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Drug Safety Oversight Board Meeting, November 21, 2013

Public Summary

The following Drug Safety Communications (DSCs) have posted since the September 19, 2013 DSB meeting:

  • November 20, 2013: FDA warns of rare but serious risk of heart attack and death with cardiac nuclear stress test drugs Lexiscan (regadenoson) and Adenoscan (adenosine). FDA approved drug label changes to reflect these serious events and updated our recommendations for use of these agents.
  • November 13, 2013: FDA requests label changes and single-use packaging for some over-the-counter topical antiseptic products to decrease risk of infection. FDA requested label and packaging changes to enhance the safe use of certain over-the-counter (OTC) topical antiseptic products. This request is the result of our ongoing evaluation of infrequent but continuing reports of infections resulting from antiseptic products labeled for preoperative or preinjection skin preparation. When used properly, topical antiseptics are safe and effective products. However, contamination of topical antiseptics can occur when organisms are introduced into the product(s) by users. Therefore, health care professionals and patients should follow all label directions to decrease the chances of infection. We held a public meeting on Dec. 12, 2012, to gather comments on how to address microbial contamination of antiseptic drug products indicated for preoperative or preinjection skin preparation. The New England Journal of Medicine also published an article we wrote to raise awareness of potential contamination of these products (Chang CY, Furlong L-A. Microbial stowaways in topical antiseptic products. N Engl J Med 2012;367:2170-3).
  • November 6, 2013: Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins. FDA is recommending that health care professionals carefully consider the timing of spinal catheter placement and removal in patients taking anticoagulant drugs, such as enoxaparin, and delay dosing of anticoagulant medications for some time interval after catheter removal to decrease the risk of spinal column bleeding and subsequent paralysis after spinal injections, including epidural procedures and lumbar punctures. These new timing recommendations, which can decrease the risk of epidural or spinal hematoma, will be added to the labels of anticoagulant drugs known as low molecular weight heparins, including Lovenox and generic enoxaparin products and similar products.
  • November 5, 2013: FDA asks manufacturer of the leukemia drug Iclusig (ponatinib) to suspend marketing and sales. (Update to DSC issued on Oct. 11, 2013.) FDA is providing instructions to health care professionals whose patients have been taking Iclusig (ponatinib) and are benefiting from the drug, on how to continue those patients on the drug. We are working closely with Iclusig’s manufacturer, ARIAD Pharmaceuticals (ARIAD), to avoid interruptions in treatment. At this time, Iclusig treatment may be continued for appropriate patients under an emergency Investigational New Drug (IND) application.
  • October 31, 2013: FDA approved label changes for the anti-seizure drug Potiga (ezogabine), describing risk of retinal abnormalities, potential vision loss, and skin discoloration. FDA approved changes to the drug label of the anti-seizure drug Potiga (ezogabine), underscoring risks of abnormalities to the retina in the eye, potential vision loss, and skin discoloration, all of which may become permanent. The revised label includes a new boxed warning due to the risk of abnormalities to the retina. Potiga use should be limited to patients who have not responded adequately to several alternative therapies to decrease the frequency of seizures, and for whom the benefits of treatment outweigh the risks. (These risks were previously described in a DSC in April 2013.) FDA is working on modifying the current Risk Evaluation and Mitigation Strategy (REMS) for Potiga to address the risk of retinal pigmentary abnormalities, potential vision loss, and skin discoloration.
  • September 27, 2013: FDA warns of increased risk of death with IV antibacterial Tygacil (tigecycline) and approves new Boxed Warning. FDA is warning that an additional analysis shows an increased risk of death when intravenous Tygacil (tigecycline) is used for FDA-approved uses as well as for non-approved uses. As a result, we approved a new Boxed Warning about this risk to be added to the Tygacil drug label and updated the Warnings and Precautions and the Adverse Reactions sections. These changes to the Tygacil label are based on an additional analysis that was conducted for FDA-approved uses after issuing a DSC about this safety concern in September 2010.
  • September 25, 2013: Boxed Warning and new recommendations to decrease risk of hepatitis B reactivation with the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab). FDA has approved changes to the prescribing information of the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab) to add new Boxed Warning information about the risk of reactivation of hepatitis B virus (HBV) infection. The revised labels also will include additional recommendations for screening, monitoring, and managing patients on these drugs to decrease this risk. Both Arzerra and Rituxan are used to treat certain cancers of the blood and lymph system. Rituxan is also approved to treat other medical conditions, including rheumatoid arthritis.
  • Sept. 23, 2013: FDA requiring color changes to Duragesic (fentanyl) pain patches to aid safety―emphasizing that accidental exposure to used patches can cause death. FDA is requiring color changes to the writing on Duragesic (fentanyl) pain patches so they can be seen more easily. This is part of an effort to prevent accidental exposure to the patches, which can cause serious harm and death in children, pets, and others. Similar changes are being requested for the generic fentanyl patches. We are also reminding patients and health care professionals that fentanyl patches are dangerous even after they’ve been used because they still contain high amounts of strong narcotic pain medicine. Used fentanyl patches require proper disposal after use―fold the patch, sticky sides together, and flush it down the toilet right away.

The DSB discussed two topics:

Update on the DSB Evaluation Project: Kim Taylor and Manju Thomas of CDER’s Office of Strategic Programs presented results from a recent DSB survey assessing Board structure, roles and responsibilities, and statutory requirements.

Challenges in National Abuse Surveillance Capabilities: Cynthia Kornegay of CDER’s Office of Surveillance and Epidemiology, and Margaret Warner and Linda McCaig of CDC’s National Center for Health Statistics presented. The Board heard a summary of current prescription opioid abuse surveillance data sources and challenges (Cynthia Kornegay), a discussion of mortality assessment related to specific prescription opioids (Margaret Warner), and an update on the Drug Abuse Warning Network Data Collection enterprise through the National Hospital Care Survey (Linda McCaig).

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

Page Last Updated: 12/11/2014
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