Purpose:To assess the effect of neuraminidase inhibitor (NI), zanamivir, on pregnancy outcomes.Keywords: Influenza; Pregnancy; Drug safety; Zanamivir; Congenital anomalies Abstract ISSN: 2348-9782 Influenza is the most common cause of serious respiratory illness worldwide [1]. In the United States, influenza causes approximately 36,000 deaths and 226,000 hospitalizations in an average season [2]. The 2009 H1N1 influenza pandemic led to greater morbidity and mortality, particularly for those aged less than 65 years. Pandemic influenza affected over 214 countries in 2009 and caused over 18,500 laboratory-confirmed deaths. Globally, there were an estimated 201,200 respiratory deaths (range: 105,700-395,600) with an additional 83,300 cardiovascular deaths (range: 46,000-179,900) associated with 2009 pandemic influenza A H1N1 [3].
Methods:The Health Improvement Network (THIN) provided data from UK General Practitioners (GPs) for 144 pregnant women who were prescribed zanamivir and 144 age-and date-matched untreated comparators with no recorded diagnosis of influenza. Groups were assessed for baseline characteristics, treatment-emergent diagnoses in the mother, pregnancy outcomes and congenital malformations diagnosed in the offspring within 28 days of birth.Results: Treatment and comparator groups were similar at baseline. Most (100/144) zanamivir prescriptions occurred during the second and third trimesters. Groups were similar in recorded smoking during pregnancy; more women in the comparator group had recorded alcohol use. The zanamivir group had more diagnoses compatible with influenza-like illness (ILI) and was more often prescribed antibiotics, analgesics and medicines for respiratory and gastrointestinal symptoms. Pregnancy outcomes other than live birth were not found in the GP record, possibly due in part to cohort entry having occurred late in most pregnancies. There was no difference between groups in the risk of any treatment-emergent diagnosis. Congenital anomalies occurred in similar proportions, but infants born to zanamivir-exposed women had substantially fewer diagnoses from the cluster of cardiac defects consisting of atrial and ventricular septal defects and patent ductus arteriosus (1 zanamivir, 6 comparators).Conclusions: Zanamivir-exposed pregnant women have a wide range of symptoms of and treatments for ILI that complicate comparisons with untreated women. There was no indication of increased risk to the mother, the pregnancy or the infant following exposure. McLean and Pebody (2010) estimated a total of 784,000 (range: 372,000 -1,638,000) clinical cases of influenza-like illness (ILI) due to pandemic H1N1 2009 in England [4]. From the beginning of the pandemic to April 2010, 2,831 patients were hospitalized with confirmed pandemic H1N1 2009 infection. While pregnant women were not at increased risk of influenza infection, once infected, they were five times more likely to be hospitalized (RR 5.1; 95%CI 4.2 -6.1) and seven times more likely to die, in comparison to healthy females of child-b...