Frågedatum: 2003-03-14
RELIS database 2003; id.nr. 19716, DRUGLINE
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Can treatment with Seretide (salmeterol, fluticasone), Singulair (montelukast) and Bricanyl (terbut



Fråga: Can treatment with Seretide (salmeterol, fluticasone), Singulair (montelukast) and Bricanyl (terbutaline) be continued during pregnancy? A woman pregnant in week 7 is currently treated with salmeterol, fluticasone, montelukast and terbutaline for asthma. Administered doses unknown. The patient has daily asthmatic symptoms.

Sammanfattning: Uncontrolled asthma during pregnancy may increase the risk of perinatal complications and therefore the goal for treatment must be control of the asthmatic symptoms. The prophylactic drug of choice is inhaled corticosteroids, like fluticasone, which could be combined with beta2-agonists, like terbutaline.

Long-acting beta2-agonists, like salmeterol, are not recommended but may be of use in women with inadequate effect of inhaled corticosteroids. Human data on leukotriene modifiers, like montelukast, is limited. Montelukast is not recommended but may be used in patients with recalcitrant asthma who have responded well to the treatment prior pregnancy.

Svar: Uncontrolled asthma increases the risk of perinatal complications compared to healthy mothers or mothers with adequately controlled asthma (1).

Use of salmeterol during pregnancy has already been documented in Drugline (2). There are 1359 reports of women exposed to salmeterol and 51 malformations (3.8%) (99% CI 2.4-5.1) in the Swedish Medical Birth Registry. Total frequency of malformations in the population is 3.5% (3). No increased risk for malformations is observed. Salmeterol should not be recommended in general, but may be used by women who do not get adequate effect by inhaled corticosteroids and who have responded well to salmeterol before pregnancy (1).

Questions concerning inhalation of corticoids during pregnancy have been answered previously (4). Inhaled corticosteroids should generally be the prophylactic drug of choice in pregnant women (1). In the Swedish Medical Birth Registry there are 424 women exposed to fluticasone and 20 malformations (4.7%) (99% CI 2.1-7.4). Among 9411 women exposed to inhaled corticosteroids 352 malformations (3.7%) (99% CI 3.2-4.2) were seen (3). The number of fluticasone exposed women is limited and there is no reason to expect fluticasone to be more teratogenic than other inhaled corticosteroids.

Montelukast is a relatively new drug on the market and reports about montelukast use during pregnancy are few. In the Swedish Medical Birth Registry there are 41 reports of women exposed during pregnancy and one malformation. The number of exposed women is to small to allow a proper risk assessment (3). In both animal and human studies no teratogenic effects have been reported but available human data are limited (4). Use of montelukast during pregnancy is generally not recommended but might be considered in patients with recalcitrant asthma who have responded well to montelukast prior pregnancy (1).

Questions concerning terbutaline use during pregnancy have been answered prior in Drugline (5-6). Terbutaline is widely used for asthma during pregnancy and in Swedish Medical Birth Registry there are 11 456 women exposed to terbutaline during pregnancy reported and 445 children (3.9%) (99% CI 3.4-4.4) with malformations (3).

Combination treatment is common during pregnancy, which makes it hard to determine which substance that gives increased risk for malformation.

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