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  5. Drug Safety Oversight Board Meeting - September 20, 2018
  1. Center for Drug Evaluation and Research | CDER

Drug Safety Oversight Board Meeting - September 20, 2018

Public Summary

The following 5 Drug Safety Communications have posted since the May 17, 2018 DSB meeting.

  • August 29, 2018: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes
    • This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier’s gangrene. Fournier’s gangrene is an extremely rare but life-threatening bacterial infection of the tissue under the skin that surrounds muscles, nerves, fat, and blood vessels of the perineum.
    • FDA is requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.
  • August 3, 2018: FDA warns about increased risk of cancer relapse with long-term use of azithromycin (Zithromax, Zmax) antibiotic after donor stem cell transplant
    • Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients.
    • FDA is reviewing additional data and will communicate our conclusions and recommendations when our review is complete.
    • The manufacturer of brand name azithromycin is providing a Dear Healthcare Provider letter on this safety issue to health care professionals who care for patients undergoing donor stem cell transplants.
  • July 10, 2018: FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes
    • FDA’s recent review found reports of life-threatening low blood sugar side effects and reports of additional mental health side effects.
    • FDA is requiring these updates in the drug labels and to the patient Medication Guides for the entire class of fluoroquinolones. This affects only the fluoroquinolone formulations taken by mouth or given by injection.
    • The new label changes will make the mental health side effects more prominent and more consistent across the systemic fluoroquinolone drug class. The mental health side effects to be added to or updated across all the fluoroquinolones are disturbances in attention, disorientation, agitation, nervousness, memory impairment, and serious disturbances in mental abilities called delirium.
  • May 23, 2018 (update to April 7, 2011 DSC): Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics
    • Due to the significant safety risk of methemoglobinemia, FDA has urged manufacturers that they should stop marketing OTC oral drug products for treating teething in infants and children younger than 2 years.
    • If companies do not comply, FDA will take action to remove these products from the market. FDA has also urged manufacturers of OTC oral drug products containing benzocaine for adults and children 2 years and older to make the following changes to the labels of their products:
      • Adding a warning about methemoglobinemia;
      • Adding contraindications, FDA’s strongest warnings, directing parents and caregivers not to use the product for teething and not to use in infants and children younger than 2 years; and
      • Revising the directions to direct parents and caregivers not to use the product in infants and children younger than 2 years.
  • May 18, 2018: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)
    • FDA is alerting the public that serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir used to treat human immunodeficiency virus (HIV).
    • Preliminary results from an ongoing observational study in Botswana found that women who received dolutegravir at the time of becoming pregnant or early in the first trimester appear to be at higher risk for these defects.
    • To date, in this observational study there are no reported cases of babies born with neural tube defects to women starting dolutegravir later in pregnancy.

The Board heard two presentations.

Insulin Pen Packaging: Safety Concerns and Possible Revisions (Ashleigh Lowery, PharmD, Division of Medication Error Prevention and Analysis, Office of Surveillance and Epidemiology, CDER)

Febuxostat (Uloric) and the Cardiovascular Safety Data from the Postmarketing Required CARES Study (Rosemarie Neuner, MD, MPH, Division of Pulmonary, Allergy, and Rheumatology Products, Office of New Drugs, CDER)

Views expressed by non-CDER employees are those of the individual and not necessarily the opinion of his/her respective federal agency or institution.

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