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U.S. Department of Health and Human Services

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Drug Safety Oversight Board Meeting, October 21, 2010

Public Summary

The Executive Director updated the Drug Safety Oversight Board (DSB or Board) on Drug Safety Communications posted and in development since the September 16, 2010 meeting. The following is a list of the posted risk communications:

Drug Safety Communications Posted since the September 16, 2010 DSB meeting:

  • September 17, 2010: Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure: FDA issued a DSC to inform healthcare professionals and the public that it is reviewing data from an ongoing, ten-year epidemiological study designed to evaluate whether Actos (pioglitazone), is associated with an increased risk of bladder cancer. Findings from studies in animals and humans suggest this is a potential safety risk that needs further study.
  • October 8, 2010: FDA Recommends Against the Continued Use of Meridia: FDA issued a DSC to inform healthcare professionals and the public that it requested that the manufacturer of Meridia voluntarily withdraw this drug product from the United States market because the drug may pose unnecessary cardiovascular risks to patients. Abbott has agreed to voluntarily stop marketing of Meridia in the United States. FDA’s recommendation is based on new data from the Sibutramine Cardiovascular Outcomes (SCOUT) trial, which demonstrated a 16% increase in risk of major adverse cardiovascular events in patients treated with Meridia compared to patients taking a placebo. At the end of the trial, patients in the Meridia group lost a small amount of body weight compared to patients in the placebo group.
  • October 13, 2010: Risk of atypical subtrochanteric and diaphyseal femur fractures in patients taking bisphosphonates for osteoporosis: FDA issued a DSC to update healthcare professionals and the public regarding previously communicated information describing the risk of atypical subtrochanteric and diaphyseal femur fractures in patients who take bisphosphonates for osteoporosis. This information will be added to the Warnings and Precautions section of the labels of all bisphosphonate drugs approved for the prevention or treatment of osteoporosis. A Medication Guide, which describes the symptoms of atypical femur fractures and recommends that patients notify their healthcare professional if they develop symptoms, will also be required.
  • October 20, 2010: GnRH agonists and increased risk of diabetes and certain cardiovascular diseases: FDA issued a DSC to update healthcare professionals and the public about previously communicated information regarding gonadotropin-releasing hormone (GnRH) agonists and increased risk of diabetes and certain cardiovascular diseases and has notified the manufacturers of the GnRH agonists of the need to add new safety information to the Warnings and Precautions section of the drug labels. This new information warns about increased risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke) in men receiving these medications for the treatment of prostate cancer.

The DSB discussed four topics:
1. Update on the Sentinel Initiative
2. Patient Medication Information (PMI)
3. Glass Syringes and Risk of Adverse Events Due to Incompatibility with Needleless IV Connectors
4. Qualaquin (quinine sulfate) DSC

The views expressed by non-CDER employees are those of the individual and not necessarily the opinion of their respective government agency.

Update on the Sentinel Initiative

Sentinel is a system for using automated healthcare data for postmarket risk identification and analysis. The goals of Sentinel are to improve FDA’s capability to identify and evaluate safety issues in near real-time, and to enhance FDA’s ability to evaluate safety issues not easily evaluated with passive surveillance systems.

The FDA Amendments Act of 2007 mandated that FDA create an active surveillance system such as Sentinel. Sentinel’s scientific lead presented the DSB with an update on some of the activities that have taken place during the past year under the Sentinel Initiative.

The Board discussed the following:

  • An overview of the Sentinel Initiative
  • The process being used to develop the eventual Sentinel System
  • An overview of the active surveillance system pilot, Mini-Sentinel, including its current status and plans for the upcoming year
  • A brief overview of the Federal Partners Collaboration
  • A brief overview of the Convener on Active Medical Product Surveillance
  • International initiatives related to active medical product surveillance
  • A brief overview of the Observational Medical Outcomes Partnership (OMOP)
  • Challenges associated with development and implementation of Sentinel

Patient Medication Information

Patient Medication Information (PMI) refers to the drug label and all accompanying printed material patients receive with their medication. Examples of this material include a patient package insert (PPI), printed material on the drug container, other consumer medication information including leaflets or pamphlets developed by the private sector, and Medication Guides.

The Board heard a presentation and subsequent discussion from the Office of Medical Policy in the Center of Drug Evaluation and Research about FDA’s current approach to PMI and potential plans for the future.

The Board invited a guest expert in Patient Medication Information, CDR Chris Lamer, from the Indian Health Service (IHS). Dr. Lamer provided background on the medical delivery system in the IHS and a perspective on its use of PMI. The IHS provides medical care to 1.9 Million American Indian and Alaskan Natives in about 550 Federally Recognized Tribes located in 36 States. For tracking the healthcare of its population, the IHS utilizes a Resource and Patient Management System, which includes PMI. This system uses an Electronic Medical Record and draws from printed and online information, including Patient Handouts (e.g. Quit Smoking Guides) and First Databank Medication sheets.

The Board discussed the following:

  • An overview of Patient Medication Information, including a history of its development from 1968-2010
  • The goals of PMI: to provide accurate and reliable written patient information for consumers, patients, health care providers, and policy makers
  • Current issues with PMI being addressed by FDA, including the challenges associated with assessing usefulness of current PMI and evaluating material from multiple sources of PMI
  •  Future plans and directions for PMI, including the possible concept of a single-document solution
  • The use of the electronic medical record and how it relates to PMI in the Indian Health Service
  • Best practices on PMI in the Indian Health Service
  • How the FDA initiative on development of PMI could potentially affect the Indian Health Service and other Federal Partners

Prefilled Glass Syringes and Risk of Adverse Events Due to Incompatibility with Needleless IV Connectors

Certain prefilled glass syringes with needleless connector tips do not reliably fit other devices (such as needleless connectors, luer locks, or needle hubs) potentially causing the glass tip of the syringe to break the needleless connector. This results in the drug or biological product not being delivered properly. FDA has received reports of clogging, malfunction, and breakage of the syringe tip or IV connector, which affects delivery of the medication.

The Board discussed the following:

  • An overview of the safety issue
  • Previous actions to address this issue
  • MedWatch reports received by FDA
  • Scope of the current safety issue
  •  Possible actions to resolve the safety issue

Qualaquin (quinine sulfate)

The Board discussed the DSC for Qualaquin that was issued on July 8, 2010, and how this DSC may affect prescribing of quinine sulfate in the U.S.: FDA Drug Safety Communication: New risk management plan and patient Medication Guide for Qualaquin (quinine sulfate)