Concerns raised about fluoroquinolone use in New Zealand
Scientists in New Zealand are calling for tighter restrictions on the use of fluoroquinolones, according to reporting by the New Zealand Herald.
New Zealand's Pharmaceutical Management Agency, known as Pharmac, has a list of approved conditions that fluoroquinolones should be used for, but the paper reports that documents obtained from each of the country's 20 District Health Boards reveal that in several hospitals, the drugs have been given to patients with conditions other than those specified by Pharmac. In addition, prescriptions for fluoroquinolone eye drops, which are recommended for cornea infections and sometimes used to treat middle ear infections, have increased by more than 300%.
In May 2017, according to the paper, an infectious disease physician and a pharmacist wrote a letter to Pharmac asking the agency for a change in classification that would require physicians to get approval from an infectious disease specialist or microbiologist before using ciprofloxacin. In their letter, they cited the fact that ciprofloxacin use had increased significantly in New Zealand from 2006 to 2014, and during that time resistance to the drug had likewise increased. Pharmac has not yet announced any plans to restrict use of the drug.
Microbiologists are also concerned about potential side effects, such as nerve damage and tendon ruptures. The Herald reports that the New Zealand Centre for Adverse Reaction Monitoring has received 445 reports of suspected negative reactions to fluoroquinolones since 2007, including 64 cases of tendonitis and 24 tendon ruptures.
According to the Best Practice Advocacy Centre for New Zealand, a non-profit that advocates for best practices in healthcare treatments, ciprofloxacin should be reserved for use in acute pyelonephritis, traveler's diarrhea, gonorrhea, severe foodborne disease caused by Campylobacter or Salmonella, bone and joint infections, and invasive Pseudomonas infections—but only when no other options are available.
Jan 3 New Zealand Herald story
FDA to fast-track new drug application for plazomicin
Biopharmaceutical company Achaogen yesterday announced that the US Food and Drug Administration (FDA) will review the company's New Drug Application (NDA) for plazomicin, an antibiotic for the treatment of complicated urinary tract infections (cUTIs) and bloodstream infections caused by multidrug-resistant (MDR) gram-negative pathogens.
According to a company press release, the FDA has given the drug Priority Review designation, a fast-tract review awarded to drugs that would be a significant improvement over current therapy or provide a treatment where none currently exists. The FDA has set a target action date of Jun 25.
Plazomicin was developed to treat serious bacterial infections caused by MDR pathogens, including extended-spectrum beta-lactamase (ESBL)-producing and carbapenem-resistant Enterobacteriaceae (CRE) and has been evaluated in two phase 3 clinical trials, EPIC and CARE. In the EPIC trial, plazomicin met the objective of non-inferiority compared with meropenem in patients with cUTI and acute pyelonephritis. In the CARE trial, patients with serious CRE infections receiving plazomicin had a lower rate of mortality and serious disease-related complications compared with those given colistin. The drug was well-tolerated in both trials.
"The number of confirmed cases of CRE annually in the U.S. is at least 70,000, and is projected to double by 2022," Blake Wise, Achaogen's Chief Executive Officer, said in the press release. "We are excited about plazomicin's potential to address certain multi-drug resistant gram-negative infections and feel that plazomicin would be a valuable new treatment option for patients with serious bacterial infections, including those due to CRE and ESBL-producing Enterobacteriaceae."
Jan 2 Achaogen press release
Dec 12, 2016, Achaogen press release on phase 3 results