The outcomes of pregnancy in women exposed to newly marketed drugs in general practice in England

Abstract

Objective To determine the proportion and nature of congenital anomalies in babies born to Design Non-interventional observational cohort studies. MethodsThe women were identified in confidence by the Prescription Pricing Authority. The doctor was sent a questionnaire to determine clinical events, including pregnancy, occurring after the drug was dispensed. A supplementary questionnaire determined the outcome of each reported pregnancy.women exposed to newly marketed drugs during the first trimester.Setting General medical practice in England. Population Women exposed to newly marketed drugs in whom pregnancy was recorded.Main outcome measures Outcomes of pregnancies, the proportion and nature of congenital anomalies in the babies born.Results 251 1 pregnancies were reported. In 831 of these pregnancies a newly marketed drug had been taken during the first trimester and in 74 during the secondkhird trimester. The outcome was ascertained for 780 (94'1/0) of these 831 pregnancies: 547 (66'Yo) births; 10 (1%) ectopic pregnancies; 94 (1 1%) spontaneous miscarriages; 5 (< 1%) missed abortions; 120 (14%0) legal abortions; and 4 (C 1%) intrauterine deaths. 557 infants were born, of whom 14 (2.5%) had congenital anomalies. ConclusionsThe proportion of live infants with a congenital abnormality born to mothers exposed to newly marketed drugs in the first trimester was similar to the percentage of congenital anomalies estimated by the Ofice for National Statistics. These data add valuable information to the safety database of these drugs.

Clinical effectiveness, tolerability and cost-effectiveness of newer drugs for epilepsy in adults: a systematic review and economic evaluation

“…No congenital anomalies were observed among 11 births exposed to GBP in the first trimester. 171 One RCT of rapid versus slow initiation, 173 eight uncontrolled trials (four in epilepsy (n = 2986) [174][175][176][177] and four in bipolar disorder (BPD) (n = 60), 178,181,451 four open-label extension studies in epilepsy [182][183][184][185] and one uncontrolled cohort study of patients with spinal cord injury 186 were identified. These studies are summarised in Appendix 25, Table 100.…”

“…171,188 These reports are summarised in Appendix 25, Tables 101 and 108. PEM of 11,316 epilepsy patients identified seven cases of Stevens-Johnson syndrome (SJS) in adults, four on concomitant VPA.…”

“…Two reports of PEM in the UK were identified 170,171 (Appendix 25, Tables 99 and 108). These studies were conducted by the Drug Safety Research Unit, whose methods are reported elsewhere.…”

Guidelines for choice of selective serotonin reuptake inhibitor in depressive illness

“…There was not a higher than expected incidence of spontaneous, missed or legal abortions, ectopic pregnancies, intra-uterine deaths or congenital abnormalities (Wilton et al, 1998). Goldstein & Sundell (1999) reviewed five prospective surveys and four published cohortcontrolled studies of women who received SSRIs during pregnancy.…”

Losartan: a study of pharmacovigilance data on 14 522 patients

“…[5][6][7][8] PEM provides a numerator and a denominator over a known time frame: it permits, therefore the calculation of the incidence density for each reported event. Thus:…”