OBJECTIVE: To determine whether generic simvastatin tablets and capsules obtained via the Internet from international markets are equivalent to the US innovator product regarding major aspects of pharmaceutical quality.

METHODS: Twenty simvastatin tablets and capsules were obtained for pharmaceutical analysis: 19 generic samples from international Internet pharmacy Web sites and the US innovator product. Tablet samples were tested according to US Pharmacopeial (USP) guidelines where applicable, using high-performance liquid chromatography, disintegration, dissolution, weight variation, hardness, and assessment of physical characteristics. These tests are often used to detect formulation defects of drug products during the manufacturing process.

RESULTS: Several international samples analyzed were not comparable to the US product in one or more aspects of quality assurance testing, and significant variability was found among foreign-made tablets themselves. Five samples failed to meet USP standards for dissolution and 2 for content uniformity. Among all samples, variability was observed in hardness, weight, and physical characterization.

CONCLUSIONS: Results suggest that manufacturing standards for the international generic drug products compared with the US innovator product are not equivalent with regard to quality attributes. These findings have implications for safety and effectiveness that should be considered by clinicians to potentially safeguard patients who choose to purchase foreign-manufactured drugs via the Internet.

OBJECTIVE:To describe and analyze CD4+ cell count and HIV RNA changes in HIV-infected patients receiving enfuvirtide and a prescribed background regimen (PBR) in a primarily clinical setting.

METHODS:A retrospective review from September 1998 through August 2005 of CD4+ cell counts and HIV RNA changes from baseline was conducted in patients receiving enfuvirtide. Data were stratified and analyzed according to baseline CD4+ cell count and HIV RNA.

RESULTS:A mean CD4+ cell count increase of approximately 102 cells/mm³was observed, regardless of baseline CD4+ cell count, in 187 patients receiving enfuvirtide during a mean of 19.4 months of follow-up. During 3 years of follow-up, patients initiating enfuvirtide at CD4+ cell counts less than 100 cells/mm³never achieved absolute CD4+ cell counts comparable to the counts in patients starting enfuvirtide at CD4+ cell counts of 100 cells/mm³or more. In 38.3% of patients achieving an undetectable HIV RNA level, a mean CD4+ cell count increase of 185 cells/mm³was observed. An unexpected finding was that a mean CD4+ cell count increase of 76 cells/mm³occurred in 61.7% of patients not achieving complete viral suppression.

CONCLUSIONS:Immunologic benefits were observed in subjects continuing enfuvirtide plus a PBR irrespective of baseline CD4+ cell count, complete viral suppression, or antiretroviral susceptibility data. Data suggest that initiation of enfuvirtide at CD4+ cell counts greater than 100 cells/mm³may be immunologically advantageous and independent of complete virologic response.

OBJECTIVE: To evaluate the appropriateness of use of dopaminergic agents in RLS management in an ambulatory care setting based on the most current scientific evidence.

METHODS: A retrospective drug utilization evaluation was conducted in patients who received levodopa or dopamine agonist for RLS from July 1, 2006, to July 31, 2007. Patients' medical records were reviewed and data were collected on demographics; comorbidities; laboratory values; doses of levodopa or dopamine agonists; prescribing physician's specialty; and use of alcohol, tobacco, and caffeine.

RESULTS: A total of 27 patients were included in the study for data collection and analysis. Twenty-two (81%) patients were on levodopa and 5 (19%) were on ropinirole. RLS severity was documented in only 2 (7%) patients. Serum ferritin levels and transferrin-iron saturation (Tsat) percentages were not obtained in 18 (67%) and 20 (74%) of the patients, respectively. Two (7%) patients had ferritin levels less than 50 ng/mL, and 7 (26%) patients had ferritin levels greater than 50 ng/mL. Fourteen (52%) patients were taking concurrent antidepressants and 6 (22%) were taking sedating antihistamines. Alcohol and tobacco use was documented in 2 (7%) and 8 (30%) patients, respectively. Twenty-six (96%) of the prescribing physicians were primary care providers.

CONCLUSIONS: The findings of this study confirm the need for provider education about the appropriate use of levodopa and dopamine agonists in patients with RLS. Appropriate use of these drugs may help decrease unnecessary adverse effects, complications, and costs.

OBJECTIVE: To compare the performance of CardioChek PA and Cholestech LDX.

METHODS: Staff members from the Colorado Prevention Center were included in the study, with all having fasted for 12 hours before the testing. No medical history was obtained. A venous blood sample was collected for lipid measurements conducted in a laboratory, and 2 finger sticks were obtained at that time and analyzed immediately on-site using the POC analyzers. Intraclass correlation coefficients (ICCs) were determined for each analyzer versus the laboratory analysis, with values greater than 0.75 defined as indicators of excellent reproducibility. We then assessed how interanalyzer differences in TC or HDL-C impacted the FRS lipid categorization.

RESULTS: Thirty-four adults (aged 24-56 y) participated in the study. The ICC between Cholestech LDX and the laboratory standard exceeded 0.75 for all 4 lipid categories (TC, = 0.96; HDL-C, = 0.88; low-density lipoprotein cholesterol, = 0.87; triglycerides, = 0.99). By contrast, the only ICC exceeding 0.75 using CardioChek PA was for triglycerides ( = 0.84). When applied in calculating the FRS, the Cholestech LDX analyzer misclassified fewer individuals for TC versus the CardioChek PA analyzer (5 vs 21). Overall, Cholestech LDX provided TC and HDL-C values in the correct FRS category more frequently versus CardioChek PA (TC, p < 0.001; HDL-C, p < 0.001). Limitations of the study include use of only 2 POC products and small sample size with no known risk factors. This project does not prove superior accuracy of either device, but reflects a real-world comparison of the analyzers conducted at a single center.

CONCLUSIONS: The Cholestech LDX analyzer demonstrated better reproducibility than the CardioChek PA analyzer when compared with laboratory gold standard analysis and allowed more accurate categorization for FRS. Since results obtained from these analyzers have the potential to impact treatment decisions, larger, prospective, comparative studies seem warranted.

OBJECTIVE: To establish individual AAT pharmacokinetics and develop a predictive model based on simple pharmacokinetic characterization that can be used to optimize individual AAT dosing regimens.

METHODS: Seven patients with severe hereditary AAT deficiency (PI^*ZZ phenotype) with serum AAT levels less than 0.50 g/L initially received AAT 180 mg/kg every 3 weeks. At 7, 14, and 21 days after AAT administration, serum samples were taken for quantitative AAT analysis and further one-compartment pharmacokinetic analysis. Subsequently, patients were rescheduled (dose and dosing interval) according to their individual responses. The influence of baseline AAT level, age, sex, body weight, and commercial AAT preparation was evaluated.

RESULTS: The mean ± SD AAT pharmacokinetic profile was: volume of distribution 127.6 ± 31.9 mL/kg, clearance 10.13 ± 1.84 mL/kg/day, and half-life 8.7 ± 1.0 days. Hence, the mean optimized final AAT dose was 123.1 mg/kg every 2 weeks (range 118.5-125.6). AAT concentrations differed by a mean (geometrical) value of 3.9% (range -4.2% to 6.7%) from the minimum desired AAT serum trough of 0.50 g/L. The impact of baseline AAT levels and commercial AAT preparation used was statistically significant (p = 0.033 and p = 0.035, respectively). Differences between estimated and actual values were slightly lower when baseline AAT levels were taken into consideration, with a mean value of 3.3% (range -4.2% to 6.1%).

CONCLUSIONS: AAT augmentation therapy can be effectively individualized on a pharmacokinetic basis with a simple, easily executed method.

OBJECTIVE: To assess patients' perceptions of EMDs, their acceptance of EMDs, and the relationship of these perceptions to medication adherence in African Americans with hypertension who are followed in community-based practices.

METHODS: Patients were recruited from a larger randomized controlled trial assessing the effect of motivational interviewing on medication adherence and blood pressure in hypertensive African American patients followed in 2 New York City primary care practices. Medication adherence was assessed with a Medication Event Monitoring System (MEMS) during a 12-month monitoring period. At the 12-month follow-up, patients' perceptions of the MEMS were assessed with a 17-item questionnaire. ANOVA was used to compare patients' responses (agree, neither, disagree) with the MEMS adherence over the monitoring period. Tukey's post hoc tests were used to determine whether there were significant differences among the 3 groups.

RESULTS: Participants were predominantly women, low-income, unemployed, had a high school education, and were a mean age of 53 years. Approximately two-thirds of the participants stated that the MEMS helped them remember to take their medications, 93% reported that the MEMS was easy to open, 85% did not find it stressful, and 75% liked the MEMS and used it everyday. One-third of patients preferred using a pillbox and 25% did not like traveling with the MEMS. Patients who stated that they used the MEMS every day, felt comfortable using it in front of others, and remembered to put refills in the MEMS had significantly better adherence over the study period than did those who disagreed (p ≤ 0.05).

CONCLUSIONS: African American patients treated for hypertension in community-based practices held positive perceptions about a MEMS. Perceptions about the practicality of a MEMS may yield important information about actual medication-taking behavior.

OBJECTIVE: To characterize data on DBSs associated with adverse event reports submitted to CAERS.

METHODS: We requested and obtained CAERS data from 1999 to 2003 involving adverse effects associated with the 6 most frequently used DBSs: Echinacea, ginseng, garlic, Ginkgo biloba, St. John's wort, and peppermint. We summarized and characterized the adverse event reports received, focusing on the composition of the DBSs and the nature of associated adverse events. We also cross-referenced reported single-ingredient DBSs with corresponding available product information. A sample of CAERS cases associated with signal DBSs was also characterized in detail.

RESULTS: CAERS reports involving ginseng DBSs were most frequently reported during the study period, whereas reports involving St. John's wort were the least frequently reported. Most CAERS reports involved multiple-ingredient DBSs, and 3-13% of reports involved multiple DBSs. Gastrointestinal and neurologic problems were the most common clinical outcomes among single-ingredient DBS-associated adverse events.

CONCLUSIONS: CAERS surveillance of DBS adverse effects is potentially as effective as other passive surveillance methods, but the number of reports is relatively small, validation is incomplete, and some inconsistencies within reports were found. Reports in CAERS may underrepresent DBS adverse events associated with DBS consumption.

DATA SOURCES: Relevant publications were identified through a systematic search of PubMed using the MeSH terms and key words hydroxocobalamin and cyanide. This search was then limited to human studies published since 2000. Systematic searches were conducted through January 2008. References from identified articles were reviewed for additional pertinent human studies.

STUDY SELECTION AND DATA EXTRACTION: The literature search retrieved 7 studies on the safety and/or efficacy of hydroxocobalamin in humans. Four new studies were identified by the search and 3 studies were identified from the references.

DATA SYNTHESIS: Studies of antidote efficacy in humans are ethically and logistically difficult. A preclinical study demonstrated that intravenous doses of hydroxocobalamin 5 g are well tolerated by volunteer subjects. Hydroxocobalamin has been shown to reduce cyanide concentrations in controlled studies of nitroprusside therapy and in heavy smokers. A retrospective study of 14 acute cyanide poisonings also demonstrated hydroxocobalamin's safety and efficacy. Two studies examining hydroxocobalamin for smoke inhalation-associated cyanide poisoning indicated a possible benefit, but they are insufficient to establish definitive criteria for use in this setting. Randomized controlled trials of hydroxocobalamin and traditional cyanide antidotes (nitrites/thiosulfate) are lacking.

CONCLUSIONS: Cyanide poisoning can rapidly cause death. Having an effective antidote readily available is essential for facilities that provide emergency care. In cases of cyanide ingestion, both the nitrite/thiosulfate combination and hydroxocobalamin are effective antidotes. Hydroxocobalamin offers an improved safety profile for children and pregnant women. Hydroxocobalamin also appears to have a better safety profile in the setting of cyanide poisoning in conjunction with smoke inhalation. However, current data are insufficient to recommend the empiric administration of hydroxocobalamin to all victims of smoke inhalation.

DATA SOURCES: A literature search was performed using MEDLINE (1950-January 2008), EMBASE, PubMed, and abstracts from major HIV conferences (February 2001-October 2007). These searches were limited to human data published in English and used the key words bisphosphonates, calcitonin, raloxifene, teriparatide, HAART, osteopenia, osteoporosis, and HIV/AIDS. Additional articles were retrieved from citations of selected references.

STUDY SELECTION AND DATA EXTRACTION: Relevant information on the pharmacology, pharmacokinetics, safety, and efficacy of available treatment with hormonal and nonhormonal agents was selected. Greater emphasis was placed on randomized clinical trials than on retrospective studies.

DATA SYNTHESIS: Osteoporosis in HIV-infected persons is at least as prevalent as in postmenopausal women, yet this population is not listed in primary care guidelines as one that should be considered for screening. In addition to bisphosphonates, calcitonin, raloxifene, and teriparatide are used to treat bone disorders. Three clinical trials to date have evaluated the use of a bisphosphonate in HIV-infected persons. The trials showed a marked increase in bone mineral density in patients taking alendronate versus those in the control groups (with/without calcium, exercise, and/or vitamin D in 1 or both arms). Dosing restrictions complicate the use of these agents; diet, exercise, and calcium supplementation remain the foremost recommended strategies to prevent bone loss. The use of estrogen, testosterone, calcitonin, and teriparatide is less studied in HIV-positive patients, but may be considered in select cases. There are some investigational drugs and agents not available in the US; however, there are not enough data to support their use.

CONCLUSIONS: Alendronate appears to be a promising treatment option for HIV-infected patients with osteoporosis and osteopenia. Further research is required to determine the safety and efficacy of other available drugs. Until additional information is provided, and with available knowledge on the metabolism profiles of antiretroviral and bone ossification agents, alendronate appears to be the preferred agent to use in this population.

DATA SOURCES: A literature search was conducted using PubMed, International Pharmaceutical Abstracts, and MEDLINE, from inception to January 2008, combining the term warfarin individually with ciprofloxacin, levofloxacin, and moxifloxacin. These 3 quinolones were selected based on their commercial availability and use in the US.

STUDY SELECTION AND DATA EXTRACTION: All publication types including human participants and published in English were eligible for review. Reports were selected based on the use of typical treatment courses of fluoroquinolones during concomitant warfarin therapy and the reporting of prothrombin time (PT) or international normalized ratio (INR).

DATA SYNTHESIS: Twenty-two publications were evaluated including 16 case reports or case series, 2 retrospective cohort studies, and 4 prospective studies, which included 2 placebo-controlled investigations. Identified reports covered a wide range of patient ages with multiple comorbidities. Changes in PT and INR values were considerably variable and inconsistent during concomitant warfarin and fluoroquinolone therapy. Results from the 6 structured reports demonstrated mean increases in PT and INR values that were clinically insignificant. However, some patients experienced significant increases above the desired therapeutic range. Increased anticoagulation was typically observed within the first week of concomitant fluoroquinolone therapy. Bleeding complications during times of increased anticoagulation were not always observed, but did result in death for 2 patients.

CONCLUSIONS: Published data show no consistent increase in anticoagulant effects during concomitant warfarin and 3 commonly prescribed fluoroquinolones. Therefore, more frequent monitoring during concomitant therapy would be prudent.

DATA SOURCES: Literature was accessed through MEDLINE (1966-January 2008) and the Cochrane Library using the terms laryngeal edema, airway obstruction, postextubation stridor, intubation, glucocorticoids, and corticosteroids. Bibliographies of cited references were reviewed and a manual search of abstracts from recent pulmonary and critical care meetings was completed.

STUDY SELECTION AND DATA EXTRACTION: All English-language, placebo-controlled, randomized studies evaluating the use of prophylactic corticosteroids for the prevention of postextubation laryngeal edema or postextubation stridor (PES) in adults were reviewed.

DATA SYNTHESIS: Although laryngoscopy is the gold standard method for diagnosing PELE, PES is more commonly used for diagnosis in clinical practice. While 3 older studies failed to demonstrate benefit with the prophylactic administration of corticosteroid therapy in terms of reducing PELE, PES, or the need for reintubation, each of these studies evaluated only a single dose of steroid therapy that was initiated only 30-60 minutes prior to a planned extubation in a population of patients at low-risk for PELE. In comparison, 3 newer studies, each using 4 doses of corticosteroid therapy initiated 12-24 hours prior to a planned extubation in patients deemed to be at high baseline risk for developing PELE, demonstrated a reduction in PELE, PES, and the need for reintubation; no safety concerns were identified. Current evidence therefore suggests that prophylactic intravenous methylprednisolone therapy (20-40 mg every 4-6 h) should be considered 12-24 hours prior to a planned extubation in patients at high-risk for PELE (eg, mechanical ventilation >6 days).

CONCLUSIONS: Data from the most recent well-designed clinical trials suggest that prophylactic corticosteroid therapy can reduce the incidence of PELE and the subsequent need for reintubation in mechanically ventilated patients at high-risk for PELE. Based on this information, clinicians should consider initiating prophylactic corticosteroid therapy in this population. Further studies are needed to establish the optimal dosing regimens as well as the subgroups of patients at high risk for PELE who will derive the greatest benefit from this preventive steroid therapy.

DATA SOURCES: A search of MEDLINE (1950-January 2008), PubMed (1950-January 2008), and the Iowa Drug Information System (1966-January 2008) was performed using the search terms tamsulosin and extracorporeal shock wave lithotripsy. MeSH headings included lithotripsy and adrenergic -antagonists. Additional references were found by searching bibliographic references of resulting citations.

STUDY SELECTION AND DATA EXTRACTION: All studies utilizing tamsulosin therapy after a single session of ESWL or after the development of steinstrasse, an accumulation of stone fragments that obstructs the ureter, were included.

DATA SYNTHESIS: To date, 5 prospective studies have evaluated the efficacy of tamsulosin combined with ESWL in enhancing the passage of renal and ureteral stones. In one trial, 12-week renal stone clearance was 60% in the control group compared with 78.5% in the tamsulosin group (p = 0.037). Among trials that evaluated overall ureteral stone clearance, efficacy rates were 33.3-79.3% in the control groups compared with 66.6-96.6% in the tamsulosin groups. Reports of pain and supplemental analgesic dosing were consistently lower with tamsulosin, but data on the incidence of subsequent retreatment with ESWL or ureteroscopy was rarely reported. Adjunctive tamsulosin particularly enhanced the passage of renal stones 10-24 millimeters in diameter. Overall, tamsulosin was well tolerated.

CONCLUSIONS: Overall, evidence suggests that adjunctive tamsulosin therapy combined with ESWL is safe and effective in enhancing stone clearance in patients with renal stones 10-24 millimeters in diameter. Evidence regarding ureteral stone clearance is inconclusive, although adjunctive tamsulosin has been reported to reduce painful episodes. Larger prospective trials evaluating different dosages and stone locations, as well as the ability of tamsulosin to reduce repeat ESWL or more invasive methods such as ureteroscopy should be performed.

DATA SOURCES: Primary literature was identified through MEDLINE (1950-February 2008), EMBASE (1988-February 2008), and International Pharmaceutical Abstracts (1970-February 2008) using the search terms voriconazole, ritonavir, protease inhibitors, nonnucleoside reverse transcriptase inhibitors, raltegravir, maraviroc, and drug interactions. Additionally, relevant abstracts from infectious diseases and HIV conferences (2004-February 2008), reference citations from relevant publications, and product information monographs were reviewed.

STUDY SELECTION AND DATA ABSTRACTION: All articles identified from the data sources and published in English were reviewed. Of these, studies and reports addressing voriconazole pharmacokinetics or interactions with antiretroviral agents were evaluated.

DATA SYNTHESIS: The interactions between voriconazole and antiretroviral drugs are complex. Voriconazole and ritonavir exhibit a time- and dose-dependent interaction. Ritonavir initially inhibits voriconazole metabolism, but, with chronic administration, subsequently induces voriconazole metabolism. This interaction is more pronounced with high doses of ritonavir. Coadministration of voriconazole and efavirenz at usual doses is contraindicated because of a 2-way interaction resulting in efavirenz toxicity and decreased therapeutic effect of voriconazole. Dosage adjustments of both drugs are required. Based on pharmacokinetic characteristics, interactions between voriconazole and other protease inhibitors, nonnucleoside reverse transcriptase inhibitors (including etravirine), and maraviroc are likely but have not been well characterized in the literature. Interactions between voriconazole and nucleoside reverse transcriptase inhibitors or raltegravir are not anticipated.

CONCLUSIONS: Interactions between voriconazole and antiretrovirals have the potential for serious consequences. However, because there is limited information available, further studies are warranted to establish these interactions and clarify their appropriate management. Until then, clinicians should be aware of the potential for interactions between voriconazole and antiretroviral agents and how to monitor for these interactions in clinical practice.

CASE SUMMARY: A 62-year-old man with a history of coronary artery disease, multiple acute coronary syndromes requiring percutaneous coronary interventions with multiple stent placements, and acute stent thrombosis resulting in ST segment elevation myocardial infarction presented to the hospital with chest pain. The chest pain was not relieved by 4 sublingual nitroglycerin tablets. Five days prior to his presentation, the patient had been instructed to discontinue both aspirin and clopidogrel in preparation for a left ankle fusion procedure. He was taken to the cardiac catheterization laboratory where he was found to have thrombosis in a sirolimus-eluting stent placed more than 3 years ago. Thrombectomy and balloon angioplasty were performed, and the patient completed his hospital course without complications.

DISCUSSION: Stent thrombosis associated with drug-eluting stents is a complicated pathophysiologic phenomenon with multiple patient-, procedure-, and device-related factors. Application of these risk factors to quantify the risk of stent thrombosis as they apply to a single patient is unknown. Discontinuation of recommended dual antiplatelet therapy with aspirin plus a thienopyridine has been identified as a major risk factor for stent thrombosis, but the optimal duration of dual antiplatelet therapy remains unknown. Current recommendations suggest extending dual antiplatelet therapy beyond one year in patients with low bleeding risk.

CONCLUSIONS: Given the overall data at this time and the severity of stent thrombosis, it seems prudent to continue dual antiplatelet therapy with aspirin indefinitely plus a thienopyridine for at least one year, with continuation beyond one year on a case-by-case basis depending on the risks of in-stent thrombosis and bleeding. In patients with a low risk of bleeding, indefinite continuation of dual antiplatelet therapy may be reasonable.

CASE SUMMARY: A 52-year-old man presented with low-grade fever and fatigue that had been present for 4 months. He had been receiving insulin for 5 years and rosiglitazone 4 mg/day for 11 months for control of type 2 diabetes; he was receiving no other drug therapy. During hospitalization, hepatotoxicity was shown, with abnormal liver function test results including alanine aminotransferase 488 U/L, aspartate aminotransferase 344 U/L, alkaline phosphatase 832 U/L, total bilirubin 4.61 mg/dL, and direct bilirubin 3.63 mg/dL. Rosiglitazone was discontinued after further elevation of bilirubin (total 14.67 mg/dL, direct 12.10 mg/dL) occurred. Other causes for hepatotoxicity were ruled out. Hodgkin's lymphoma was diagnosed during the workup; however, liver imaging and biopsy also excluded this as the direct cause of acute liver failure. Despite discontinuation of rosiglitazone, the bilirubin level continued to increase to 49.29 mg/dL (direct >20 mg/dL).The patient died 3 months after admission.

DISCUSSION: Rosiglitazone maleate is a thiazolidinedione approved for treatment of type 2 diabetes mellitus. The first member of this drug class, troglitazone, was withdrawn from the market due to reports of acute liver failure. Rosiglitazone has been shown to be much safer than troglitazone, despite some reported cases of early-onset nonfatal hepatotoxicity. Use of the Naranjo probability scale indicated that rosiglitazone was the probable cause of acute liver failure in our patient.

CONCLUSIONS: We conclude that rosiglitazone may be associated with late-onset acute liver failure. Clinicians should be aware of such a complication and monitor liver function in patients receiving the drug.

CASE SUMMARY: A 35-year-old man receiving daptomycin 4 mg/kg (275 mg) intravenously once daily (started 5 wk prior to presentation for presumed osteomyelitis) presented to the emergency department with elevations in serum creatinine and hepatic transaminase levels. He did not experience creatine kinase (CK) elevation or rhabdomyolysis. Following discontinuation of daptomycin, his renal and hepatic function improved.

DISCUSSION: To our knowledge, this is the first case of daptomycin-induced hepatotoxicity with acute renal failure in the absence of rhabdomyolysis and CK abnormalities. Previously published case reports described patients with a variety of elevations in liver function tests, serum creatinine, and CK with daptomycin. In our patient, the acute renal and hepatic toxicity was probable according to the Naranjo probability scale.

CONCLUSIONS: Although daptomycin is a well-tolerated antibacterial agent, clinicians should consider periodic monitoring of liver function and renal function tests to identify potential adverse effects.

CASE SUMMARY: A 20-year-old 27-week pregnant patient with a history of spina bifida, neurogenic bladder, and multiple hospitalizations for recurrent urinary tract infections (UTIs) was diagnosed with pyelonephritis. She was treated with daptomycin 260 mg (4 mg/kg) daily for 14 days on the basis of a urine culture that revealed E. faecium resistant to ampicillin, nitrofurantoin, and vancomycin. All cultures following treatment revealed no growth, and the patient as well as the neonate displayed no adverse effects.

DISCUSSION: VRE UTIs can be treated safely in pregnancy with nitrofurantoin, if the organism is susceptible. Other viable options in the treatment of VRE, including linezolid, doxycycline, and quinupristin/dalfopristin, have lower urinary concentrations, teratogenic risk, or limited findings regarding their safety in pregnancy. Daptomycin was selected in this case due to its efficacy in the treatment of VRE, high urinary concentrations, pregnancy category B, and one case report indicating its successful use in pregnancy.

CONCLUSIONS: Treatment of VRE in pregnancy can be challenging due to the teratogenicity or unknown safety of available options. The use of daptomycin in our patient enabled a successful outcome of multidrug-resistant E. faecium in a complicated pregnant patient without observed neonatal abnormalities.