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  • FDA Drug Updates

    FDA New Approvals

    Advate with Baxject III Reconstitution System

    Baxter International Inc. announced that the FDA has approved a new reconstitution system for Advate (Antihemophilic Factor [Recombinant]). Advate and the diluent come pre-packaged in the new Baxject III reconstitution system. The new reconstitution system was developed to reduce the number of steps in the reconstitution process for hemophilia A patients and caregivers, compared to the previous process with the Baxject II needleless transfer device. The new system will be commercially available with Advate in the coming months.
    For more information, visit: www.baxter.com/press_room/press_releases/2014/04_23_14_baxject3.html

    Cobas HPV Test

    The cobas HPV Test is the first FDA-approved HPV DNA test for women 25 and older that can be used alone to help a healthcare professional assess the need for a woman to undergo additional diagnostic testing for cervical cancer. The test also can provide information about the patient’s risk for developing cervical cancer in the future. Using a sample of cervical cells, the cobas HPV Test detects DNA from 14 high-risk HPV types. The test specifically identifies HPV 16 and HPV 18, while concurrently detecting 12 other types of high-risk HPVs. The FDA first approved the test in 2011 for use in conjunction with or as a follow-up to a Pap test. This approval expands the use of the test to include use as either a co-test or as a primary cervical cancer screening test. It does not change current medical practice guidelines for cervical cancer screening. The cobas HPV Test is manufactured by Roche Molecular Systems, Incorporated.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm394773.htm


    The FDA has approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma. Cyramza is an angiogenesis inhibitor that blocks the blood supply to tumors. It is intended for patients whose cancer cannot be surgically removed (unresectable) or has spread (metastatic) after being treated with a fluoropyrimidine- or platinum-containing therapy. The FDA reviewed Cyramza under its priority review program. Cyramza was also granted orphan product designation because it is intended to treat a rare disease or condition. Cyramza is marketed by Eli Lilly.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm394107.htm


    Merck has announced that the FDA has approved Grastek (Timothy Grass Pollen Allergen Extract) Tablet for Sublingual Use [2800 Bioequivalent Allergy Units (BAU)]. Grastek is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens. Grastek is approved for use in persons 5 through 65 years of age. Grastek is not indicated for the immediate relief of allergic symptoms. The prescribing information for Grastek includes a Boxed Warning regarding severe allergic reactions. Grastek will be available in US pharmacies in late April.
    For more information, visit: www.mercknewsroom.com/news-release/corporate-news/fda-approves-mercks-grastek-timothy-grass-pollen-allergen-extract-sublin

    Incruse Ellipta

    GlaxoSmithKline plc has announced that the FDA has approved Incruse Ellipta (umeclidinium) as an anticholinergic indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema. Following this approval by the FDA, it is anticipated that launch activities in the US will commence during the fourth quarter of 2014.
    For more information, visit: www.gsk.com/media/press-releases/2014/gsk-receives-approval-for-incruse-ellipta---umeclidinium--in-the.html


    The FDA has approved an oral suspension of mercaptopurine (Purixan, NOVA Laboratories Limited). Mercaptopurine is a 20mg/mL oral suspension. Purixan is indicated for the treatment of patients with acute lymphoblastic leukemia as part of a combination regimen.
    For more information, visit: www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm395156.htm


    Merck announced that FDA has approved Ragwitek (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use (12 Amb a 1-U). Ragwitek is an allergen extract indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen. Ragwitek is approved for use in adults 18 through 65 years of age. Ragwitek is not indicated for the immediate relief of allergic symptoms. The prescribing information for Ragwitek includes a Boxed Warning regarding severe allergic reactions. Ragwitek will be available in US pharmacies by the end of April.
    For more information, visit: www.mercknewsroom.com/news-release/prescription-medicine-news/fda-approves-mercks-ragwitek-short-ragweed-pollen-allergen-e


    The FDA has approved Sylvant (siltuximab) to treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma. Sylvant is an injection that works by blocking a protein that stimulates abnormal growth of immune cells. It is intended for patients with MCD who do not have HIV or human herpes virus 8. The FDA reviewed Sylvant under its priority review program. Sylvant was also granted orphan product designation because it is intended to treat a rare disease or condition. Sylvant is marketed by Janssen Biotech Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm394522.htm


    The FDA has approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. Tanzeum is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. Tanzeum has a Boxed Warning to warn that tumors of the thyroid gland (thyroid C-cell tumors) have been observed in rodent studies with some GLP-1 receptor agonists, but that it is unknown whether Tanzeum causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC), in humans. Tanzeum should not be used in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2. In clinical trials, the most common side effects observed in patients treated with Tanzeum were diarrhea, nausea, and injection-site reactions. The FDA approved Tanzeum with a REMS, which consists of a communication plan to inform healthcare providers about the serious risks associated with Tanzeum. Tanzeum is manufactured by GlaxoSmithKline, L.L.C.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm393289.htm


    The FDA has allowed marketing of an expandable, multi-sponge wound dressing to control the bleeding from certain types of wounds received in battle. For military use only, the XStat is a temporary dressing for wounds in areas that a tourniquet cannot be placed, such as the groin or armpit. The dressing can be used up to four hours, which could allow time for the patient to receive surgical care. The FDA reviewed XStat through its de novo classification process, a regulatory pathway for some novel, low- to moderate-risk medical devices that are first-of-a-kind. The XStat is manufactured by RevMedx, Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391755.htm


    The FDA has granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC). Zykadia is an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor that blocks proteins that promote the development of cancerous cells. It is intended for patients with metastatic ALK-positive NSCLC who were previously treated with crizotinib, the only other approved ALK tyrosine kinase inhibitor. The FDA granted Zykadia breakthrough therapy designation, priority review, and orphan product designation because the sponsor demonstrated through preliminary clinical evidence that the drug may offer a substantial improvement over available therapies; the drug had the potential, at the time the application was submitted, to be a significant improvement in safety or effectiveness in the treatment of a serious condition; and the drug is intended to treat a rare disease, respectively. Zykadia is marketed by Novartis.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm395299.htm

    FDA New Indications


    The FDA has approved ofatumumab (Arzerra Injection, for intravenous infusion; GlaxoSmithKline) in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia, for whom fludarabine-based therapy is considered inappropriate.
    For more information, visit: www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm393823.htm

    Medtronic Pacemakers and Defibrillators

    The FDA has approved an application from Medtronic for revised labeling for two cardiac resynchronization pacemakers (CRT-P) and eight cardiac resynchronization defibrillators (CRT-D), expanding the indication for use to patients with atrioventricular block and less severe heart failure. The FDA previously approved these devices for patients with more severe heart failure as evaluated by their physician using specific criteria. The new approved use includes patients with less severe heart failure, but who are already indicated to receive right ventricle pacing. With the new indication, these patients will be eligible to receive a device that will pace both sides of their heart instead of just the right. The expanded device approvals are for the following devices manufactured by Medtronic: Consulta CRT-P, Consulta CRT-D, Syncra CRT-P, Maximo II CRT-D, Concerto II CRT-D, Viva XT CRT-D, Viva S CRT-D, Protecta CRT-D, Protecta XT CRT-D, and Brava CRT-D.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm392861.htm

    FDA Recalls

    Abbott Acclaim Infusion Pumps & Hospira Acclaim Encore Infusion Pumps

    Hospira has received customer reports of broken door assemblies on the Abbott Acclaim infusion pumps and the Hospira Acclaim Encore infusion pumps. When the door is closed properly, it helps ensure that the tubing is seated properly to ensure appropriate flow of therapy to the patient. If the door assembly breaks, it may prevent the door from closing properly and an over-infusion or a delay of therapy may occur. If the door cannot be closed, the pump cannot be used, which can result in a delay of therapy. Affected Abbott Acclaim infusion pumps, list Number 12032, were manufactured from February 1998 to November 1998, and distributed from September 1998 through February 2004. Affected Hospira Acclaim Encore infusion pumps, list Number 12237, were manufactured from February 1997 to February 2010, and distributed from July 1999 through November 2013.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm395854.htm

    ARKON Anesthesia System with Version 2.0 Software

    Spacelabs Healthcare is recalling the ARKON Anesthesia System with Version 2.0 Software, due to a software defect. This software issue may cause the system to stop working and require manual ventilation of patients. In addition, if a cell phone or other USB device is plugged into one of the four USB ports for charging, this may also cause the System to stop working. This defect may cause serious adverse health consequences, including hypoxemia and death. Spacelabs Healthcare received one report related to the software defect. There have been no injuries or deaths associated with this malfunction. Affected products were manufactured and distributed from March 18, 2013 through June 17, 2013. Sixteen units were distributed to hospitals in North Carolina and South Carolina.
    For more information, visit: www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm393536.htm


    Cubist Pharmaceuticals, Inc. is voluntarily recalling one lot (Lot # 280453F) of Cubicin (daptomycin for injection) 500mg to the user level, due to the presence of particulate matter, identified as glass particles.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm394025.htm

    HeartWare Ventricular Assist System

    The HeartWare Ventricular Assist System is used as a bridge to cardiac transplantation in patients who are at risk of death from advanced heart failure. Also known as the HeartWare Ventricular Assist Device, the system is designed for in-hospital and out-of-hospital settings, including transportation by fix-wing aircraft or helicopter. HeartWare, Inc. received reports where the driveline connector locking mechanism failed to engage as a result of a faulty manufacturing assembly process. This failure could result in the pump stopping and potentially lead to serious adverse health consequences, including death. Affected products were manufactured from March 6, 2006 through October 17, 2013, and distributed from March 17, 2006 through November 29, 2013.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm395265.htm

    1% Lidocaine HCl Injection

    Hospira, Inc. will initiate a voluntary recall of one lot of 1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Single dose, Preservative-Free to the user level, due to a confirmed customer report of orange and black particulate within the solution and embedded within the glass vial. Hospira has identified the particulate as iron oxide. Risk factors associated with the particulate include the potential for particulate to be injected and/or a delay in therapy. This lot (Lot # 31-427-DK, Expiration Date 1JUL2015) was distributed nationwide to distributors/wholesalers, hospitals, and clinics from September 2013 through October 2013.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm394026.htm

    0.25% Marcaine

    Hospira, Inc. has announced that it will initiate a voluntary nationwide recall to the user level for one lot of 0.25% Marcaine (Bupivacaine HCl Injection, USP), 10 mL, Single-dose Vial, Preservative-Free (NDC 0409-1559-10), Lot 34-440-DD. The recall is due to a confirmed customer report of discolored solution with visible particles embedded in the glass as well as discolored solution. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. Hospira has attributed the embedded particulate to a supplier’s glass defect. As a result of this issue, Hospira is working with its supplier on implementing corrective and preventive actions. Marcaine is packaged 10 units per carton/100 units per case in glass fliptop vials. The impacted lot of Marcaine was distributed December 2013 through January 2014 to wholesalers/distributors, hospitals, and clinics nationwide.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm394340.htm

    Pipeline Embolization Device and Alligator Retrieval Device

    Covidien plc has announced that it has notified customers of a voluntary recall to address an issue with certain lots of its Pipeline Embolization Device and Alligator Retrieval Device where the polytetrafluoroethylene coating applied to the delivery wire could delaminate and detach from the devices. Covidien learned of this issue through internal product testing. The company has not received any reports of patient injuries to date related to this issue. A total of 32 Pipeline Embolization Devices and 621 Alligator Retrieval Devices are affected by this recall. The products were manufactured and distributed from May 2013 to March 2014. This issue involves both the Pipeline Embolization Device sold in the US, Australia, France, Germany, and United Kingdom, and the Alligator Retrieval Device, which is sold in the US, Australia, Canada, Europe, and Latin America. Covidien alerted customers to the recall by letter on April 1, 2014, and is arranging for replacement of the recalled products.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm392987.htm

    Propofol Injectable Emulsion

    Hospira has notified the public of a nationwide recall of seven lots of Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL) to the user level, due to a glass defect located on the interior neck of the vial. The defect was identified during a sample inspection where the glass vial contained visible embedded metal particulate. Free-floating metal particulates were also identified in vials upon further analysis. The affected lots were distributed nationwide to distributors/wholesalers, hospitals, and clinics from August 2013 through December 2013. On April 2, 2014, Hospira notified its customers via recall letter that the company had implemented corrective actions to the manufacturing process to prevent recurrence.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm393904.htm

    Sigma Spectrum Infusion Pumps with Master Drug Library

    Sigma Spectrum Infusion Pumps with Master Drug Library are intended to deliver controlled amounts of intravenous fluids including medicines, blood, blood products, and other mixtures required by patients. Baxter has received over 3500 reports of System Error 322 “Link Switch Error (low)” incidents in which the device has malfunctioned, including nine severe adverse events and no deaths. The System Error 322 occurs when the pump improperly detects that the door is open when it is physically closed. A System Error 322 may lead to an interruption or delay in therapy. If the System 322 occurs, the Sigma Spectrum infusion pump stops the infusion, an alarm sounds, and a light flashes (a visual “322” alarm). This requires a clinician to reset the alarm, reprogram the pump, and confirm the infusion is running properly. The use of affected product may cause serious adverse health consequences, including death. Affected products were manufactured from July 1, 2005 through January 15, 2014, and distributed from February 20, 2013 through January 15, 2014.
    For more information, visit: www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm395617.htm

    FDA Alerts


    The FDA is reminding healthcare professionals to stop prescribing and pharmacists to stop dispensing prescription combination drug products that contain more than 325mg of acetaminophen per tablet, capsule, or other dosage unit. If a pharmacist receives a prescription for a combination product with more than 325mg of acetaminophen per dosage unit, the FDA recommends that they contact the prescriber to discuss a product with a lower dose of acetaminophen. These products are no longer considered safe by FDA and have been voluntarily withdrawn. The FDA encourages pharmacists to return them to the wholesaler or manufacturer. These products were voluntarily withdrawn by the manufacturers at the FDA’s request to protect consumers from the risk of severe liver damage, which can result from taking too much acetaminophen. The FDA also asks wholesalers to remove the product codes for all prescription combination drug products containing more than 325mg of acetaminophen per dosage unit from their ordering systems and return all products to the manufacturers.
    For more information, visit: www.fda.gov/Drugs/DrugSafety/ucm394916.htm

    Epidural Corticosteroid Injection

    The FDA is warning that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. The injections are given to treat neck and back pain, and radiating pain in the arms and legs. The effectiveness and safety of epidural administration of corticosteroids have not been established, and the FDA has not approved corticosteroids for this use. The FDA is requiring the addition of a Warning to the drug labels of injectable corticosteroids to describe these risks.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm394530.htm

    GemStar Docking Station

    Hospira, Inc. has announced a nationwide medical device correction of the GemStar Docking Station (list number 13075), used in conjunction with the GemStar infusion pump. The correction is being taken following customer reports of two potential malfunctions that may occur with the GemStar Docking Station. The GemStar Docking Station is a separately sold accessory to the GemStar infusion pump and provides an alternate power source to the GemStar pump. When the docking station is used in conjunction with a GemStar Phase 3 pump (List 13000, 13100, or 13150) the potential exists for the GemStar Phase 3 pump to fail to power up while connected to the docking station. When a GemStar Phase 3 (List 13000, 13100, or 13150) or GemStar Phase 4 pump (List 13086, 13087, or 13088) is used in conjunction with both a docking station and an external battery pack accessory (List 13073), there is a possibility that the GemStar pump will display error code 11/003 and give an audible alarm, indicating excessive input voltage from the external sources. If the GemStar pump detects what is perceived to be more than 3.6 Volts as measured on the external voltage input, the pump will stop the infusion. This will trigger an audible alarm and the device will display alarm code 11/003.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm395828.htm

    GenStrip Blood Glucose Test Strips

    The FDA is advising people with diabetes and healthcare professionals to stop using GenStrip Blood Glucose Test Strips because the strips may report incorrect blood glucose levels. GenStrip Blood Glucose Test Strips, sold by Shasta Technologies LLC, are "third-party" blood glucose monitoring test strips. Shasta’s GenStrips are advertised for use with the LifeScan OneTouch family of glucose meters (e.g. Ultra, Ultra 2, and Ultra Mini). During a recent inspection of Shasta Technologies LLC, the FDA found extensive violations of federal regulations intended to assure the quality of products in the manufacturing of GenStrip Test Strips. The FDA found that Shasta Technologies did not have in place many of the requirements of a quality system. Without assurance of an adequate quality system, the FDA believes that the strips could report incorrect blood glucose levels.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm395270.htm

    Laparoscopic Power Morcellation in Hysterectomy and Myomectomy

    The FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids. It is estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma. If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm393809.htm