Safety and Tolerability of More than Six Days of Tedizolid Treatment.

Tedizolid has demonstrated its efficacy and safety in clinical trials; however, data concerning its tolerability in long-term treatments are scarce. The aim of the study was to assess the indications and to describe the long-term safety profile of tedizolid. A multicentric retrospective study of patients who received tedizolid for more than 6 days was conducted. Adverse events (AEs) were identified from patients' medical records and laboratory data. The World Health Organization causality categories were used to discern AEs that were probably associated with tedizolid. Eighty-one patients, treated with tedizolid 200 mg once daily for a median (interquartile range [IQR]) duration of 28 (14 to 59) days, were included; 36 (44.4%) had previously received linezolid. The most common reasons for selecting tedizolid were to avoid linezolid potential toxicities or interactions (53.1%) or due to previous linezolid-related toxicities (27.2%). The most common indications were off-label, including prosthetic joint infections, osteomyelitis, and respiratory infections (77.8%). Overall, 9/81 patients (11.1%) experienced a probably associated AE. Two patients (2.5%) developed gastrointestinal disorders, 1 (1.2%) developed anemia, and 6 developed thrombocytopenia (7.4%) after a median (IQR) duration of treatment of 26.5 (17 to 58.5) days. Four (5%) patients discontinued tedizolid due to AEs. Among 23 patients with chronic renal failure (CRF), the rate of myelotoxicity was 17.4%, and only 8.7% had to stop tedizolid; 20 out of 22 with previous linezolid-associated toxicity had no AE. Long-term tedizolid treatments had good tolerance with rates of gastrointestinal AE and hematological toxicity lower than those reported with linezolid, particularly in patients with CRF and in those with a history of linezolid-associated toxicity.

Pharmacy and therapeutics committees strategy to address olmesartan safety issues at a primary care level.

Background Olmesartan, an antihypertensive drug, has been associated with a severe and potentially life-threatening sprue-like enteropathy, consisting of a serious, chronic diarrhoea and malabsorption syndrome. Treatment with this drug should be discontinued if patients develop such symptoms. Objective To retrospectively determine the reduction in olmesartan prescription following a strategy promoted by pharmacy and therapeutics committees within daily clinical practice to manage updated safety information on olmesartan. Setting Three primary healthcare centres. Method In May 2016, local pharmacy and therapeutics committees integrated by general practitioners, nursing staff and clinical pharmacists sent information about olmesartan safety issues to general practitioners, together with an individual list of their patients who were then being treated with olmesartan. Moreover, information about dose equivalents between angiotensin II receptor blockers and angiotensin II receptor blockers versus angiotensin-converting-enzyme inhibitors was also attached. The strategy aimed to promote individual benefit/risk assessment by general practitioners of the continuation of olmesartan treatment as a means to achieving a decrease in the risk of sprue-like enteropathy. The investigation team retrospectively reviewed the clinical records. Main outcome measure Reduction of olmesartan prescription. Results Olmesartan was discontinued in 44.4% of patients (197/444) in the year after the safety alert e-mail. In their medical records general practitioners registered that, after informing about olmesartan safety warnings, in four cases (0.9%), patients reported gastrointestinal symptoms. Conclusion A multidisciplinary strategy implemented to promote individual benefit/risk assessment regarding continuation of olmesartan treatment showed an important reduction in olmesartan prescriptions 1 year later.