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  5. Drug Safety Oversight Board Meeting - May 18, 2017
  1. Center for Drug Evaluation and Research (CDER)

Drug Safety Oversight Board Meeting - May 18, 2017

Public Summary

The following four Drug Safety Communications posted since the March 16, 2017 DSB meeting:

  • May 16, 2017: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR). The final results from two clinical trials – the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) – showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo. We are requiring new warnings, including a Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.
  • April 27, 2017: FDA approves label changes for use of general anesthetic and sedation drugs in young children. These changes include: o A new Warning stating that exposure to these medicines for lengthy periods of time or over multiple surgeries or procedures may negatively affect brain development in children younger than three years. o Addition of information to the sections of the labels about pregnancy and pediatric use to describe studies in young animals and pregnant animals that showed exposure to general anesthetic and sedation drugs for ≥3 hours can cause widespread loss of nerve cells in the developing brain. Studies in young animals suggested these changes result in long-term negative effects on the animals’ behavior or learning. 
  • April 20, 2017: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women; several changes to the labels of all prescription medicines containing these drugs were made: o A Contraindication was added to the drug labels of codeine and tramadol alerting that codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12 years. o A new Contraindication to the tramadol label warns against its use in children younger than 18 years to treat pain after surgery to remove tonsils and/or adenoids. o A new Warning to the drug labels of codeine and tramadol recommends against use in adolescents between 12 and 18 years who are obese or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems. o A strengthened Warning to mothers that breastfeeding is not recommended when taking codeine or tramadol medicines due to the risk of serious adverse reactions in breastfed infants which can include excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death. https://www.fda.gov/Drugs/DrugSafety/ucm549679.htm
  • March 15, 2017: FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder: An FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death. We are working with Viberzi manufacturer, Allergan, to address these safety concerns. 

The Board heard three presentations:

Drug Labels and Reimbursement Decisions (Chris Leptak, M.D., Ph.D., Director, Regulatory Science Program, Co-Director, Biomarker Qualification Program, OND/CDER)

Multimodal Analysis of FDA’s Drug Safety Communications (DSCs) (Esther Zhou, M.D., Ph.D, Division of Epidemiology-I, OPE/OSE/CDER)

Drug Safety Labeling Changes (SLCs): Transition from MedWatch to CDER (Mary Kremzner, PharmD, MPH, CAPT, USPHS, Director, Division of Drug Information (DDI) OCOMM/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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