American journal of therapeutics
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Review Case Reports
Sevoflurane hepatotoxicity: a case report of sevoflurane hepatic necrosis and review of the literature.
Sevoflurane, a halogenated anesthetic, is associated with mild aminotransferase elevations but does not tend to cause clinically significant hepatotoxicity. We report a rare case of severe hepatic necrosis following exposure to sevoflurane during surgery. A 37-year-old man presented with nausea,vomiting, abdominal pain, and jaundice on the third postoperative day after an abdominal wall mass resection. ⋯ The patient was likely susceptible to toxicity due to an underlying EBV infection and a probable history of exposure to halogenated anesthetics. Sevoflurane is generally considered to be relatively safe for subjects with mild liver dysfunction, in comparison with other halogenated anesthetics. However, this case suggests that sevoflurane can lead to severe life-threatening hepatic necrosis in at-risk individuals.
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The discovery of the anesthetic properties of chloroform by Sir James Simpson is one of the therapeutic triumphs of the 19th century. Queen Victoria requested chloroform anesthesia for the birth of her second son, Prince Leopold, and from then until the end of century chloroform was the most popular general anesthetic for obstetrics and surgery. Chloroform was so pleasant to inhale that it became a drug of abuse and was involved in all sorts of criminal activity. ⋯ Whicher," the Detective Inspector assigned to the case by Scotland Yard. According to Ms Summerscale's records, Mr Whicher ignored the possibility that chloroform was involved in Saville's death. However, evidence supports the view that chloroform played a critical role in the crime and indicates that the guilty plea by Samuel Kent's daughter, Constance, for which she spent 20 years to the day in prison, was as inaccurate as it was incomplete.
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Inadvertent or intentional metformin overdose can result in death from refractory lactic acidosis. We report a death from metformin-induced refractory lactic acidosis despite aggressive care. A 49-year-old hypertensive diabetic female presented 1 hour after ingesting 60 tablets of 500 mg metformin and 20 combination tablets of 12.5 mg hydrochlorothiazide/20 mg lisinopril. ⋯ She died 31.5 hours after her ingestion. Metformin concentrations decreased to 97 microg/mL 28 hours after the ingestion on CVVH, with a first-order elimination half-life of 11.3 hours (r(2) = 0.99) and a clearance of 56.2 mL/min. Further investigations on the place of CVVH in the management of the poisoned patient with MALA unable to hemodynamically tolerate conventional hemodialysis may be needed.
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The quality of clinical data submitted by manufacturers to support Food and Drug Administration cardiovascular device premarket approval (PMA) applications varies widely and formal quality assessment has not been previously performed. This study evaluated all original cardiovascular device PMAs with Food and Drug Administration decisions between January 1, 2000, and December 31, 2007, to assess the quality of clinical investigations submitted by manufacturers. Effectiveness and safety end points were judged high quality if they were clearly defined and associated with a specific time point for analysis. ⋯ Poorly defined safety and effectiveness end points, poor patient accounting, and incomplete collection of important patient comorbidities make device safety and effectiveness assessments more challenging. Women, pediatric, and nonwhite populations are underrepresented in premarket cardiovascular clinical trials. Manufacturers, regulators, and the clinical community should collaborate to address these study shortcomings to ensure that patients are treated with reliable, safe, and clinically useful medical devices.