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  • FDA Drug Updates

    FDA New Approvals


    The FDA approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is administered at the beginning of each meal, or within 20 minutes after starting a meal. Afrezza is not a substitute for long-acting insulin. Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes, and it is not recommended for the treatment of diabetic ketoacidosis, or in patients who smoke. Afrezza is manufactured by MannKind Corporation.
    For more information visit: www.fda.gov/newsevents/newsroom/pressannouncements/ucm403122.htm


    The FDA has approved Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma, a rare and fast-growing type of non-Hodgkin lymphoma. The action was taken under the agency’s accelerated approval program. Beleodaq also received orphan product designation by the FDA because it is intended to treat a rare disease or condition. Beleodaq is marketed by Spectrum Pharmaceuticals, Inc.
    For more information visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm403929.htm


    Strativa Pharmaceuticals, the branded division of Par Pharmaceutical Companies, Inc., announced that the FDA has approved Nascobal Nasal Spray in a single-use device. Nascobal is a prescription vitamin B12 supplement administered as one spray, one nostril, once a week. Nascobal Nasal Spray is indicated for the maintenance of normal hematologic status in pernicious anemia patients who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement. Nascobal Nasal Spray is also indicated as a supplement for other vitamin B12 deficiencies.
    For more information, visit: www.strativapharma.com/index.php?option=com_pr&view=release&Itemid=91&releaseid=1938770


    The FDA approved Sivextro (tedizolid phosphate), a new antibacterial drug, to treat adults with skin infections. Sivextro is approved to treat patients with acute bacterial skin and skin structure infections caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-resistant strains (MRSA) and methicillin-susceptible strains), various Streptococcus species, and Enterococcus faecalis. Sivextro is available for intravenous and oral use. Sivextro is marketed by Cubist Pharmaceuticals.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm402174.htm

    FDA New Indications


    The FDA approved a new use for Lymphoseek (technetium 99m tilmanocept) Injection, a radioactive diagnostic imaging agent used to help doctors determine the extent a type of cancer called squamous cell carcinoma has spread in the body’s head and neck region. This new indication will allow for the option of more limited lymph node surgery in patients with sentinel nodes negative for cancer. Lymphoseek is marketed by Navidea Biopharmaceuticals, Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm401085.htm

    FDA First-Time Generics

    Generic Version of Diovan

    Ohm Laboratories, Inc. (Ohm), a wholly owned subsidiary of Ranbaxy Laboratories Limited, announced that Ohm has received approval from the FDA to manufacture and market Valsartan 40mg, 80mg, 160mg, and 320mg tablets on an exclusive basis. Valsartan is indicated for the treatment of high blood pressure and heart failure. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ohm formulations to be bioequivalent and have the same therapeutic effect as that of the branded drug Diovan.
    For more information, visit: www.ranbaxy.com/ohm-laboratories-to-launch-valsartan-tablets/

    FDA Recalls

    Advocate Redi-Code+ Blood Glucose Test Strips

    Diabetic Supply of Suncoast, Inc. initiated a nationwide voluntary recall of all BMB-BA006A Advocate Redi-Code+ blood glucose test strip lots manufactured by BroadMaster Bio-Tech Corp, due to a labeling error which could result in confusion about which meter models the Redi-Code+ BMB-BA006A blood glucose test strips are designed to be used with. In the incorrect labeling, the test strips model (BMB-BA006A) was omitted. Suncoast is recalling the test strips in an effort to avoid confusion and the possible misuse of the Advocate Redi-Code+ blood glucose test strips with Taidoc meters.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm400668.htm


    Bristol-Myers Squibb Company issued a voluntary recall of six lots of Coumadin for Injection, 5mg single-use vials in the U.S. Visible particulate matter was found in a small number of Coumadin for Injection unreleased samples. Injected particulate metallic and non-metallic cellulose material can cause serious and potentially fatal adverse reactions such as embolization. Allergic reactions to the foreign material could also occur. To date, there have been no product complaints or adverse events reported to Bristol-Myers Squibb related to this issue. Coumadin for Injection 5mg single-use vials is packaged in cartons of six vials. The affected Coumadin for Injection includes the following six lots distributed to hospitals and pharmacies from November 2011 through January 2014: 201125, 201126, 201127, 201228, 201229, 201230. Coumadin for Injection was discontinued in early April 2014. The oral formulation, Coumadin tablets, is not impacted by this recall.
    For more information visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm403583.htm

    Flexi-Seal CONTROL Fecal Management System Kit

    A Class I Recall was issued for all Flexi-Seal CONTROL Fecal Management System Kits. No 510k application was submitted to the FDA. In addition, ConvaTec received reports from U.S. healthcare facilities of 13 adverse events including twelve serious injuries and one death for the period of February 2013 through March 2014. The Auto-Valve feature that is unique to the Flexi-Seal CONTROL Fecal Management System Kit has not consistently performed relative to the inflation and deflation of the device’s retention balloon. Use of this device may lead to: rectal damage (necrosis/perforation/ulceration or bleeding); expulsion of the device and/or leakage; fecal soiling of bed linen/incontinence pads, leading to skin deterioration around the anus, peeling skin, and raw, irritated lesions due to skin contact with fecal matter; and death.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm402172.htm

    Langston V2 Dual Lumen Catheters (Models 5540 and 5550)

    Vascular Solutions received reports that the inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during use. This may require a procedure to retrieve the separated piece from the patient’s vascular system. There are no reported patient injuries. The Langston V2 Dual Lumen Pressure Monitoring Catheter is used to deliver dye (contrast medium) into a patient’s blood vessels during medical imaging tests (angiographic studies) that allow clinicians to see internal body structures. The device also measures pressure within the blood vessel. Affected devices were manufactured from January 2014 to April 2014, and distributed from March 2014 to May 2014.
    For more information visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm404074.htm

    Marcaine (Bupivacaine HCI Injection, USP), 0.5%, 30mL, Single-Dose, Preservative-Free Vial

    Hospira announced a voluntary nationwide recall to the user level for one lot of 0.5% Marcaine (Bupivacaine HCl Injection, USP), 30mL, Single-dose Vial – Preservative Free (NDC 0409-1560-29), Lot 33-545-DD. The recall is due to a confirmed customer report of particulate embedded in the glass vial as well as visible particulate in the solution. Administered solution with particulate—depending on the particle size and number—could block administration of the drug to the patient, causing a delay in therapy. Particulate exposed to strong magnetic fields (eg, MRI) could potentially dislodge and cause tissue damage.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm401724.htm

    Medtronic Duet External Drainage and Monitoring System

    FDA notified healthcare professionals of a Class I recall of Medtronic Duet External Drainage and Monitoring System. The firm recalled the device because the patient line tubing may separate from the patient line connectors. According to the firm, the patient line is more likely to disconnect during frequent handling, such as connections where injections or sampling may frequently occur. The device failure may result in air within the skull (pneumocephalus), infection (such as meningitis, ventriculitis, encephalitis) and over/under drainage of the CSF that may contribute to serious adverse health consequences, including death. The firm has not received any reports of deaths.
    For more information visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm403876.htm

    FDA Alerts

    Captomer and Captomer-250

    FDA is warning consumers not to purchase or to use Thorne Research’s Captomer or Captomer-250, marketed as a dietary supplement for heavy metal toxicity and heavy metal chelation therapy. The products list DMSA (meso-2, 3-dimercaptosuccinic acid), as an active ingredient, which is contained in an FDA-approved prescription product indicated for the treatment of lead poisoning in children. FDA advises consumers to avoid all products offered over-the-counter (OTC) for chelation or detoxification. There are no FDA-approved OTC chelation products. Procedures involving chelation agents carry significant risks and should be performed only under medical supervision.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm401081.htm


    FDA is warning that the intravenous chemotherapy drug docetaxel contains ethanol, also known as alcohol, which may cause patients to experience intoxication or feel drunk during and after treatment. FDA is revising the labels of all docetaxel drug products to warn about this risk.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm402106.htm

    Lidocaine Viscous

    FDA notified health professionals, their provider organizations, and caregivers for infants, that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain. FDA is requiring a Boxed Warning to be added to the prescribing information (label) to highlight this information. Oral viscous lidocaine solution is not approved to treat teething pain, and use in infants and young children can cause serious harm, including death.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm402790.htm


    FDA has completed its safety review and has found no clear evidence of increased cardiovascular risks associated with use of the blood pressure medication olmesartan in diabetic patients. FDA believes the benefits of olmesartan in patients with high blood pressure continue to outweigh the potential risks.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm402616.htm

    Testosterone Products

    FDA notified health professionals and their medical care organizations that it is requiring the manufacturers of all approved testosterone products to include a warning in the drug labeling about the risk of blood clots in the veins, also known as venous thromboembolism, including deep vein thrombosis and pulmonary embolism.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm402054.htm

    Over-the-Counter Topical Acne Products

    FDA is warning that certain over-the-counter (OTC) topical acne products can cause rare but serious and potentially life-threatening allergic reactions or severe irritation. Consumers should stop using their topical acne product and seek emergency medical attention immediately if they experience hypersensitivity reactions such as throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue. Consumers should also stop using the product if they develop hives or itching. The hypersensitivity reactions may occur within minutes to a day or longer after product use. These serious hypersensitivity reactions differ from the local skin irritation that may occur at the product application site, such as redness, burning, dryness, itching, peeling, or slight swelling, that are already included in the Drug Facts labels. The hypersensitivity reactions may occur within minutes to a day or longer after product use. The OTC topical acne products of concern are marketed under various brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and as store brands. They are available as gels, lotions, face washes, solutions, cleansing pads, toners, face scrubs, and other products.
    For more information visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm402722.htm