Expert opinion on drug safety
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Expert Opin Drug Saf · Jul 2018
ReviewTeduglutide for the treatment of short bowel syndrome - a safety evaluation.
Teduglutide is an analog of glucagon-like peptide 2 (GLP-2) which is approved for the treatment of patients with short bowel syndrome (SBS) who are dependent on parenteral support. Areas covered: Short bowel syndrome is a rare condition that can result from extensive resection of small bowel, congenital abnormalities, or inflammatory conditions that leads to poor nutrient processing capacity of the intestine. In this review, the safety reported in controlled clinical trials and real-world experience with teduglutide are presented in depth. ⋯ This is an important treatment option for SBS patients given the well-established risks associated with parenteral support. The available data, albeit limited due to the small number of patients in the so-far performed studies, suggest that teduglutide appears to be safe to use in patients with intestinal failure who are dependent on parenteral support. However, additional long-term safety data are needed.
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Expert Opin Drug Saf · Jul 2018
ReviewAntimicrobial resistance and treatment: an unmet clinical safety need.
Infections due to multidrug-resistant (MDR) bacteria are burdened by high mortality rates. The development of new compounds to face the global threat of resistance is urgently needed. Combination regimens including "old" high-dose antimicrobials are currently limited by the risk of toxicity, resistance selection, and reduced efficacy. Following the Infectious Diseases Society of America call to develop 10 new antibacterials by 2020, new molecules are currently under development or have become available for use in clinical practice. ⋯ The availability of new compounds that show in vitro efficacy against MDR represents a unique opportunity to face the threat of resistance and to optimize the current use of antimicrobials, potentially reducing toxicity. Agents that are potentially active against MDR Gram-negatives are ceftozolane/tazobactam, new carbapenems and cephalosporins, the combination of avibactam with ceftazidime, and plazomicin. Further data from clinical trials and post-marketing studies for drugs targeting MDR pathogens are crucial to confirm their efficacy and safety.