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Drug Safety Oversight Board Meeting - January 18, 2018

The following 7 Drug Safety Communications have posted since the May 18, 2017 DSB meeting.

  • December 20, 2017 (update to April 15, 2011 DSC): FDA review finds no significant increase in risk of serious asthma outcomes with long-acting beta agonists (LABAs) used in combination with inhaled corticosteroids (ICS):
    • FDA review of four large clinical safety trials shows that treating asthma with long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS) does not result in significantly more serious asthma-related side effects than treatment with ICS alone.
    • These trials showed that LABAs, when used with ICS, did not significantly increase the risk of asthma-related hospitalizations, the need to insert a breathing tube known as intubation, or asthma-related deaths, compared to ICS alone.
    • Based on FDA’s review, the Boxed Warning, FDA’s most prominent warning, about asthma-related death has been removed from the drug labels of medicines that contain both an ICS and LABA.
  • December 19, 2017 (update to May 22, 2017 DSC):FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings:
    • FDA is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs.
    • FDA is requiring the following specific changes to the labeling of all GBCAs:
      • A Warning and Precaution
      • Changes related to gadolinium retention in the Adverse Reactions, Pregnancy, Clinical Pharmacology, and Patient Instructions sections
    • FDA is requiring several actions to alert health care professionals and patients about gadolinium retention after an MRI using a GBCA, and actions that can help minimize problems.
      • These include requiring a new patient Medication Guide, providing educational information that every patient will be asked to read before receiving a GBCA.
      • FDA is also requiring manufacturers of GBCAs to conduct human and animal studies to further assess the safety of these contrast agents.
  • November 15, 2017: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric):
    • FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol.
    • Once FDA receives the final results from the manufacturer, they will conduct a comprehensive review and will update the public with any new information.
  • September 21, 2017: FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease:
    • FDA is warning that the liver disease medicine Ocaliva (obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death.
    • The recommended dosing and monitoring for patients on Ocaliva are described in the current drug label.
    • FDA is working with the drug manufacturer, Intercept Pharmaceuticals, to address these safety concerns.
  • September 20, 2017 (update to August 31, 2016 DSC): FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks:
    • FDA is advising that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS).
    • The combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction can outweigh these risks. Careful medication management by health care professionals can reduce these risks.
    • FDA is requiring this information to be added to the buprenorphine and methadone drug labels along with detailed recommendations for minimizing the use of medication-assisted treatment (MAT) drugs and benzodiazepines together.
      • For the methadone products, information about the interaction with benzodiazepines and other CNS depressants will be added to an existing Boxed Warning about the risks of slowed or difficult breathing and death. Expanded guidance will be added to the Warnings and Precautions section on how to manage patients in methadone treatment in Opioid Treatment Programs (OTPs) who are also taking CNS depressants.
      • For the buprenorphine products, an existing statement in the Warnings and Precautions section will be expanded and revised to provide more detailed guidance on managing patients in buprenorphine treatment who are also taking CNS depressants
  • September 6, 2017 (update to October 22, 2015 DSC):FDA recommends separating dosing of potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) from all other oral drugs:
    • A study found that sodium polystyrene sulfonate binds to many commonly prescribed oral medicines, decreasing the absorption and therefore effectiveness of those oral medicines.
    • To reduce this likelihood, FDA recommends separating the dosing of sodium polystyrene sulfonate from other orally administered medicines by at least 3 hours.
    • That time should be increased to 6 hours for patients with gastroparesis or other conditions resulting in delayed emptying of food from the stomach into the small intestine.
    • FDA is updating the sodium polystyrene sulfonate drug labels to include information about this dosing separation.
  • May 22, 2017 (update to July 27, 2015 DSC): FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue
    • Because the FDA identified no evidence to date that gadolinium retention in the brain from any of the GBCAs, including GBCAs associated with higher retention of gadolinium, is harmful, restricting GBCA use is not warranted at this time.
    • FDA will continue to assess the safety of GBCAs and plan to have a public meeting to discuss this issue in the future.
    • To date, the only known adverse health effect related to gadolinium retention is a rare condition called nephrogenic systemic fibrosis (NSF) that occurs in a small subgroup of patients with pre-existing kidney failure.

The Board heard four presentations:

Abuse Potential of Gabapentinoids (Shalini Bansil, Controlled Substance Staff, CDER)

Gabapentinoid Use, Abuse, and Drug-involved Mortality (Alex Secora, Division of Epidemiology II; Richard Swain, Division of Epidemiology I; Laurelle Cascio, Division of Pharmacovigilance, OSE/CDER)

The Social Context of Gabapentinoids: Proposed Research (Paula Rausch, OCOMM/CDER)

Prescription Drug Use Related Software (Evan Wearne, Analyst; Jonas Santiago, Deputy Director, Division of Medical Policy Program, OMP/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.

Page Last Updated: 03/22/2018
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