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Drug Safety Oversight Board Meeting, February 17, 2011

Public Summary

The Executive Director updated the Drug Safety Oversight Board (DSB or Board) on Drug Safety Communications posted and in development since the January 20, 2011 meeting. The following is a list of the posted risk communications:

Drug Safety Communications Posted since the January 20, 2011 DSB meeting:

In addition to describing the cardiovascular risks, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:

  • In patients already being treated with these medicines
  • In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).
  • February 17, 2011: New warnings against use of terbutaline to treat preterm labor: FDA issued a DSC warning the public that injectable terbutaline should not be used in pregnant women for prevention or prolonged treatment (beyond 48-72 hours) of preterm labor in either the hospital or outpatient setting because of the potential for serious maternal heart problems and death. The FDA is requiring the addition of a Boxed Warning and Contraindication to the terbutaline injection label to warn against this use. In addition, oral terbutaline should not be used for prevention or any treatment of preterm labor because it has not been shown to be effective and has similar safety concerns. The agency is requiring the addition of a Boxed Warning and Contraindication to the terbutaline tablet label to warn against this use.

The DSB discussed two topics:
1. Glass Lamellae in Parenteral Drug Products
2. Update on Communicating Drug Safety Information

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

Glass Lamellae in Parenteral Drug Products

The Board invited a guest expert, Michael N. Eakins, Ph.D., Vice-Chair (volunteer) of the USP’s Packaging, Storage and Distribution Expert Committee (2010 – 2015). Dr. Eakins has published extensively in the field of glass syringes and containers. He provided background and detailed information on the topic of glass lamellae.

The Board discussed the following regarding glass lamellae in parenteral drug products:

  • General background information regarding glass composition and the processes used to manufacture glass vials
  • Risk factors that can predispose glass to delamination
  • Potential mechanisms that can lead to glass delamination
  • Pharmacopeial tests used to assess glass quality
  • FDA initiatives to address the issue, including the Inter-Center Lamellae Working Group
  • A recent voluntary recall involving glass lamellae in a parenteral drug product
  • Clinical perspective including the theoretical risks associated with glass lamellae in drug products
  • Use of FDA’s Drug Quality Reporting System (DQRS) and Adverse Event Reporting System (AERS) in assessing the safety issue
  • Use of nonclinical studies to assess the toxicity of glass lamellae in liquid dosage forms
  • Drug shortage considerations when planning and executing recall actions

Update on Drug Safety Communications

The Board invited a guest expert in risk communication, Dr. Baruch Fischhoff, from Carnegie Mellon University. Dr. Fischhoff is the Howard Heinz University Professor in the departments of Social and Decision Sciences and of Engineering and Public Policy. He also chairs the Food and Drug Administration Risk Communication Advisory Committee. Dr. Fischhoff had previously attended the January 2010 DSB meeting and discussed risk communications with the board. Now, he presented an updated approach to effective risk communication and joined in the discussions about the science of risk communication and how to design a good risk communication using behavioral principles. He discussed an approach to communicating safety science and safety policy in the same communication and how to provide audiences with critical knowledge in comprehensible, accessible terms.

The Board discussed the following regarding Drug Safety Communications:

  • The current single document structure of CDER’s Drug Safety Communications (DSCs), and how well this format serves healthcare professionals and the public
  • Examples of DSCs with high impact in the healthcare arena
  • The role of social media in disseminating the messages in drug safety communications
  • The role of FDA’s Office of Special Health Issues in helping to target dissemination of the information in DSCs
  • The factors related to stability or integrity of the information in DSCs as outside media disseminate the DSC
  • The role of research in helping to design how to communicate drug risk information in a manner best understood by healthcare professionals and the public
  • Communication best practices from other Federal Partner Agencies represented on the DSB