In 1983 a postal survey of the bronchoscopic practice of chest physicians in the United Kingdom produced a 90% response rate. Two hundred and thirty one physicians were carrying out bronchoscopy; they had performed about 40 000 bronchoscopies in the preceding year, 87% of these being fibreoptic procedures with topical anaesthesia. The mortality rate of fibreoptic bronchoscopy was 0.04%, with a 0.12% incidence of major complications. Transbronchial biopsy carried both an appreciably higher mortality rate of 0.12% and a major complication rate of 2.7%. There is wide variation in the use and choice of sedative drugs for fibreoptic bronchoscopy. Many of the drug combinations could be criticised on pharmacological grounds. The mean dose of lignocaine was 342 mg, most operators exceeding the usual maximum recommended dose; but adverse reactions were rare. Routine supplemental oxygen was given by only 18% of bronchoscopists. Basic resuscitation equipment was often inadequate. Radiological screening was used for transbronchial lung biopsy by 53% of respondents and significantly reduced the incidence of pneumothorax from 2.9% to 1.8%. Both the number of bronchoscopies performed and the complication rate were higher than previous estimates. Bronchoscopists should re-examine their policy on drugs and safety precautions to minimise the risks of the procedure.
Background: Teriflunomide is contraindicated in pregnancy. Some pregnancies have occurred despite guidance to use effective contraception. Objectives: To report outcomes of pregnancies occurring in teriflunomide clinical trials and the post-marketing setting. Methods: Outcomes are summarized for pregnancies in teriflunomide monotherapy clinical trials and the post-marketing setting (data cutoff: December 2017). Results: Of 437 confirmed teriflunomide-exposed pregnancies, 222 had known outcomes (70 from clinical trials; 152 from the post-marketing setting); 161 were reported prospectively and 61 retrospectively. There were 107 (48.2%) live births, 63 (28.4%) elective abortions, 47 (21.2%) spontaneous abortions, 3 (1.4%) ectopic pregnancies, 1 (0.5%) stillbirth, and 1 (0.5%) maternal death leading to fetal death. Four birth defects were reported among cases with known pregnancy outcome: ureteropyeloectasia (only defect considered major); congenital hydrocephalus; ventricular septal defect; and malformation of right foot valgus. A case of cystic hygroma was identified on antenatal ultrasound (pregnancy outcome unknown). One elective abortion followed prenatal diagnosis of fetal anomaly (blighted ovum). The risk of major birth defects in prospectively reported live birth/stillbirth outcomes was 3.6% (1/28) in clinical trials and 0.0% (0/51) in post-marketing reports. Conclusions: Outcomes were consistent with the general population. Current human data do not indicate a teratogenic signal in teriflunomide-exposed pregnancies.
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