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A venous aneurysm is characterized by a localized dilated lesion in most major veins. Popliteal venous aneurysms (PVAs) are rare; however, they are one of the causes of deep vein thrombosis (DVT) and pulmonary thromboembolism (PTE), which can be critical due to the high mortality risk. We present a 21-year-old woman without prior medical history, who arrived by ambulance after having a transient cardio-pulmonary arrest. Contrast computed tomography revealed a massive PTE and a right PVA with a thrombus. Laboratory data suggested that she had no thrombotic predisposition. Therefore, we diagnosed her condition as a massive PTE that derived from a thrombus, which arose from the right PVA. After successful intravenous thrombolysis of the PTE and DVT, surgical plication of the right PVA was performed to prevent the recurrence of PTE. She has had no recurrence of PTE or DVT two years after surgical treatment. This case suggests that surgical plication might be an effective way of preventing recurrence in patients with PVA. LEARNING OBJECTIVE: Popliteal venous aneurysm (PVA) occurrence is rare, but it can result in deep vein thrombosis (DVT) and pulmonary thromboembolism (PTE). To treat our patient who suffered transient cardiac-pulmonary arrest caused by a massive PTE, we first used a recombinant tissue plasminogen activator and anticoagulant therapy. After the condition was stabilized, surgical plication of the right PVA was performed to prevent DVT recurrence. The present case suggests that surgical plication might be beneficial.

A major hurdle in pediatric formulation development is the lack of safety and toxicity data on some of the commonly used excipients. While the maximum oral safe dose for several kinds of excipients is known in the adult population, the doses in pediatric patients, including preterm neonates, are not established yet due to the lack of evidence-based data. This paper consists of four parts: (1) country-specific perspectives in different parts of the world (current state, challenges in excipients, and ongoing efforts) for ensuring the use of safe excipients, (2) comparing and contrasting the country-specific perspectives, (3) past and ongoing collaborative efforts, and (4) future perspectives on excipients for pediatric formulation. The regulatory process for pharmaceutical excipients has been developed. However, there are gaps between each region where a lack of information and an insufficient regulation process was found. Ongoing efforts include raising issues on excipient exposure, building a region-specific database, and improving excipient regulation; however, there is a lack of evidence-based information on safety for the pediatric population. More progress on clear safety limits, quantitative information on excipients of concern in the pediatric population, and international harmonization of excipients’ regulatory processes for the pediatric population are required.

Additional file 2: Figure S2 Chromatograms of compounded clonidine in the bottle “closed” condition on day 0 (a) and day 120 (b), in the “bottle (in use)” condition on day 0 (c) and day 120 (d), and in the “laminated paper” condition on day 0 (e) and day 120 (f).

Additional file 1: Figure S1 Chromatograms of 10 μg/mL clonidine (a), 10 μg/mL clonidine impurity 2,6-dichloroaniline (b), and solvent mixture (c).