Drug Safety Oversight Board Meeting, March 18, 2010
The Executive Director updated the Drug Safety Oversight Board (DSB or Board) on Drug Safety Communications posted and in development since the February 18, 2010 meeting. The following is a list of the posted risk communications:
Drug Safety Communications Posted since the February 18, 2010 DSB meeting:
- February 18, 2010: New safety requirements for long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs)
- February 22, 2010: Ongoing review of rosiglitazone (Avandia) and cardiovascular safety
- February 23, 2010: Ongoing safety review of saquinavir (Invirase) and possible association with abnormal heart rhythms
- March 10, 2010: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures
- March 12, 2010: Reduced effectiveness of clopidogrel (Plavix) in certain patients known as poor metabolizers
The DSB heard presentations and discussed two topics:
- Opioid REMS for extended-release and long-acting products
- An update on pregnancy registries from FDA’s Pediatric and Maternal Health Staff
The views expressed from non-CDER employees are those of the individual and not necessarily the opinion of their respective government agency.
Opioid REMS for Extended-Release and Long-Acting Products
An opioid drug can be categorized as short-acting or long-acting, and are generally used for the management of pain. Extended-release and long-acting opioids are indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. They are not intended for use as an “as needed” analgesic. Abuse and misuse of the extended-release and long-acting opioid drugs have a huge public health and societal impact. Addressing the opioid problem involves FDA using its Risk Evaluation and Mitigation Strategy (REMS) authority.
The Board discussed various aspects of the proposed REMS for extended-release or long-acting opioids. The Federal Partners with hospitals and clinics presented information on opioid usage patterns and how the proposed opioid REMS for the extended-release and long-acting products might affect their health care providers and patient populations.
The Board discussed the following:
- An overview of the treatment of chronic pain
- The availability, history, and safety issues associated with the extended-release and long-acting opioids
- Extended-release and long acting opioid misuse and abuse data from the National Survey on Drug Use and Health (NSDUH) and Drug Abuse Warning Network (DAWN)
- The goals of the Opioid REMS
- FDA’s preliminary recommendations for the proposed Opioid REMS
- Challenges associated with imposing and implementing the Opioid REMS
- Proposed methods for assessing the effectiveness of the Opioid REMS
- Aspects of the proposed Opioid REMS that are most important to achieving the goal of improved safety
- Aspects of the proposed Opioid REMS that are problematic or may present significant burdens on the health care system and how these areas might be addressed
An Update from FDA’s Pediatric and Maternal Health Staff on Pregnancy Registries
A pregnancy registry is a study that collects health information from women who take medicines and are given vaccines when they are pregnant. Health information is also collected on the newborn infant. This information is compared with women who have not taken medicine during pregnancy. FDA’s Pediatric and Maternal Health Staff provided the Board with a 1-year update on FDA’s progress on implementing pregnancy registries for various medications. Dr. Janet Cragan, from the Centers for Disease Control and Prevention, joined the Board as a guest expert in pregnancy registries.
The Board discussed the following:
- The Vaccine and Pregnancy Medication Surveillance System (VAMPSS), a vaccine and pregnancy registry study
- An overview on the Medication Use in Pregnancy and Birth Outcomes Research Program (MEPREP), its accomplishments, and future directions
- An overview of recently funded AHRQ grants in comparative effectiveness on asthma medications and pregnancy outcomes that came as a result of the DSB meeting in February 2009