Pharmacokinetic Evaluation in Pregnancy-Current Status and Future Considerations: Workshop Summary.

As pregnant individuals have traditionally been excluded from clinical trials, there is a gap in knowledge at the time of drug approval regarding safety, efficacy, and appropriate dosing for most prescription medications used during pregnancy. Physiologic changes in pregnancy can result in changes in pharmacokinetics that can impact safety or efficacy. This highlights the need to foster further research and collection of pharmacokinetic data in pregnancy to ensure appropriate drug dosing in pregnant individuals. Therefore, the US Food and Drug Administration and the University of Maryland Center of Excellence in Regulatory Science and Innovation hosted a workshop on May 16 and 17, 2022, titled "Pharmacokinetic Evaluation in Pregnancy." This is a summary of the workshop proceedings.

Alleviation of severe compressive symptoms in a patient with advanced lung carcinoma using tracheal and superior vena cava stents.

Lung cancer is now the leading cause of death from cancer worldwide. Although surgery remains the treatment of choice, the majority of patients will be unresectable at presentation with a poor survival outcome. In those patients who also have tracheobronchial involvement; the aim of intervention is to restore airway patency, thus improving quality of life in a minimally invasive way. Superior vena cava (SVC) infiltration by lung carcinoma is present in 3%-5% of patients with lung cancer. In patients with malignant SVC syndrome, the average life expectancy is 3 to 10 months. In these cases the disease progresses rapidly and obstruction develops before there is time for collaterals to develop. We present a case of a 75-year-old man who had alleviation of severe compressive symptoms secondary to advanced lung carcinoma using tracheal and SVC stents placed as a single procedure.

Decision analysis of retrievable inferior vena cava filters in patients without pulmonary embolism.

BACKGROUND: Retrievable filters are increasingly implanted for prophylaxis in patients without pulmonary embolism (PE) but who may be at transient risk. These devices are often not removed after the risk of PE has diminished. This study employs decision analysis to weigh the risks and benefits of retrievable filter use as a function of the filter's time in situ. METHODS: Medical literature on patients with inferior vena cava (IVC) filters and a transient risk of PE were reviewed. Weights reflecting relative severity were assigned to each adverse event. The risk score was defined as weight × occurrence rate and combines the frequency and severity for each type of adverse event. The value function in the decision model combines the following risks: (1) risk in situ; (2) risk of removal, and (3) relative risk without filters. A decreasing net risk score represents a net expected benefit, and an increasing net risk score indicates the expected harm outweighs the expected benefit. RESULTS: The net risk score reaches its minimum between day 29 and 54 postimplantation. This is consistent with an increasing net risk associated with continued use of retrievable IVC filters in patients with transient, reversible risk of PE. The results were insensitive to reasonable variations in the assessed weights and adverse event occurrence rates. CONCLUSIONS: For patients with retrievable IVC filters in whom the transient risk of PE has passed, quantitative decision analysis suggests the benefit/risk profile begins to favor filter removal between 29 and 54 days after implantation.