News

News

June 13, 2018

June ID Update

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. Links marked with an asterisk (*) provide details to Web Edition subscribers, while all other links are universal. If you would like to automatically receive our monthly ID Updates by e-mail, subscribe now.
 

June 2018

 

Drug Safety Communications

  • The US FDA has issued a Drug Safety Communication regarding the possible increased risk of neural tube defects among infants born to women who became pregnant while on a dolutegravir-based regimen, based on preliminary results from an ongoing observational study in Botswana. There is no evidence from this study of neural tube defects occurring among infants born to women who initiated a dolutegravir-based regimen after becoming pregnant. Dolutegravir is available as a single agent (brand name Tivicay*) and is also part of the combination products Juluca* and Triumeq*. The full Drug Safety Communication can be found here. The most current recommendations from the HHS Antiretroviral Guidelines Panels, with clinical scenarios and alternatives to treatment with dolutegravir, can be found here. An interim statement from CDC can be found here.

CDC Health Alert Network #411

  • HAN #411 provides current CDC recommendations on the management and reporting of Shigella* infections that have been treated with ciprofloxacin or azithromycin and resulted in possible clinical treatment failure. This is a follow-up to HAN #401 (April 2017) which described an increase in the percentage of Shigella isolates in the US with ciprofloxacin MICs of 0.12–1 μg/mL (classified as susceptible by CLSI criteria). This percentage continues to rise. Molecular data indicate that Shigella isolates in this ciprofloxacin MIC range harbor at least one quinolone resistance mechanism. CDC has also identified an increasing number of Shigella isolates with azithromycin MICs that exceed the epidemiological cutoff value (ECV), and requests reports of any possible azithromycin treatment failures.

New or Updated Treatment Guidelines

Antiretroviral Labeling Changes

  • The approved labeling for darunavir/cobicistat (Prezcobix*) now specifically states that this combination product is not recommended for use in pregnant women due to substantially lower exposures of darunavir and cobicistat. Treatment should not be initiated in pregnant women, and an alternative regimen should be used in women who become pregnant during Prezcobix therapy. 
  • The US FDA has approved once-daily oral emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (Truvada*), in combination with safe sex practices, for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in at-risk adolescents weighing at least 35 kg. Truvada was approved for PrEP in adults in 2012.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • [New on the list]: Cefazolin, Nitrofurantoin oral suspension (unavailable), Recombinant zoster vaccine (Shingrix)
    • [Shortage recently resolved]: Doxycycline injection, Oseltamivir oral suspension, Penicillin G benzathine/Penicillin G procaine 1.2 million units (Bicillin C-R)
    • [Continue to be in reduced supply]:
      • Aminoglycosides: Amikacin injection, Gentamicin ophthalmic ointment (unavailable), Tobramycin injection
      • Cephalosporins: Cefepime, Cefotaxime injection (unavailable), Cefoxitin, Cefpodoxime oral suspension, Ceftazidime, Ceftriaxone, Cefuroxime injection (unavailable)
      • Fluoroquinolones: Ciprofloxacin injection, Ciprofloxacin oral suspension, Moxifloxacin injection (unavailable)
      • Penicillins: Amoxicillin/clavulanate 1000 mg/62.5 mg ER tablets, Ampicillin/sulbactam, Oxacillin injection, Penicillin G procaine injection (unavailable), Piperacillin/tazobactam
      • Other antibacterials: Azithromycin injection, Clindamycin injection, Dalbavancin injection, Erythromycin lactobionate injection (unavailable), Metronidazole injection, Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Vancomycin injection
      • Antifungal drugs: Fluconazole injection
      • Antiparasitic drugs: None
      • Antiviral drugs: None
      • Vaccines: Hepatitis A Virus Vaccine Inactivated (Vaqta), Hepatitis B vaccine recombinant, Yellow Fever vaccine (YF-VAX is unavailable, but Stamaril can be obtained through a limited number of clinics in the US. Click here).
  • Antimicrobial drugs newly discontinued: Quinidine gluconate IV (in December 2017). Product distribution will continue until expiration of current stock (March 2019).
    • Recent discontinuations: Terbinafine granules (in May 2017), MenHibrix (in February 2017), Elvitegravir (Vitekta, in December 2016), Peginterferon alfa-2b (in February 2016; 50 mcg vials still available in limited quantities), Boceprevir (in December 2015), Permethrin 1% topical lotion (in September 2015)
May 7, 2018

May ID Update

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. Links marked with an asterisk (*) provide details to Web Edition subscribers, while all other links are universal. If you would like to automatically receive our monthly ID Updates by e-mail, subscribe now.

 

May 2018

  

New Drug Approvals

  • Cimduo* (lamivudine, tenofovir disoproxil fumarate) for the treatment of HIV-1 infection (in combination with other antiretroviral agents) in adult and pediatric patients weighing at least 35 kg. Recommended dosage: one tablet once daily, with or without food.

  • Trogarzo* (ibalizumab-uiyk), in combination with other antiretrovirals, for the treatment heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current regimen. Ibalizumab is a monoclonal antibody that prevents HIV fusion and entry into the CD4 cell. Recommended dosage: 2 gm IV loading dose, then 800 mg IV every two weeks.

New FDA Indication

  • Otiprio (ciprofloxacin* 6% otic suspension) for the treatment of acute otitis externa due to P. aeruginosa and S. aureus in patients 6 months of age and older. The product was previously approved for bilateral otitis media with effusion in patients (age 6 months and older) undergoing tympanostomy tube placement. Recommended dosage for acute otitis externa: a single 0.2 mL administration to the external ear canal of each affected ear.

New or Updated Treatment Guidelines

  • Clinical practice guidelines for the diagnosis and treatment of cutaneous leishmaniasis (CL) in Turkey. These guidelines are a consensus text prepared by 18 experienced CL specialists who have been working for many years in areas where the disease is endemic (Int J Dermatol 2018 Apr 16 [Epub ahead of print]).

  • Guidelines for vaccine use in cancer patients, including autologous stem cell transplant recipients, from the Infectious Diseases Working Party (AGIHO) of the German Society for Hematology and Medical Oncology (DGHO) (Ann Oncol 2018 Apr 24 [Epub ahead of print]). the guidelines are available on the journal website.

  • Korean clinical practice guidelines for the antibiotic treatment of community-acquired urinary tract infections (Infect Chemother 50:67, 2018). These guidelines update the 2011 Korean guidelines and are available on the journal website.

  • Updated clinical practice guidelines from the US Public Health Service for the use of pre-exposure prophylaxis (PrEP) to prevent HIV infection, available on the CDC website. They include new information on the safety and efficacy of PrEP, indications for PrEP use, and links to further information. Changes in the updated guidelines are highlighted.

  • 2017 guidelines for HIV pre-exposure prophylaxis (PrEP) from the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine. These guidelines update the 2015 version and represent an adaptation and update of the 2014 US CDC PrEP guidelines (J Virus Erad 4:143, 2018).

From the Centers for Disease Control and Prevention

  • A recently published report compiles and summarizes all recommendations from CDC’s Advisory Committee on Immunization Practices (ACIP) regarding prevention and control of tetanus, diphtheria, and pertussis in the US. As a comprehensive summary of previously published recommendations, this report does not contain any new recommendations and it replaces all previously published reports and policy notes. It is intended for use by clinicians and public health providers as a resource (MMWR 67(2):1-44, 2018).

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • [New on the list]: Gentamicin ophthalmic ointment (unavailable)
    • [Shortage recently resolved]: Ofloxacin 0.3% ophthalmic solution
    • [Continue to be in reduced supply]:
      • Aminoglycosides: Amikacin injection, Tobramycin injection
      • Cephalosporins: Cefepime, Cefotaxime injection (unavailable), Cefoxitin, Cefpodoxime oral suspension, Ceftazidime, Ceftriaxone, Cefuroxime injection (unavailable)
      • Fluoroquinolones: Ciprofloxacin injection, Ciprofloxacin oral suspension, Moxifloxacin injection (unavailable)
      • Penicillins: Amoxicillin/clavulanate 1000 mg/62.5 mg ER tablets, Ampicillin/sulbactam, Oxacillin injection, Penicillin G benzathine/Penicillin G procaine 1.2 million units (Bicillin C-R), Penicillin G procaine injection (unavailable), Piperacillin/tazobactam
      • Other antibacterials: Azithromycin injection, Clindamycin injection, Dalbavancin injection, Doxycycline injection, Erythromycin lactobionate injection (unavailable), Metronidazole injection, Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Vancomycin injection
      • Antifungal drugs: Fluconazole injection
      • Antiparasitic drugs: None
      • Antiviral drugs: Oseltamivir oral suspension
      • Vaccines: Hepatitis A Virus Vaccine Inactivated (Vaqta), Hepatitis B vaccine recombinant, Yellow Fever vaccine (YF-VAX is unavailable, but Stamaril can be obtained through a limited number of clinics in the US. Click here).
  • Antimicrobial drugs newly discontinued: Quinidine gluconate IV (in December 2017). Product distribution will continue until expiration of current stock (March 2019).
    • Recent discontinuations: Terbinafine granules (in May 2017), MenHibrix (in February 2017), Elvitegravir (Vitekta, in December 2016), Peginterferon alfa-2b (in February 2016; 50 mcg vials still available in limited quantities), Boceprevir (in December 2015), Permethrin 1% topical lotion (in September 2015)
  • For detailed information including estimated resupply dates, see http://www.ashp.org/menu/DrugShortages
April 10, 2018

April ID Update

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. Links marked with an asterisk (*) provide details to Web Edition subscribers, while all other links are universal. If you would like to automatically receive our monthly ID Updates by e-mail, subscribe now.

 

April 2018

  

Newly Released Treatment Guidelines

From the Centers for Disease Control and Prevention

  • A yellow fever* outbreak began in Brazil in December 2016. Since January 2018, 10 travel-related cases, including four deaths, have been reported in international travelers returning from Brazil. Eight of the travelers acquired the disease on the island of Ilha Grande, off the Rio de Janeiro coast. All 10 travelers were unvaccinated. Yellow fever vaccination is recommended for all eligible persons aged ≥9 months traveling to many areas of Brazil. YF-VAX, the US FDA-approved vaccine, is currently unavailable; an alternative vaccine not licensed in the US, Stamaril, can be obtained through a limited number of clinics in the US (click here). Vaccination should occur at least 10 days before travel, and recommendations to avoid mosquito bites should be followed (MMWR 67:340, 2018).

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • [New on the list]: Cefpodoxime oral suspension (unavailable)
    • [Shortage recently resolved]: Ofloxacin 0.3% ophthalmic solution
    • [Continue to be in reduced supply]:
      • Aminoglycosides: Amikacin injection, Tobramycin injection
      • Cephalosporins: Cefepime, Cefotaxime injection (unavailable), Cefoxitin, Ceftazidime, Ceftriaxone, Cefuroxime injection (unavailable)
      • Fluoroquinolones: Ciprofloxacin injection, Ciprofloxacin oral suspension, Moxifloxacin injection (unavailable)
      • Penicillins: Amoxicillin/clavulanate 1000 mg/62.5 mg ER tablets, Ampicillin/sulbactam, Oxacillin injection, Penicillin G benzathine/Penicillin G procaine 1.2 million units (Bicillin C-R), Penicillin G procaine injection (unavailable), Piperacillin/tazobactam
      • Other antibacterials: Azithromycin injection, Clindamycin injection, Dalbavancin injection (unavailable), Doxycycline injection, Erythromycin lactobionate injection (unavailable), Metronidazole injection, Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Vancomycin injection
      • Antifungal drugs: Fluconazole injection
      • Antiparasitic drugs: None
      • Antiviral drugs: Oseltamivir oral suspension
      • Vaccines: Hepatitis A Virus Vaccine Inactivated (Vaqta), Hepatitis B vaccine recombinant, Yellow Fever vaccine (unavailable)
  • Antimicrobial drugs newly discontinued: Quinidine gluconate IV (in December 2017). Product distribution will continue until expiration of current stock (March 2019).
    • Recent discontinuations: Terbinafine granules (in May 2017), MenHibrix (in February 2017), Elvitegravir (Vitekta, in December 2016), Peginterferon alfa-2b (in February 2016; 50 mcg vials still available in limited quantities), Boceprevir (in December 2015), Permethrin 1% topical lotion (in September 2015)
  • For detailed information including estimated resupply dates, see http://www.ashp.org/menu/DrugShortages
March 17, 2018

March ID Update

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. Links marked with an asterisk (*) provide details to Web Edition subscribers, while all other links are universal. If you would like to automatically receive our monthly ID Updates by e-mail, subscribe now.
 

MARCH 2018

 

Sanford Guide to Antimicrobial Therapy 2018

  • New print editions of the Sanford Guide to Antimicrobial Therapy are expected to be available within the next two weeks. To learn more about what updates are included or to pre-order books, visit our Online Store.

Drug Safety Communications

  • The US FDA is advising caution when considering the use of clarithromycin* in patients with heart disease because of the potential for increased long-term risk of heart problems or death. This recommendation is based on a review of the results of a 10-year follow-up study of patients with coronary heart disease from a large clinical trial that first observed this safety issue. The full Drug Safety Communication can be found here.

New Generic Approval

Newly Released Treatment Guidelines

Antibiotic Stewardship

  • Fluoroquinolones* (FQ) are associated with serious toxicities, and the US FDA has recently cautioned prescribers to avoid using them if alternative and effective drugs are available. Nevertheless, a recent study suggests that about 5.1% of adult ambulatory FQ prescriptions are written for conditions such as viral URIs and bronchitis that don’t require antibiotics, and 19.9% are for conditions where FQs are not considered firstline choices (sinusitis and uncomplicated UTI). Antibiotic stewardship efforts should be directed against inappropriate FQ use (Clin Infect Dis 2018 Jan 24 [Epub ahead of print]).
  • Carbapenem-resistant Enterobacteriaceae (CRE), such as carbapenem-resistant Klebsiella pneumoniae (CRKP), is associated with limited treatment options and poor outcomes. In addition, resistance to last-line drugs such as colistin is increasing. In the first report of colistin heteroresistance in K. pneumoniae in the US, two multidrug-resistant CRKP urine isolates deemed colistin susceptible by clinical diagnostics were found to harbor a minor colistin-resistant subpopulation. This subpopulation became dominant when grown in the presence of colistin but returned to baseline levels when grown in media free of colistin. To assess possible in vivo relevance, mice infected with either strain did not survive the infection, even in the presence of colistin. This suggests the possibility of patients with colistin-susceptible CRKP strains failing colistin therapy and underscores the importance of improved diagnostics (MBio 9:e02448, 2018).

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • [New on the list]: Ciprofloxacin injection, Dalbavancin injection
    • [Shortage recently resolved]: Ofloxacin 0.3% ophthalmic solution
    • [Continue to be in reduced supply]:
      • Aminoglycosides: Amikacin injection, Tobramycin injection
      • Cephalosporins: Cefepime, Cefotaxime injection (unavailable), Cefoxitin, Ceftazidime, Ceftriaxone, Cefuroxime injection
      • Fluoroquinolones: Ciprofloxacin oral suspension, Moxifloxacin injection
      • Penicillins: Amoxicillin/clavulanate 1000 mg/62.5 mg ER tablets, Ampicillin/sulbactam, Oxacillin injection, Penicillin G benzathine/Penicillin G procaine 1.2 million units (Bicillin C-R), Penicillin G procaine injection (unavailable), Piperacillin/tazobactam
      • Other antibacterials: Azithromycin injection, Clindamycin injection, Doxycycline injection, Erythromycin lactobionate injection (unavailable), Metronidazole injection, Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Vancomycin injection
      • Antifungal drugs: Fluconazole injection
      • Antiparasitic drugs: None
      • Antiviral drugs: Oseltamivir oral suspension
      • Vaccines: Hepatitis A Virus Vaccine Inactivated (Vaqta), Hepatitis B vaccine recombinant, Yellow Fever vaccine (unavailable)
  • Antimicrobial drugs newly discontinued: Quinidine gluconate IV (in December 2017). Product distribution will continue until expiration of current stock (March 2019).
    • Recent discontinuations: Terbinafine granules (in May 2017), MenHibrix (in February 2017), Elvitegravir (Vitekta, in December 2016), Peginterferon alfa-2b (in February 2016; 50 mcg vials still available in limited quantities), Boceprevir (in December 2015), Permethrin 1% topical lotion (in September 2015)
  • For detailed information including estimated resupply dates, see http://www.ashp.org/DrugShortages
February 14, 2018

February ID Update

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. Links marked with an asterisk (*) provide details to Web Edition subscribers, while all other links are universal. If you would like to automatically receive our monthly ID Updates by e-mail, subscribe now.
 

FEBRUARY 2018

New Drug Approvals

  • Biktarvy* (bictegravir, emtricitabine, tenofovir alafenamide) for the treatment of HIV-1 infection in adults with no prior antiretroviral treatment history, or to replace the current regimen in a patient virologically suppressed on a stable regimen for at least three months with no history of treatment failure or known substitutions associated with resistance to bictegravir, emtricitabine, or TAF. Recommended dosage: one tablet once daily, with or without food.
  • Symfi Lo* (efavirenz, lamivudine, tenofovir disoproxil fumarate) for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg. Recommended dosage: one tablet once daily on an empty stomach, preferably at bedtime to improve tolerability of CNS side effects.
  • Firvanq (vancomycin oral solution), indicated for the treatment of C. difficile* associated diarrhea in adults and pediatric patients <18 years of age, and also for the treatment of enterocolitis caused by Staph. aureus (including MRSA) in adults and pediatric patients <18 years of age. Product availability: kits containing vancomycin powder (3.75, 7.5, 10.5, or 15 gm) and grape-flavored diluent that provide final drug concentrations of 25 mg/mL and 50 mg/mL after reconstitution. Expected product launch: early April, 2018.

New FDA-approved Indications

  • Ceftazidime-avibactam* is now indicated for the treatment of hospital-acquired pneumonia and ventilator-associated pneumonia caused by Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae in patients 18 years of age or older. The drug was previously approved for complicated intra-abdominal infection (in combination with metronidazole) and complicated UTI, including pyelonephritis.

From the Centers for Disease Control and Prevention

  • February 9 CDC update on widespread influenza activity, including an audio recording. Click here.
  • Weekly US Influenza Surveillance Report. Click here.
  • The 2018 recommended immunization schedule for children and adolescents aged 18 years or younger. Click here.
  • The 2018 recommended immunization schedule for adults aged 19 or older. Click here.
  • Updated recommendations from the Advisory Committee on Immunization Practices (ACIP) and CDC regarding prevention of hepatitis B infection in the US (MMWR Recomm Rep 67:1, 2018). Available for download here.

Newly Released Treatment Guidelines

  • Clinical guidelines for the diagnosis and treatment of catheter-related bloodstream infection from the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) and the Spanish Society of Spanish Society of Intensive and Critical Care Medicine and Coronary Units (SEMICYUC) (Med Intensiva 42:5, 2018). The last Spanish catheter-related infections guidelines were published in 2004. The new guidelines are available for download on the SEIMC and SEMICYUC websites.
  • 2017 update of the German clinical guideline on epidemiology, diagnostics, therapy, prevention, and management of uncomplicated urinary tract infections in adult patients (Urol Int 2018 Jan 17 [Epub ahead of print]). This is an update of the 2010 version and is available for download on the Karger website.
  • 2017 update of the guideline for epidemiology, diagnosis, and treatment of adult patients with nosocomial pneumonia from the German Society for Anaesthesiology and Intensive Care Medicine, the German Society for Infectious Diseases, the German Society for Hygiene and Microbiology, the German Respiratory Society and the Paul-Ehrlich-Society for Chemotherapy, the German Radiological Society and the Society for Virology (Pneumologie 72:15, 2018). This is an update of the 2012 version.
  • Guidelines for the diagnosis and treatment of community-acquired pneumonia in adults who present to the hospital from the Dutch Working Party on Antibiotic Policy in collaboration with the Dutch Association of Chest Physicians, the Dutch Society for Intensive Care, and the Dutch College of General Practitioners (Neth J Med 76:4, 2018). These guidelines update the 2011 version and are available for download on the journal website.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • [New on the list]: Azithromycin injection, Oseltamivir oral suspension
    • [Shortage recently resolved]: Penicillin G benzathine
    • [Continue to be in reduced supply]:
      • Aminoglycosides: Amikacin injection, Tobramycin injection
      • Cephalosporins: Cefepime, Cefotaxime injection (unavailable), Cefoxitin, Ceftazidime, Ceftriaxone, Cefuroxime injection
      • Fluoroquinolones: Ciprofloxacin oral suspension, Moxifloxacin injection, Ofloxacin 0.3% ophthalmic solution
      • Penicillins: Amoxicillin/clavulanate 1000 mg/62.5 mg ER tablets, Ampicillin/sulbactam, Oxacillin injection, Penicillin G benzathine/Penicillin G procaine 1.2 million units (Bicillin C-R), Penicillin G procaine injection (unavailable), Piperacillin/tazobactam
      • Other antibacterials: Clindamycin injection, Doxycycline injection, Erythromycin lactobionate injection (unavailable), Metronidazole injection, Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Vancomycin injection
      • Antifungal drugs: Fluconazole injection
      • Antiparasitic drugs: None
      • Antiviral drugs: None
      • Vaccines: Hepatitis A Virus Vaccine Inactivated (Vaqta), Hepatitis B vaccine recombinant, Yellow Fever vaccine (unavailable)
  • Antimicrobial drugs newly discontinued: Quinidine gluconate IV (in December 2017). Product distribution will continue until expiration of current stock (March 2019).
    • Recent discontinuations: Terbinafine granules (in May 2017), MenHibrix (in February 2017), Elvitegravir (Vitekta, in December 2016), Peginterferon alfa-2b (in February 2016; 50 mcg vials still available in limited quantities), Boceprevir (in December 2015), Permethrin 1% topical lotion (in September 2015)
  • For detailed information including estimated resupply dates, see http://www.ashp.org/menu/DrugShortages