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  5. Drug Safety Oversight Board Meeting - January 21, 2016
  1. Center for Drug Evaluation and Research | CDER

Drug Safety Oversight Board Meeting - January 21, 2016

Public Summary

The following Drug Safety Communications posted since the September 17, 2015 DSB meeting:

  • September 21, 2015: FDA is evaluating the risks of using the pain medicine tramadol in children aged 17 and younger due to rare but serious risk of slowed or difficult breathing. This risk may be increased in children treated with tramadol for pain after surgery to remove their tonsils and/or adenoids. We are evaluating all available information and will communicate our final conclusions and recommendations to the public when our review is complete.
  • September 22, 2015: FDA is warning health care professionals about the risk for dosing errors with the intravenous antibacterial drug Avycaz (ceftazidime and avibactam) due to confusion about the drug strength displayed on the vial and carton labels. To prevent medication errors, we have revised the labels to indicate that each vial contains Avycaz 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram. 
  • October 22, 2015: FDA is requiring the Kayexalate (sodium polystyrene sulfonate) manufacturer to conduct studies to investigate Kayexalate’s potential to bind to other medications administered by mouth, drug interactions that could affect efficacy of concomitant medications.
  • October 22, 2015: FDA is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. As a result, we are requiring the manufacturer to add new information about this safety risk to the drug labels.
  • October 26, 2015: A FDA safety review has found no clear evidence of an increased risk of heart attacks, stroke, or other cardiovascular events associated with the use of Comtan (entacapone) for the treatment of Parkinson’s disease. As a result, our recommendations for using Comtan and Stalevo (a combination of entacapone, carbidopa, and levodopa) will remain the same in the drug labels. 
  • November 6, 2015: A FDA review has determined that long-term use of the anticoagulant Plavix (clopidogrel) does not increase or decrease overall risk of death in patients with, or at risk for, heart disease. Our evaluation of the Dual Antiplatelet Therapy (DAPT)1 trial and several other clinical trials also does not suggest that clopidogrel increases the risk of cancer or death from cancer. 
  • November 17, 2015: FDA is advising that rare cases of underactive thyroid have been reported in infants following the use of iodinated contrast media (ICM) for X-rays and other medical imaging procedures. In all reported cases, the infants were either premature or had other serious underlying medical conditions. Available evidence leads us to believe this rare occurrence is usually temporary and resolves without treatment or any lasting effects. Safety label changes have been approved for all ICM products to include information about these cases. No changes are recommended for current prescribing, administration, or monitoring practices. Manufacturers of ICM products have been required to conduct a study to investigate this safety issue further.
  • December 4, 2015: A FDA safety review has resulted in adding warnings to the labels of a sodium-glucose cotransporter-2 (SGLT2) inhibitors about the risks of too much acid in the blood and of serious urinary tract infections. 
  • December 6, 2015: FDA is eliminating the REMS for rosiglitazone-containing T2 DM medications (approved as Avandia, Avandamet, Avandaryl, and generics). The REMS is no longer necessary to ensure that the benefits of rosiglitazone medicines outweigh their risks. We required that drug manufacturers provide educational training to health care professionals about the current state of knowledge regarding the heart risks of rosiglitazone medicines. Manufacturers have since fulfilled these requirements. 
  • January 4, 2016: FDA is cautioning that differences in dosing regimens between the two oral formulations of the antifungal Noxafil (posaconazole) have resulted in dosing errors. To help prevent additional errors, the drug labels were revised to indicate that the two oral formulations cannot be directly substituted for each other but require a change in dose. Direct mg for mg substitution of the two formulations can result in drug levels that are lower or higher than needed to effectively treat certain fungal infections. Prescribers should specify the dosage form, strength, and frequency on all prescriptions they write for Noxafil.

The Board heard four presentations:

Fluoroquinolones: Evolving Risk/Benefit Concerns

  • Benefits and Risks of Systemic Fluoroquinolone Drugs (Sumathi Nambiar, MD, MPH, Director, Division of Anti-Infective Products, OND/CDER)
  • Fluoroquinolone-Associated Disability (FQAD) Cases in Patients Being Treated for Uncomplicated Sinusitis, Bronchitis, and/or Urinary Tract Infection (Debra Boxwell, PharmD, Division of Pharmacovigilance II, OSE/CDER)

Impact of Statins on Influenza Vaccine Effectiveness

  • Impact of Statins on Influenza Vaccine Effectiveness: Background and Discussion of a Proposed Collaborative FDA-CMS Study among the U.S. Elderly (Hector Izurieta, MD, MPH and Steven Anderson, PhD, Director, Office of Biostatistics and Epidemiology, CBER)
  • The Effect of Concomitant Statin Use with Influenza Vaccine on the Risk of Developing Influenza in Older-Aged Military Beneficiaries (Lara Bull-Otterson, PhD, Pharmacovigilance Center, Office of the Surgeon General, U. S. Army)

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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