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About FDA

Drug Safety Oversight Board Meeting, March 21, 2013

Public Summary

The following Drug Safety Communications (DSCs) have posted since the January 17, 2013 DSB meeting:

  • February 20, 2013: Codeine use in children after tonsillectomy and/or adenoidectomy. A DSC update was posted about new actions taken to address a known safety concern with codeine use in certain children after tonsillectomy and/or adenoidectomy (surgery to remove the tonsils and/or adenoids). Deaths have occurred post-operatively in children with obstructive sleep apnea who received codeine for pain relief following a tonsillectomy and/or adenoidectomy. These children had evidence of being ultra-rapid metabolizers of codeine, an inherited capacity for hepatic conversion of codeine to life-threatening or fatal amounts of morphine. A Boxed Warning will be added to the label of codeine-containing products about the risk of codeine in post-operative pain management in children following tonsillectomy and/or adenoidectomy.
  • February 26, 2013: Pediatric clinical studies of Sensipar (cinacalcet hydrochloride) after death. This DSC notified providers and the public of a clinical hold placed on all pediatric clinical studies of Sensipar (cinacalcet hydrocloride) after the manufacturer, Amgen, suspended the studies after the recent death of a 14-year-old patient in a study. Sensipar is a medication used to decrease the release of parathyroid hormone (PTH) from the parathyroid gland, thereby lowering high PTH levels leading to lower nlood calcium levels. Sensipar is FDA-approved for use in adults but not in children less than 18 years of age, and the clinical studies were underway to determine if the drug is effective and can be used safely in children. Posting this information does not mean that FDA has concluded whether or not Sensipar had a role in the patient’s death; FDA continues to gather information on the circumstances of the patient’s death.
  • March 12, 2013: Azithromycin and the risk of potentially fatal heart rhythms. A DSC was issued warning the public and providers that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. Patients at particular risk for developing this condition include those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal heart rhythms, or arrhythmias. This communication is a result of our review of a study by medical researchers as well as another study by a manufacturer of the drug that assessed the potential for azithromycin to cause abnormal changes in the electrical activity of the heart. Azithromycin drug labels have been updated to strengthen the Warnings and Precautions section. Also relevant to this DSC is an FDA Statement commenting on a recent study published in the New England Journal of Medicine disclaimer icon .
  • March 14, 2013: Possible increased risks of pancreatitis and pre-cancerous findings of the pancreas related to incretin mimetic drugs for type 2 diabetes mellitus (T2DM). FDA is evaluating unpublished new research findings that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pancreatic duct metaplasia in patients with T2DM treated with incretin mimetics (e.g., Byetta, Bydureon, Victoza, Januvia). These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes. FDA continues to evaluate all available data to further understand this potential safety issue. FDA has reached no new conclusions about safety risks with incretin mimetic drugs and will communicate its final conclusions and recommendations when its review is complete. FDA will also participate in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and National Cancer Institute’s (NCI) Workshop on Pancreatitis-Diabetes-Pancreatic Cancer in June 2013 to gather and share additional information.

The DSB discussed six topics, including four brought to the DSB by the Centers for Medicare and Medicaid Services (CMS).

From CMS:

Improving Drug Utilization Review Controls in Part D

Lisa Thorpe and Gary Wirth from CMS’s Medicare Drug Benefit and C&D Data Group (MDBG) presented on CMS efforts to improve drug utilization review controls in Medicare Part D. A comprehensive policy was set forth in a draft and final Call Letter (April 2012), and in more detail in draft (June 2012) and final supplemental guidance (September 2012).

CMS Star Ratings Program

Alice Lee-Martin, PharmD, Division of Clinical and Operational Performance, Medicare Drug Benefit and C&D Data Group offered an overview of the CMS Star Ratings for Medicare Advantage Plans, including development and evolution of the ratings, and measures and data sources used. The Star Ratings permit beneficiaries to compare plans based on quality and performance, and were put in place as part of an effort to both assist beneficiaries in making quality decisions and to make quality data more transparent.

Medicare Part D Medication Therapy Management (MTM) Programs

Michelle Ketcham of CMS’s Division of Clinical & Operational Performance, Medicare Drug Benefit and C&D Data Group presented on the topic of Medication Therapy Management (MTM) in Medicare Part D. She provided an overview of the programs and recent updates from the Affordable Care Act that went into effect on January 1, 2013.

Part D Formulary Review and Formulary Reference File

Brian Martin, Deputy Director of CMS’s DFBO, Medicare Drug Benefit and C&D Data Group, presented on the topic of Part D Formulary Review and the Formulary Reference File, including Part D formulary creation and submission and Part D formulary review checks.

End of CMS Presentations

Biosimilars: Questions and Discussion

Sandra Benton, Murewa Oguntimein, Leah Christl
Office of Medical Policy (OMP), Office of New Drugs, Center for Drug Evaluation & Research

The OMP Biosimilars Team brought discussion questions to the DSB intended to shed light on general understandings of biosimilars among the federal healthcare partners.

FDASIA Section 1138

Dr. Jonca Bull, Director of FDA’s Office of Minority Health, presented on the FDA Safety and Innovation Act, Section 1138, which requires ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups. FDA is required to review and modify, as necessary, its communication plans on the benefits and risks of medical products to inform and educate health care providers and patients with particular focus on underrepresented populations including racial subgroups. To that end, Dr. Bull asked for input from the Board’s federal partners.

Views expressed by non-CDER employees are those of the individual and not necessarily the opinion of their respective federal agency or institution


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