Drug Safety Oversight Board Meeting, May 16, 2013
The following Drug Safety Communications (DSCs) have posted since the March 21, 2013 DSB meeting:
- April 26, 2013: Potiga (ezogabine) – A DSC was issued concerning a finding of blue skin discoloration and eye abnormalities characterized by retinal pigment changes in some patients taking the anti-seizure medication Potiga. FDA does not currently know if these changes are reversible. Patients taking Potiga should have a baseline eye exam followed by periodic eye exams.
- April 30, 2013: Samsca (tolvaptan) – A DSC was issued to notify the public that FDA has determined that the drug Samsca (tolvaptan), a drug used to treat hyponatremia, should not be used for longer than 30 days and should not be used in patients with underlying liver disease because it can cause liver injury, potentially requiring liver transplant or death.
- May 6, 2013: Valproate products – A DSC was issued advising health care professionals and women that the anti-seizure medication valproate sodium and related products, valproic acid and divalproex sodium, are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches. Based on information from a recent study, there is evidence that these medications can cause decreased IQ scores in children whose mothers took them while pregnant. Stronger warnings about use during pregnancy will be added to the drug labels, and valproate’s pregnancy category for migraine use will be changed from "D" (the potential benefit of the drug in pregnant women may be acceptable despite its potential risks) to "X" (the risk of use in pregnant women clearly outweighs any possible benefit of the drug).
- May 6, 2013: Kadcyla (ado-trastuzumab emtansine) – A DSC was issued alerting health care professionals that the use of the incorrect nonproprietary name for the breast cancer drug Kadcyla (ado-trastuzumab emtansine) in some medication-related electronic systems poses a risk of mix-up with Herceptin (trastuzumab) and may result in medication errors. The dosing and treatment schedules for Kadcyla and Herceptin, another breast cancer drug, are quite different, so confusion between these products could lead to dosing errors and potential harm to patients.
- May 14, 2013: Zolpidem products – A DSC update was issued notifying public that FDA has approved label changes specifying new dosing recommendations for zolpidem products (Ambien, Ambien CR, and Edluar), which are widely prescribed sleep medications. FDA has approved these changes because of the known risk of next-morning impairment with these drugs. FDA is also warning that patients who take the sleep medication zolpidem extended release (Ambien CR)―either 6.25 mg or 12.5 mg―should not drive or engage in other activities that require complete mental alertness the day after taking the drug because zolpidem levels can remain high enough the next day to impair these activities. This new recommendation has been added to the Warnings and Precautions section of the physician label and to the patient Medication Guide for zolpidem extended-release (Ambien CR).
The DSB heard three presentations:
FDA Drug Safety Communication (DSC) Program
Laura L. Pincock, PharmD, MPH, Team Lead and Analyst, Safety & Risk Communication Team from CDER’s Office of Communications/Division of Health Communications discussed the CDER Drug Safety Communication (DSC) Program, covering the importance of communicating about drug risk, factors involved in issuing a DSC, including the crucial elements of why and when to communicate publically with a DSC.
Dr. Pincock noted that CDER OCOMM is committed to providing the public with up-to-date drug safety information; to careful consideration of best practices, inherent tensions, and effective mediums when communicating new and emerging drug safety information; to continued improvement of communication effectiveness, and use of research initiatives to evaluate reach and influence on behavior and perception of messaging.
Update on REMS activities
Terry Toigo, Associate Director for Safety Operations in CDER’s Office of the Center Director, presented an update to the Board on current REMS activities. She provided a brief overview of the REMS program since 2008 and highlighted the activities ongoing under the REMS Integration Initiative, particularly efforts to better standardize and evaluate REMS.
REMS experience discussion
Megan Moncur, Office of Surveillance and Epidemiology’s Division of Risk Management (DRISK), and Adam Kroetsch, Office of Program and Strategic Analysis lead a discussion and review of questions concerning REMS that were sent in advance to DSB members with clinical sites. This is part of an ongoing effort by FDA to better integrate REMS into the health care system, to decrease the burden to stakeholders, and to ultimately make REMS more effective. Additionally, FDA hopes to use feedback received today to better inform the internal working groups as they plan for a July 2013 public meeting on REMS standardization and evaluation.