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Drug Safety Oversight Board Meeting, January 17, 2013

Public Summary

The following are Drug Safety Communications (DSC) posted since the November 15, 2012 meeting and relayed to the Drug Safety Oversight Board (DSB or Board) via memorandum:

  • December 4, 2012: Updated information on 32 mg intravenous Zofran (ondansetron hydrochloride): A DSC update was posted notifying health care professionals that the 32 mg, single intravenous dose of the anti-nausea drug Zofran will no longer be marketed because of the potential for serious cardiac risks. This dose has been removed from the Zofran drug label. FDA is now working with the manufacturers of all 32 mg dose ondansetron injectable products (brand and generic) to voluntarily recall them from the market. These drugs are sold pre-mixed in solutions of either dextrose or sodium chloride in plastic containers. A previous DSC, issued in June 2012, communicated that the 32 mg, single IV dose should be avoided due to the risk of QT interval prolongation, which can lead to Torsades de Pointes.
  • December 6, 2012: Important change to heparin container labels to clearly state the total drug strength: A DSC was posted regarding the revision of the heparin container labels to indicate total strength/total volume, followed by strength/mL. This label change will require manufacturers of Heparin Lock Flush Solution, USP and Heparin Sodium Injection, USP to clearly state the strength of the entire container of the medication followed by how much of the medication is in 1 milliliter (mL).
  • December 12, 2012: Safety review update of Chantix (varenicline) and risk of cardiovascular adverse events: An update to the June, 200 DSC was posted informing the public about the results of a meta-analysis of clinical trials that compared patients who received the smoking cessation drug Chantix to patients who received a placebo. FDA required the manufacturer of Chantix to conduct the meta-analysis to further evaluate the cardiovascular safety of the drug. A higher occurrence of major adverse cardiovascular events was observed in patients using Chantix compared to placebo. These events were uncommon in both the Chantix and placebo groups, and the increased risk was not statistically significant. However, the data were analyzed many different ways and consistently showed a higher occurrence of events in patients using Chantix, which makes it seem more likely that it is related to the drug and not purely a chance finding.
  • December 17, 2012: Xyrem (sodium oxybate): A DSC was posted reminding healthcare professionals and patients that the combined use of Xyrem with alcohol or central nervous system depressant drugs can markedly impair consciousness and may lead to severe breathing problems. The use of alcohol with Xyrem is a new contraindication (FDA warns against combined use) added to the Xyrem label, which already contraindicates its use with insomnia drugs. The use of Xyrem with other CNS depressant drugs such as opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, general anesthetics, and muscle relaxants should generally be avoided.
  • December 19, 2012: Incivek (telaprevir): A DSC was posted informing health care professionals and the public of reports received by FDA of serious skin reactions, some fatal, in patients taking the hepatitis C drug Incivek in combination with the drugs peginterferon alfa and ribavirin. Significantly, some patients died when they continued to receive Incivek combination treatment after developing a worsening, or progressive rash and systemic symptoms (symptoms affecting the entire body). As a result, FDA is adding a boxed warning to the Incivek drug label stating that Incivek combination treatment must be immediately stopped in patients experiencing a rash with systemic symptoms or a progressive severe rash.
  • December 19, 2012: Pradaxa (dabigatran etexilate mesylate): A DSC was posted informing health care professionals and the public that the blood thinner Pradaxa should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves. A clinical trial in Europe (the RE-ALIGN trial)1 was recently stopped because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin. There was also more bleeding after valve surgery in the Pradaxa users than in the warfarin users. Pradaxa is not approved for patients with atrial fibrillation caused by heart valve problems. FDA is requiring a contraindication of Pradaxa in patients with mechanical heart valves.
  • January 10, 2013: FDA requires lower recommended doses for certain drugs containing zolpidem: A DSC was posted notifying the public of new information about zolpidem products (Ambien, Ambien CR, Edluar, and Zolpimist), widely prescribed insomnia drugs. FDA recommends that the bedtime dose be lowered because new data show that blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving. Additionally, FDA has informed the manufacturers that the recommended dose of zolpidem for women should be lowered from 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). FDA also informed the manufacturers that, for men, the labeling should recommend that health care professionals consider prescribing the lower doses―5 mg for immediate-release products and 6.25 mg for extended-release products.

The Board heard three presentations.

Zolpidem DSC

Dr. Laura Pincock and Dr. Sheilyn Huang from CDER’s Office of Communication discussed the recently posted Drug Safety Communication (DSC) for zolpidem-containing insomnia products.

Benefit-Risk Framework

Dr. Sara Eggers, Operations Research Analyst in CDER’s Office of Planning and Analysis presented on the development and implementation of the Benefit-Risk Framework. Update on Mini-Sentinel Dr. Marsha Reichman, Scientific Lead for Surveillance in CDER’s Office of Surveillance and Epidemiology, presented an update on the Mini-Sentinel project within CDER.

Update on Mini-Sentinel

Dr. Marsha Reichman, Scientific Lead for Surveillance in CDER’s Office of Surveillance and Epidemiology, presented an update on the Mini-Sentinel project within CDER.