Nursing & Healthcare News

Updates from the FDA

July 2019

Medicine vs. Mosquitoes

New tools to detect Zika and prevent dengue disease

Do you have patients from areas where mosquito-borne illnesses are endemic? If so, you should know about some important developments in the detection and prevention of Zika virus and dengue.

Dengue Vaccine for Kids Only

The FDA recently approved a vaccine for dengue, a viral infection spread primarily by mosquitoes that affects an estimated 390 million people a year worldwide. However, there are some important provisos you should know.

Dengue is an unusual disease. The virus has four distinct serotypes; first-time infection with any one of these four is rarely severe and usually leaves you immune to that particular serotype. However, if you’re subsequently infected with one of the other three serotypes, you’re at risk of a much more severe dengue infection, which can be lethal.

Back in 2015, Sanofi Pasteur introduced a vaccine, Dengvaxia, specifically designed to prevent severe dengue. Administered to patients who’ve been previously infected with dengue (usually confirmed by antibody tests), the FDA says the three-injection series is about 76 percent effective in preventing subsequent infections.

Although the European Union has approved Dengvaxia for both pediatric and adult patients, the FDA approval covers only kids 9–16, and only in areas where dengue is endemic, which currently means Puerto Rico and some other U.S. territories. The vaccine is NOT for patients who have not been previously infected with dengue.

ZIKA Virus

Although there’ve been no reported cases of local transmission within the U.S. recently, Zika virus (ZIKV) remains a concern because infection in pregnant patients has been linked to microcephaly and other poor outcomes. ZIKV infection is also linked to a serious neurological disease, Guillain-Barré syndrome.

Hiring Now

In May, the FDA approved the first ZIKV diagnostic test to be commercially available in the U.S. Marketed by InBios International, the test detects Zika virus antibodies in a patient’s blood.  At present, the test is approved only for patients who may be infected with Zika virus, not for screening blood donors.

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Fighting Pediatric Hepatitis C

Drug approval extended to children 12–18

There’s a new treatment option for pediatric patients with hepatitis C: The FDA has approved the antiviral drug Mavyret (glecaprevir-pibrentasvir) for children as young as 12.There’s a new treatment option for pediatric patients with hepatitis C: The FDA has approved the antiviral drug Mavyret (glecaprevir-pibrentasvir) for children as young as 12.

Liver Killer

Hepatitis C is a transmissible, blood-borne viral liver infection that can lead to progressive chronic liver disease or liver cancer. Although most often spread by sharing needles, the hepatitis C virus (HCV) can also be transmitted from mother to fetus during pregnancy. The CDC estimates that there may be as many as 46,000 HCV-infected children in the United States.

Back in August 2017, the FDA approved a promising new antiviral medication for treating HCV: tablets of glecaprevir and pibrentasvir, marketed by AbbVie Inc. under the trade name Mavyret. Clinical trials suggest that a full course of Mavyret can completely cure all genotypes of HCV in patients with no or mild cirrhosis.

Although the 2017 approval included only adult patients, the FDA has now extended that approval to include children 12 years or older weighing at least 99 pounds.

Not for Everyone

As with many medications, Mavyret has some contraindications, in particular for those who also have (or have had) hepatitis B. You can learn more about glecaprevir-pibrentasvir in the treatments section of the Hepatitis C Online webpage maintained by the University of Washington at www.hepatitisc.uw.edu.

Nursing Education

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New Treatment for Hospital-Acquired Infections

Drug approved for HABP and VABP

There’s a new tool for fighting hospital-acquired infections: The FDA recently approved the medication Zerbaxa to treat healthcare-associated bacterial pneumonia.

Zerbaxa Approval

If you’ve worked in the ICU, you may be all too familiar with the risks of ventilator-associated bacterial pneumonia (VABP). By some estimates, as many as 27 percent of patients on mechanical ventilators suffer VABP, with typical mortality rates of 10 percent or more. The danger is particularly acute with antibiotic-resistant infections, which are harder to treat.

In June, the FDA granted approval for a new treatment for VABP and other hospital-acquired bacterial pneumonias in adult patients: Zerbaxa, a drug manufactured by Merck that was previously approved for treating complicated intra-abdominal and urinary tract infections.

“Hospital-acquired and ventilator-associated bacterial pneumonia are serious infections that can result in death in some patients,” says FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “New therapies to treat these infections are important to meet patient needs because of increased antimicrobial resistance.”

No Substitute for Hand Hygiene

Although the FDA says Zerbaxa is as safe and effective as existing treatments, the drug still requires careful stewardship to avoid developing resistant bacterial strains. Zerbaxa is also contraindicated in renally impaired patients and can cause severe diarrhea. Ultimately, preventing VABP infections is still just as important as fighting them.

“Nurses are the first line of defense in preventing bacterial colonization of the oropharynx and gastrointestinal tract,” wrote Beth Augustyn, RN, MSN, ACNP, CCRN, in an oft-cited study in the journal Critical Care Nurse, noting that “meticulous” hand hygiene by nurses and other clinicians is a vital step in avoiding cross-contamination and reducing infection risk.


Aaron Severson is a freelance writer, editor, and writing consultant as well as the associate editor of Working Nurse.


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