire qu’ils étaient peut-être plus sécuritaires que les plus récentes classes de médicaments non sédatifs, à moins que les plus récents produits aient aussi fait l’objet d’études.

RÉPONSE L’utilisation des antihistaminiques de la première génération est considérée sécuritaire pendant

la grossesse. Il y a relativement moins de données sur les antihistaminiques non sédatifs de la deuxième génération; par ailleurs, les études publiées sont rassurantes. Tous les antihistaminiques sont considérés sécuritaires durant l’allaitement, étant donné les quantités minimes passant dans le lait maternel, qui ne devraient pas causer d’effets indésirables chez le nourrisson allaité.

428 Canadian Family Physician •^ Le Médecin de famille canadien Vol 56: may • mai 2010

Swedish Medical Birth Registry (1995 to 1999) of 17 766 women exposed to antihistamine drugs, 917 of whom used cetirizine, did not show increased risk of malfor- mations or adverse delivery outcomes compared with the general population. 6 In 2004 another study examin- ing 144 first-trimester exposures to cetirizine confirmed the previous results, with no adverse pregnancy out- comes attributed to the drug.^7 The most recent data were from the Berlin teratogen information service, with 196 women exposed in any trimester (11% in the first trimes- ter), also showing no increased risk of birth defects or other adverse outcomes.^8

Fexofenadine. Fexofenadine is an active metabolite of terfenadine, 9 a second-generation H 1 blocker that is no longer available on the Canadian market owing to clinically significant QT prolongation. Although ani- mal studies failed to show teratogenicity, decreases in pup weight and survival were observed. There are no human data on fexofenadine 9 ; however, limited data from terfenadine did not find an increased risk of major malformations.^3

Loratadine and desloratadine. Desloratadine is a major metabolite of loratadine; therefore, data pertain- ing to safety of loratadine might be extrapolated to des- loratadine. 10 A Swedish registry study involving 292 loratadine-exposed women did not suggest an increased risk of major malformations. 6 A Motherisk study pro- spectively following 161 loratadine-exposed women and an equal number of unexposed controls confirmed the safety of loratadine use in pregnancy. 11 Another study comparing 210 pregnant women exposed to lorata- dine and 267 women exposed to other antihistamines with 929 women in a control group also failed to show an association with loratadine. 12 However, a further analysis from the Swedish registry reported an increased risk of hypospadias, 13 although this association has not been confirmed by the other studies.3,14^ Furthermore, a recent meta-analysis conducted by Motherisk compar- ing 2694 male infants exposed to loratadine in utero with 450 413 unexposed controls also failed to confirm such an association. 15

Antihistamines and breastfeeding Although the data regarding the use of first-generation antihistamines and breastfeeding is limited, only min- imal amounts of these drugs have been reported to be secreted in breast milk. 16,17^ In a telephone follow-up study conducted by Motherisk, 10% of mothers reported irritability and colicky symptoms in their infants exposed to various antihistamines, and drowsiness was reported in 1.6% of infants. None of the reactions required med- ical attention.^18 Therefore, short-term or occasional use of the older generation antihistamines would not be expected to be a concern during breastfeeding.

Among the second-generation H 1 blockers, data on drug concentration in breast milk are available for loratadine, desloratadine, and fexofenadine. The pharmacokinetics of loratadine and its metabolite desloratadine in breast milk were studied in 6 lactat- ing women after a single oral dose of 40 mg of lorata- dine,^19 which is 4 times the current standard therapeutic dose. Assuming the breast milk intake by an infant is 150 mL/kg daily, the maximum infant loratadine-equiv- alent dose based on the highest concentration of lorata- dine and desloratadine in breast milk was estimated to be 7.3 μg/kg daily (ie, 1.1% of the daily dose given to the mother in mg/kg). The pharmacokinetics of fexofena- dine in breast milk were studied in 4 lactating women taking 60 mg of terfenadine every 12 hours. 20 The maxi- mum infant dose of fexofenadine based on the highest concentration of fexofenadine in breast milk would be 9 μg/kg daily (ie, 0.45% of the daily dose given to the mother in mg/kg). Considering the minimal exposure of a nursing infant to the drugs through breast milk, mater- nal use of loratadine, desloratadine, or fexofenadine in a standard therapeutic dose is unlikely to result in adverse effects in nursing infants and is considered to be com- patible with breastfeeding.

Conclusion Although seasonal allergy is not a life-threatening medi- cal condition, it can be extremely troublesome for preg- nant women and breastfeeding mothers. Based on the current body of evidence, which is large, first-generation H 1 blockers are not associated with an increased risk of major malformations or any other adverse fetal effects. Although there is less evidence on second-generation H 1 blockers, they have also not been associated with an increased risk of adverse pregnancy outcomes. In addition, none of the antihistamines is excreted in the breast milk in an appreciable amount so as to have any adverse effects on the breastfeeding infant. Therefore, pregnant and breastfeeding women can be reassured that they can alleviate their symptoms without posing an increased risk to their fetuses or infants. Competing interests None declared References

  1. Incaudo GA, Takach P. The diagnosis and treatment of allergic rhinitis during pregnancy and lactation. Immunol Allergy Clin North Am 2006;26(1):137-54.
  2. Buhimschi CS, Weiner CP. Medications in pregnancy and lactation: part 2. Drugs with minimal or unknown human teratogenic effect. Obstet Gynecol 2009;113(2 Pt 1):417-32.
  3. Gilbert C, Mazzotta P, Loebstein R, Koren G. Fetal safety of drugs used in the treatment of allergic rhinitis: a critical review. Drug Saf 2005;28(8):707-19.
  4. Seto A, Einarson T, Koren G. Pregnancy outcome following first trimester exposure to antihistamines: meta-analysis. Am J Perinatol 1997;14(3):119-24.
  5. Einarson A, Bailey B, Jung G, Spizzirri D, Baillie M, Koren G. Prospective con- trolled study of hydroxyzine and cetirizine in pregnancy. Ann Allergy Asthma Immunol 1997;78(2):183-6.
  6. Källén B. Use of antihistamine drugs in early pregnancy and delivery out- come. J Matern Fetal Neonatal Med 2002;11(3):146-52.
  7. NATO Advanced Research Workshop on “Drugs in pregnancy: consensus conference on teratogen information services,” Prague, 16–18 April 2004 [Abstract]. Reprod Toxicol 2004;19(2):258.