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U.S. Department of Health and Human Services

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Drug Safety Oversight Board Meeting, September 16, 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 July 15, 2010 meeting. The following is a list of the posted risk communications:

Drug Safety Communications Posted since the July 15, 2010 DSB meeting:

The DSB discussed three topics:
1. Update on Risk Evaluation and Mitigation Strategies (REMS)
2. Stalevo and cardiovascular safety
3. Update on the Safe Use Initiative

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

Update on Risk Evaluation and Mitigation Strategies (REMS)

A REMS is a required risk management plan that uses risk minimization strategies beyond professional labeling. FDA can require a REMS if they believe it is necessary to ensure that the benefits of a drug outweigh its risks.

FDA was given the authority to require REMS in March 2008 under the Food and Drug Administration Amendments Act. The Office of Surveillance and Epidemiology (OSE) presented the DSB with an update on CDER’s experience with REMS during the past 30 months.

The Board discussed the following:

  • A brief overview of the REMS program
  • The challenges associated with implementing REMS
  • The importance of developing REMS that effectively minimize potential risks of using a drug while imposing the least burden
  • The challenges associated with review of REMS assessments and development of assessment surveys
  • Metrics for REMS assessment and the challenge of determining metrics for success when baseline data are difficult to obtain or are not available
  • The challenge of reducing the burden of REMS on the health care system

Stalevo and Cardiovascular Safety

Stalevo is a triple combination product with entacapone, carbidopa, and levodopa approved in 1999 for the treatment of Parkinson’s disease (PD). Entacapone lacks an anti-Parkinson’s effect on its own, but increases the peripheral and brain levodopa availability. Levodopa relieves some of the symptoms of Parkinson’s disease.

On August 20, 2010, FDA posted a Drug Safety Communication (DSC) to inform healthcare professionals and the public about a possible increased risk of cardiovascular (CV) adverse events with the use of Stalevo. FDA Drug Safety Communication: Ongoing Safety Review of Stalevo and possible increased cardiovascular risk.

Board discussed the DSC and any impact it may have had on healthcare professionals and the public.

The Federal Partners with hospitals and clinics provided Stalevo usage patterns including any information about CV adverse events in their patients using Stalevo. The Board invited a guest expert in cardiovascular studies, Dr. Michael Lauer, from the National Heart Lung and Blood Institute (NHLBI) at the National Institutes of Health (NIH). Dr. Lauer provided a research perspective on the use of Stalevo and the risk of CV adverse events.

The Board discussed the following:

  • A brief overview of the use of Stalevo and its components: entacapone, carbidopa, and levodopa in patients with PD
  • A brief overview of the mechanism of action of entacapone, carbidopa, and levodopa in relieving symptoms of PD
  • The current drug label for Stalevo
  • Clinical data from the STRIDE-PD randomized trial and epidemiologic data reporting an association of CV risk with Stalevo
  • A meta-analysis of 15 clinical trials looking at CV risk with use of Stalevo or its entacapone component.
  • The challenges associated with interpreting the meta-analysis given much of the potential signal for CV risk comes from the STRIDE-PD trial.
  • The August 20, 2010 DSC on Stalevo and CV risk and its main messages
  •  Possible approaches to further evaluating the potential signal for CV risk with Stalevo

Update on the Safe Use Initiative

Safe Use is a FDA initiative to reduce risks from prescription and OTC medications; promote drug safety outside of the usual regulatory authorities, such as REMS or labeling; and form collaborations with health care stakeholders to address preventable harm from a broader perspective.

The priorities for Safe Use are issues that are associated with preventable harm, have an impact on public health, are amenable to a collaborative approach to harm reduction, are measureable, and complement ongoing regulatory activities.

The Board discussed the following:

  • A brief overview of the Safe Use program
  • Current issues being address by the Safe Use team
  • The challenges associated with developing collaborative partnerships
  • Future plans for the Safe Use initiative