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  • FDA Drug Updates

    FDA New Approvals


    The FDA has approved Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epilepsy. Aptiom is approved for the treatment of partial seizures, the most common type of seizure seen in people with epilepsy. Like other antiepileptic drugs, Aptiom may cause suicidal thoughts or actions in a very small number of people. Aptiom is being approved with a Medication Guide that provides patients with important information about the medication that can help patients avoid serious adverse events. The guide will be distributed each time a patient fills their prescription. Aptiom is marketed by Sunovion Pharmaceuticals Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm374358.htm

    Gene Sequencing Devices

    The FDA has allowed marketing of four diagnostic devices that can be used for high throughput gene sequencing, often referred to as "next generation sequencing." Two of the newly cleared devices are used to detect DNA changes in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, which can result in cystic fibrosis. The cleared devices include the Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay, which checks specific points in the patient’s CFTR gene sequence to detect known variants in the gene, and the Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay, which sequences a large portion of the CFTR gene to detect any difference in the CFTR gene compared with a reference CFTR gene. The FDA also granted de novo petitions for the Illumina MiSeqDx instrument platform and the Illumina Universal Kit reagents, two devices that make up the first FDA-regulated test system that allows laboratories to develop and validate sequencing of any part of a patient’s genome. Illumina MiSeqDx instrument platform, Universal Kit reagents, MiSeqDx Cystic Fibrosis 139-Variant Assay, and MiSeqDx Cystic Fibrosis Clinical Sequencing Assay are manufactured by Illumina, Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm375742.htm


    The FDA has approved Imbruvica (ibrutinib) to treat patients with mantle cell lymphoma (MCL). Imbruvica is intended for patients with MCL who have received at least one prior therapy. It works by inhibiting the enzyme needed by the cancer to multiply and spread. Imbruvica is the second drug with breakthrough therapy designation to receive FDA approval. Imbruvica is co-marketed by Pharmacyclics and Janssen Biotech, Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm374761.htm

    Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

    The FDA has approved the first adjuvanted vaccine for the prevention of H5N1 influenza, commonly known as avian or bird flu. The vaccine, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, is for use in people 18 years of age and older who are at increased risk of exposure to the H5N1 influenza virus. The H5N1 avian influenza vaccine is not intended for commercial availability. The U.S. Department of Health and Human Services has purchased the vaccine from the manufacturer, ID Biomedical Corporation of Quebec, Quebec City, Canada (a subsidiary of GlaxoSmithKline Biologicals), for inclusion within the National Stockpile for distribution by public health officials if needed. The vaccine is administered via intramuscular injection in two doses, 21 days apart. The manufacturer will collaborate with the FDA and other U.S. governmental agencies on plans to collect additional safety and effectiveness data through U.S. government-sponsored studies of the vaccine, in the event that it is used during an H5N1 influenza virus pandemic.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm376444.htm


    Valeant Pharmaceuticals International, Inc. has announced that its wholly owned subsidiary, Valeant Pharmaceuticals North America LLC, has received notice that the New Drug Application for Luzu (luliconazole) Cream, 1% has been approved by the FDA. Luzu Cream, 1% is indicated for the topical treatment of athlete's foot (interdigital tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis), caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients 18 years of age and older.
    For more information, visit: http://ir.valeant.com/investor-relations/news-releases/news-release-details/2013/Valeant-Pharmaceuticals-Announces-US-Approval-Of-Luzu-Cream-1/default.aspx


    Merck has announced that the FDA has approved Noxafil (posaconazole) 100 mg delayed-release tablets. Noxafil delayed-release tablets are a new formulation with a loading dose of 300 mg (three 100 mg delayed-release tablets) twice daily on the first day, followed by a once-daily maintenance dose of 300 mg (three 100 mg delayed-release tablets) starting on the second day of therapy. Noxafil delayed-release tablets and oral suspension are indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant recipients with graft-versus-host disease or those with hematologic malignancies with prolonged neutropenia from chemotherapy.
    For more information, visit: www.mercknewsroom.com/news-release/research-and-development-news/fda-approves-mercks-noxafil-posaconazole-delayed-release-


    The FDA has approved Olysio (simeprevir), a new therapy to treat chronic hepatitis C virus infection. Olysio is a protease inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate. It is to be used as a component of a combination antiviral treatment regimen. Olysio is intended for adults with compensated liver disease, including cirrhosis, who have not received treatment for their infection (treatment naive) or for whom previous treatment has not been effective (treatment experienced). Olysio was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that, if approved, would provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to available therapies. Olysio is marketed by Janssen Pharmaceuticals.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm376449.htm

    RNS Stimulator

    The FDA has approved a device to help reduce the frequency of seizures in epilepsy patients who have not responded well to medications. The RNS Stimulator consists of a small neurostimulator implanted within the skull under the scalp. The neurostimulator is connected to one or two wires (called electrodes) that are placed where the seizures are suspected to originate within the brain or on the surface of the brain. Patients with RNS Stimulators cannot undergo magnetic resonance imaging procedures, nor can they undergo diathermy procedures, electroconvulsive therapy, or transcranial magnetic stimulation. The energy created from these procedures can be sent through the neurostimulator and cause permanent brain damage, even if the device is turned off. The RNS Stimulator is manufactured by Neuropace, Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm375041.htm


    BTG plc has announced that the FDA has approved Varithena (polidocanol injectable foam) for the treatment of patients with incompetent veins and visible varicosities of the great saphenous vein system. Varithena (formerly known as Varisolve PEM) is a pharmaceutical-grade, low-nitrogen, polidocanol foam dispensed from a proprietary canister device.
    For more information, visit: www.btgplc.com/page/23741/btg-plc-fda-approves-varithena8482-polidocanol-injectable-foam-for-the-treatment-of-patients-with-varicose-veins


    Velphoro (sucroferric oxyhydroxide) has received FDA approval for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis. Velphoro (previously known as PA21) is an iron-based, calcium-free, chewable phosphate binder. Velphoro was developed by Vifor Pharma. In 2011, all rights were transferred to Vifor Fresenius Medical Care Renal Pharma, a common company of Galenica and Fresenius Medical Care. In the U.S., Velphoro will be marketed by Fresenius Medical Care North America. Velphoro will be launched in the U.S. by Fresenius Medical Care North America in 2014.
    For more information, visit: www.viforpharma.com/en/Media/mediareleases/2013/20131128_velphoro-us.php

    FDA New Indications


    The FDA has expanded the approved uses of Nexavar (sorafenib) to treat late-stage (metastatic) differentiated thyroid cancer. The drug’s new use is intended for patients with locally recurrent or metastatic, progressive differentiated thyroid cancer that no longer responds to radioactive iodine treatment. The FDA completed its review of Nexavar’s new indication under its priority review program. This program provides for an expedited, six-month review for drugs that may offer a significant improvement in safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition. Nexavar also received orphan-product designation by the FDA because it is intended to treat a rare disease or condition. Nexavar is co-marketed by Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm376443.htm


    On November 20, 2013, the FDA granted regular approval for Xalkori (crizotinib) capsules for the treatment of patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive, as detected by an FDA-approved test. Xalkori is marketed by Pfizer, Inc.
    For more information, visit: www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm376058.htm

    FDA First Time Generic Approvals


    The FDA has approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease in adults and adolescents (ages 12 and up). Dr. Reddy’s Laboratories Ltd., Kremers Urban Pharmaceuticals Inc., Lupin Pharmaceuticals Inc., Mylan Pharmaceuticals Inc., Teva Pharmaceuticals USA, and Torrent Pharmaceuticals Ltd. have received FDA approval to market generic rabeprazole.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm374329.htm

    Solaraze Gel

    Impax Laboratories, Inc. and TOLMAR, Inc. have announced that the FDA has granted final approval of TOLMAR’s Abbreviated New Drug Application (ANDA) for its generic version of Solaraze Gel (diclofenac sodium-3%). TOLMAR was the first company to file a substantially complete ANDA containing a Paragraph IV certification, and Impax’s generics division, Global Pharmaceuticals, intends to commercialize this first-to-file product shortly. The last Orange Book listed patent expires August 11, 2015.
    For more information, visit: http://investors.impaxlabs.com/Media-Center/Press-Releases/Press-Release-Details/2013/Impax-Laboratories-and-TOLMAR-Inc-Announce-Final-FDA-Approval-for-Generic-Solaraze-Gel-Diclofenac-Sodium-3/default.aspx

    FDA Labeling Change

    Lexiscan and Adenoscan

    The FDA is warning healthcare professionals of the rare but serious risk of heart attack and death with use of the cardiac nuclear stress test agents Lexiscan (regadenoson) and Adenoscan (adenosine). The FDA has approved changes to the drug labels to reflect these serious events and updated their recommendations for use of these agents. Healthcare professionals should avoid using these drugs in patients with signs or symptoms of unstable angina or cardiovascular instability, as these patients may be at greater risk for serious cardiovascular adverse reactions. Lexiscan and Adenoscan help identify coronary artery disease. They do this by dilating the arteries of the heart and increasing blood flow to help identify blocks or obstructions in the heart’s arteries. Lexiscan and Adenoscan cause blood to flow preferentially to the healthier, unblocked or unobstructed arteries, which can reduce blood flow in the obstructed artery. In some cases, this reduced blood flow can lead to a heart attack, which can be fatal. The Warnings & Precautions section of the Lexiscan and Adenoscan labels previously contained information about the possible risk of heart attack and death with use of these drugs. However, recent reports of serious adverse events in the FDA Adverse Event Reporting System database and the medical literature prompted the FDA to approve changes to the drug labels to include updated recommendations for use. Some events occurred in patients with signs or symptoms of acute myocardial ischemia, such as unstable angina or cardiovascular instability. Cardiac resuscitation equipment and trained staff should be available before administering Lexiscan or Adenoscan. At this time, data limitations prevent the FDA from determining if there is a difference in risk of heart attack or death between Lexiscan and Adenoscan.
    For more information, visit: www.fda.gov/Drugs/DrugSafety/ucm375654.htm

    FDA Recalls

    Atossa Genetics Mammary Aspiration Specimen Cytology Test (MASCT) System Kit and the ForeCYTE Breast Health Test

    The MASCT System Kits and ForeCYTE Breast Health Tests are being recalled by Atossa Genetics due to concerns raised by the FDA in a warning letter sent to the company in February 2013. The FDA raised concerns about (1) the current instructions for use for the MASCT System Kit; (2) certain promotional claims used to market these devices; (3) the requirement that the FDA clear certain changes made to the process of collecting fluid from the nipples; and (4) the requirement that the FDA approve/clear the ForeCYTE Breast Health Test. These devices have not been cleared by the FDA for the screening or diagnosis of breast cancer. If they are used for these purposes as marketed by the firm, women may choose to forgo recommended mammograms and necessary biopsies, and may experience serious adverse health consequences. These include false positive test results, which indicate the presence of breast cancer when none exists, and false negative test results, which indicate the absence of breast cancer when the cancer exists. False positive results may lead to needless patient anxiety, along with further testing and treatment that are not necessary. False negative results may lead to delayed diagnosis and/or delayed treatment of breast cancer, with increased risk of death.
    For more information, visit: www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm374600.htm

    EMBOL-X Glide Protection System

    The FDA has notified healthcare professionals that Edwards Lifesciences LLC has issued a Class I Recall of the EMBOL-X Glide Protection System. The tip of the catheter is being recalled due to a deformed cannula tip. When force is applied to the tip during insertion or removal, it may lead to a separation and embolize. Use of this recalled product may cause serious adverse health consequences, including death. This recall includes model numbers EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D, and EXGF24XL2D. Edwards Lifesciences is recalling all lot numbers of the EMBOL-X Glide Protection System Cannulae that have not expired.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm373549.htm

    FreeStyle and FreeStyle Lite Blood Glucose Test Strips

    Abbott has announced that it is initiating a voluntary recall of 20 lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips in the U.S. These lots of test strips may produce erroneously low blood glucose results when used with both "FreeStyle Blood Glucose Meter" and "FreeStyle Flash Blood Glucose Meter" (neither of which have been in production since 2010), as well as the OmniPod Insulin Management System. When the test strips are used with the newer FreeStyle brand meters including FreeStyle Freedom Blood Glucose Meter, FreeStyle Lite Blood Glucose Meter, and FreeStyle Freedom Lite Blood Glucose Meter, the blood glucose test results are not affected. Testing with the FreeStyle InsuLinx Blood Glucose Meter is not affected by this action, as FreeStyle InsuLinx Blood Glucose Meter uses FreeStyle InsuLinx test strips. The affected test strips are from lots that hold expiration dates from between May 2014 and March 2015.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm376975.htm

    GemStar Infusion System

    The GemStar Infusion System is a small, lightweight, single-channeled device designed for use in the home, hospital, or anywhere electronic infusion is required. The device is intended for use in intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional foods, and blood/blood products. The proximal and distal pressure sensor calibration can drift, resulting in the pump failing the Proximal or Distal Occlusion Operational Test or resulting in an error being reported during device setup or infusion. A pump with this issue may, instead of reporting an error, not detect occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user. This issue may also result in the pump shutting down. Potential risks include a delay/interruption in therapy or over-infusion, which have a worst case potential to result in significant injury or death. All GemStar Infusion Pumps (Models 13000, 13100, 13150, 13086, 13087, 13088) that were either manufactured or had a pressure sensor replaced during servicing of the pump since January 1, 2009 could be affected.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm376723.htm

    Medtronic Guidewires

    Based on an internal investigation following a limited number of complaints, including one patient injury, Medtronic began notifying hospitals and distributors worldwide the week of October 21 that some models of its guidewires from recent lots have the potential for the coating on their surface to delaminate and detach. The notification requested that all potentially affected units be quarantined immediately and returned to the company as soon as possible for credit and replacement. Medtronic has also taken the necessary steps to prevent future shipments of the recalled products and notified regulatory agencies around the world as appropriate. The guidewires covered by this recall are designed to facilitate percutaneous coronary interventions or the placement of left ventricular leads for cardiac rhythm devices. They include specific lots from the following eight product lines that were manufactured after mid-April 2013: Cougar nitinol workhorse guidewire; Cougar steerable guidewire; Zinger stainless steel workhorse guidewire; Zinger steerable guidewire; Thunder extra-support guidewire; Thunder steerable guidewire; ProVia crossing guidewire; and the Attain Hybrid guide wire. Medtronic has announced that the FDA has classified the company's recently initiated voluntary field action related to certain guidewires as a Class I recall.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm375363.htm

    Nature's Pharmacy and Compounding Center Sterile Compounded Products

    Nature's Pharmacy and Compounding Center of Asheville, NC is voluntarily recalling all lots of sterile products compounded by the pharmacy that are not expired, to the consumer level. The product will be in the form of an injectable drug or an eye drop. The recall is being initiated due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. These products were supplied to the offices of licensed medical professionals and to patients by prescription within the pharmacy's local market area in North Carolina. They were distributed from January 1, 2013 to present (as of the November 13, 2013 press release). Out of abundance of caution and in the interest of the pharmacy's patients, Nature's Pharmacy has decided to voluntarily proceed with this recall process and to cease production of all sterile products.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm375412.htm

    Nitroglycerin in 5% Dextrose Injection

    Baxter International Inc. has announced that it has initiated a voluntary recall of one lot of Nitroglycerin in 5% Dextrose Injection due to particulate matter found in one vial. There have been no reported adverse events associated with this issue to date (as of the November 27, 2013 press release). Baxter’s Nitroglycerin in 5% Dextrose Injection is packaged in 250 mL glass containers, with 12 glass containers per carton. The affected product code is 1A0694, and the affected lot number is G105197. Product affected by this recall was distributed to healthcare centers and distributors in Colombia, Saudi Arabia, and the U.S. Baxter is notifying customers, who are being directed not to use product from the recalled lot. Customers should locate and remove all affected product from their facility. The affected lot was distributed to customers between January 17, 2013, and October 10, 2013. Unaffected lot numbers can continue to be used according to the instructions for use.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm376942.htm

    OxyElite Pro Dietary Supplements

    The FDA has announced that USPlabs LLC is recalling certain OxyElite Pro dietary supplement products that the company markets. The company took this action after receiving a letter from the FDA stating that the products have been linked to liver illnesses and that there is a reasonable probability that the products are adulterated. In a review of 46 medical records submitted to the FDA by the Hawaii Department of Health, the records indicated that 27 patients (58%) had taken a dietary supplement labeled as OxyElite Pro prior to becoming ill. Seventeen of the 27 patients (63%) reported that OxyElite Pro was the only dietary supplement they were taking. One death has occurred among these patients, another patient has required a liver transplant, and others await liver transplants. In a warning letter issued to USPlabs LLC on October 11, 2013, the FDA informed the company that OxyElite Pro and another dietary supplement called VERSA-1 were deemed to be adulterated. The products contained aegeline, a new dietary ingredient (i.e., an ingredient not marketed in the U.S. before October 15, 1994) that lacks a history of use or other evidence of safety. The letter stated that failure to immediately cease distribution of all dietary supplements containing aegeline may result in enforcement action. In addition to the products being recalled, the FDA continues to advise consumers not to use any dietary supplements labeled OxyElite Pro or VERSA-1.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm374398.htm

    PENTAX OF-B194 Gas/Water Valve

    On September 16, 2013, PENTAX Medical Company initiated a voluntary nationwide recall of 76 PENTAX Gas/Water Valves, model OF-B194. The valves were offered as a separate purchase for use with PENTAX GI Video Endoscopes (90i/90k series and i10/k10 series). The OF-B194 Valve has been found to have a manufacturing defect that may prevent users from turning off the CO2 gas flow during an endoscopic procedure with the potential for serious hazard to the patient, including: peritonitis, perforations, sepsis, death, and bowel perforations requiring surgical repair. Customers who have OF-B194 PENTAX Gas/Water Valves have been advised to immediately examine their inventory and quarantine and stop using the product subject to the recall. Recalled OF-B194 Gas/Water Valves were manufactured and distributed from August 2009 through July 2013. A total of 704 valves were distributed worldwide in the following regions: Europe/Middle East/Africa, 300 valves; Asia Pacific, 278 valves; 24 valves in Japan; 26 valves in Canada; and 76 valves in the U.S. All units distributed have been recalled. Products can be identified by the model number (OF-B194) stamped on the valve. Corrected valves have a circle before the model number (O OF-B194).
    For more information, visit: www.fda.gov/Safety/Recalls/ucm373151.htm

    Spacelabs Anesthesia Workstations and Service Kits

    The FDA has notified healthcare professionals of a Class I Recall due to a potential defect in the CAS I/II Absorber products employed in the BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and Service Kits Part Number 050-0659-00 and 050-0901-00. The Bag-to-Vent switch in CAS I/II Absorbers may fail due to loose fastening hardware in an absorber. In the worst case, this would result in a large leak from the absorber circuit while operating in bag mode and could impede the ability to provide ventilation in bag mode. Operation in vent mode along with all monitoring and alarm functions will continue to operate normally. The affected products may cause serious adverse health consequences, including death.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm376772.htm

    TorFlex Transseptal Guiding Sheath Kit

    The FDA has notified healthcare professionals of the Class 1 recall of TorFlex Transseptal Guiding Sheath Kit. The sheath could remove particulate of less than 5 mm from the dilator. The particulate could potentially migrate into a patient’s bloodstream. On September 23, 2013, Baylis Medical Company sent an "URGENT DEVICE RECALL" letter to their customers. This recall covers 1,035 kits manufactured between 12/22/2011 and 07/24/2013.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm373958.htm

    Viscoelastic Products

    CLR Medicals International Inc. initiated a nationwide recall of Viscocel and Viscocel Plus, in response to FDA inspectional findings of deficiencies in the Quality System regulations for Medical Device Manufacturers. No injuries have been reported to date (as of the November 25, 2013 press release) for the Viscocel and Viscocel Plus products; however, multiple cases of endophthalmitis were reported in 2011 for the firm’s Visco Supreme, a similar product manufactured at the firm under the same conditions. Recalled Viscoelastic products were manufactured from September 2011 through September 19, 2013 and distributed from October 2011 through November 2013.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm376762.htm

    FDA Alerts

    HeartStart Automated External Defibrillators

    Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation, the FDA stated in a new safety communication for users of these previously recalled devices. The safety communication includes recommendations to better inspect and monitor the readiness of these devices, as well as steps to follow if someone must use a recalled device in an emergency situation. These devices were manufactured and distributed between 2005 and 2012 under the names HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite. In September 2012, Philips Healthcare initiated the recall of HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDs due to the failure of an internal electrical component. The recall affected approximately 700,000 devices. In a Medical Device Safety Notice dated November 19, 2013, Philips provided consumers with updated information about the failure of an internal electrical component that could cause the AEDs to fail to deliver a shock. The FDA will continue to closely monitor all AED manufacturers’ quality system practices and manufacturing changes that have persistently contributed to recall and adverse events associated with AEDs. In March 2013, the FDA issued a proposed order that if finalized would require manufacturers of AEDs and accessories to submit premarket approval applications that focus specifically on the critical requirements necessary to assure AEDs are safe and effective.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm377433.htm

    Low Molecular Weight Heparins

    The FDA is recommending that healthcare 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.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm373918.htm


    The FDA is warning the public that the anti-seizure drug Onfi (clobazam) can cause rare but serious skin reactions that can result in permanent harm and death. The FDA has approved changes to the Onfi drug label and the patient Medication Guide to describe the risk of these serious skin reactions. These skin reactions, called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), can occur at any time during Onfi treatment. However, the likelihood of skin reactions is greater during the first 8 weeks of treatment or when Onfi is stopped and then restarted. All cases of SJS and TEN in the FDA case series have resulted in hospitalization, one case resulted in blindness, and one case resulted in death. The Onfi drug label has been revised to add information about the risk for serious skin reactions to the Warnings and Precautions section and to the Medication Guide.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm377340.htm

    OTC Topical Antiseptic Products

    The FDA is requesting label and packaging changes to enhance the safe use of certain OTC topical antiseptic products. This request is the result of the FDA’s 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 to reduce the number of bacteria on patients’ skin prior to surgery or injections. However, most often, contamination of topical antiseptics occurs when organisms are introduced into the product by users. Therefore, healthcare professionals and patients should follow all label directions to decrease the chances of infection. To further reduce the risk of infection with improper topical antiseptic use and the possibility of these products becoming contaminated with bacteria during use, the FDA is requesting that manufacturers package antiseptics indicated for preoperative or preinjection skin preparation in single-use containers. The FDA also recommends that healthcare professionals and patients do not dilute antiseptic products after opening them. Applicators and any unused solution should be discarded after the single application. In order to provide users with important information about contamination that may occur during the manufacturing process, the FDA is also asking manufacturers to voluntarily revise the product labels for topical antiseptics to indicate whether the drug is manufactured as a sterile or nonsterile product.
    For more information, visit: www.fda.gov/Drugs/DrugSafety/ucm374711.htm

    Rosiglitazone-Containing Drugs

    The FDA has determined that recent data for rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl, and generics, do not show an increased risk of heart attack compared with the standard type 2 diabetes medicines metformin and sulfonylurea. As a result, the FDA is requiring removal of the prescribing and dispensing restrictions for rosiglitazone medicines that were put in place in 2010. This decision is based on the FDA’s review of data from a large, long-term clinical trial and is supported by a comprehensive, outside, expert re-evaluation of the data conducted by the Duke Clinical Research Institute. The FDA continues to evaluate the safety and effectiveness of drugs after they go on the market. In the case of rosiglitazone medicines, previous data from a large, combined analysis of mostly short-term, randomized clinical trials of rosiglitazone had suggested an elevated risk of heart attack, so the FDA required a Risk Evaluation and Mitigation Strategy (REMS), called the Rosiglitazone REMS program. The Rosiglitazone REMS program restricted the use of rosiglitazone medicines to help ensure that their benefits outweighed the risks. Although some scientific uncertainty about the cardiovascular safety of rosiglitazone medicines still remains, in light of the new re-evaluation of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, the FDA’s concern is substantially reduced and the rosiglitazone REMS program requirements will be modified. The FDA is also requiring revisions to the rosiglitazone prescribing information and the patient Medication Guide to include this new information.
    For more information, visit: www.fda.gov/Drugs/DrugSafety/ucm376389.htm


    Pfizer Inc. has announced that the FDA has approved the supplemental New Drug Application for Xeljanz (tofacitinib citrate) to include additional Patient-Reported Outcomes data in the label. These additional data show improvement in patients receiving Xeljanz based on health-related outcome measures reported by patients, including vitality, role emotional, physical function, bodily pain, social function, mental health, role physical, and general health, which are the eight domains of the Medical Outcomes Study Short-Form (36-Item) Health Survey (SF-36). Xeljanz 5 mg twice-daily was approved by the FDA in November 2012 for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate (MTX). In the U.S., Xeljanz may be used as monotherapy or in combination with MTX or other nonbiologic disease-modifying antirheumatic drugs (DMARDs). Xeljanz should not be used in combination with biologic DMARDs or potent immunosuppressants, such as azathioprine and cyclosporine.
    For more information, visit: www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_fda_approval_of_supplemental_application_to_expand_xeljanz_tofacitinib_citrate_labeling_to_