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  • FDA Drug Updates

    FDA New Approvals

    Botulism Antitoxin (Equine), Heptavalent (A, B, C, D, E, F, G)

    Cangene Corporation has announced that the FDA has approved Cangene's Botulism Antitoxin (Equine), Heptavalent (A, B, C, D, E, F, G) ("BAT") product for treatment of suspected or documented exposure to the botulinum neurotoxin A, B, C, D, E, F, or G. Cangene's BAT received orphan drug designation, and as a result of its approval, the product now has seven years of market exclusivity. BAT is the only botulism antitoxin available in the U.S. for treating naturally occurring, non-infant botulism, and for administering to patients under emergency conditions.
    For more information, visit: www.cangene.com/news.aspx


    The FDA has approved Diclegis (doxylamine succinate and pyridoxine hydrochloride) to treat pregnant women experiencing nausea and vomiting. Diclegis is a delayed-release tablet intended for women who have not adequately responded to conservative management of nausea and vomiting during pregnancy, such as dietary and lifestyle modifications. Diclegis is taken daily and must be taken whole, on an empty stomach. The recommended starting dose is two tablets taken at bedtime. If symptoms are not adequately controlled, the dose can be increased to a maximum recommended dose of four tablets daily (one in the morning, one mid-afternoon, and two at bedtime).
    For more information visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm347087.htm


    Guerbet has announced that the FDA has approved Dotarem (gadoterate meglumine), a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (≥2 years) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.
    For more information, visit: www.guerbet-us.com/fileadmin/user_upload/usa_home/news/Guerbet_Press_Release_03-21-13.pdf


    The FDA has approved Invokana (canagliflozin) tablets, used with diet and exercise, to improve glycemic control in adults with type 2 diabetes. Invokana works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering elevated blood glucose levels in diabetics. Invokana should not be used to treat people with type 1 diabetes; in those who have diabetic ketoacidosis; or in those with severe renal impairment, end-stage renal disease, or in patients on dialysis. Invokana is manufactured for Janssen Pharmaceuticals, Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm345848.htm

    Karbinal ER

    Tris Pharma has announced that the FDA has approved its New Drug Application for Karbinal ER (carbinoxamine maleate) Extended-release Oral Suspension 4 mg/5 mL a sustained-release histamine receptor blocking agent indicated for the treatment of seasonal and perennial allergic rhinitis in children ages 2 and up.
    For more information, visit: www.trispharma.com/news_karbinal_apr2013.php


    The FDA has approved Lymphoseek (technetium Tc 99m tilmanocept) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes. Lymphoseek is an imaging drug that helps locate lymph nodes; it is not a cancer imaging drug.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm343525.htm


    Bausch + Lomb announced that the FDA has approved the company's New Drug Application for Prolensa (bromfenac ophthalmic solution) 0.07% prescription eye drop, an innovative once-daily nonsteroidal anti-inflammatory drug for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Prolensa will be available in 1.6ml and 3ml bottle sizes.
    For more information, visit: www.bausch.com/en/Our-Company/Recent-News/2013-Archive/FDA-Approval-for-PROLENSA


    The FDA has approved Tecfidera (dimethyl fumarate) capsules to treat adults with relapsing forms of multiple sclerosis (MS). Tecfidera may decrease a person’s white blood cell count (lymphocytes). Lymphocytes help protect the body from infection and low counts can raise the risk of infection, although no significant increase in infections was seen in patients taking Tecfidera in clinical trials. Before starting treatment, and annually thereafter, the FDA recommends that the patient’s white blood cell count be assessed by their healthcare provider.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm345528.htm

    FDA New Formulations

    AcipHex Sprinkle Delayed-Release Capsules

    Eisai Inc. has announced that the FDA has approved AcipHex Sprinkle Delayed-Release Capsules 5 mg and 10 mg for the treatment of gastroesophageal reflux disease in children 1 to 11 years of age, for up to 12 weeks.

    TOBI Podhaler

    The FDA has approved TOBI Podhaler (tobramycin inhalation powder) for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes lung infections. TOBI Podhaler, a plastic, handheld inhaler device, contains a dry powder formulation of tobramycin, an antibiotic used to treat P. aeruginosa infection. The powder is inhaled twice daily, using the Podhaler device for 28 days. Patients should then stop TOBI Podhaler therapy for 28 days before resuming again.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm345123.htm

    FDA Recalls

    0.9% Sodium Chloride Injection

    Hospira, Inc. has announced that it is initiating a voluntary nationwide user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 1000 mL, Flexible Container, NDC 0409-7983-09. This action is due to one confirmed customer report where brass particulate was identified in the primary container in the form of several small grey/brown particles. To date, Hospira has not received reports of any adverse events associated with this issue for this lot, and has not identified any quality issues with retention samples for this lot. This recall is being conducted as a precautionary measure. The brass particulate was identified as containing copper, zinc, and lead. If the particulate is undetected, there is a potential for delay in therapy, or if administered, solution containing brass particulate may result in occlusion of small blood vessels. In a worst-case scenario, copper toxicity may potentially result in hemolysis and liver toxicity, including hepatic necrosis which may be fatal. The product is used as a source of water and electrolytes and is packaged in a 1000 mL flexible container, lot number 25-037-JT (the lot number may be followed by a -01 or -90), with an expiration date of January 1, 2015. The affected lot was distributed nationwide between January 2013 and March 2013 to wholesalers/distributors, hospitals and pharmacies. Hospira is investigating to determine the root cause.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm345963.htm

    Avastin Unit Dose Syringes

    Clinical Specialties is voluntarily recalling Avastin unit dose syringes. Clinical Specialties has received reports of five intra-ocular infections from a physician’s office and this is how the problem was identified. This product was being used solely as an off-label use by an ophthalmologist for macular degeneration and is packaged in sterile syringes. This product would be administered by a licensed physician in a surgery or physician’s office setting. The syringes were distributed to doctors’ offices in Georgia, Louisiana, South Carolina, and Indiana beginning December 18, 2012. Clinical Specialties has notified the physician’ offices by telephone and doctors that have product which is being recalled should stop using the Avastin immediately.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm344377.htm


    During a routine annual reserve inspection, visible particles were observed in Bivigam Immune Globulin Intravenous (Human), 10% Liquid lot number 120016. In the interest of patient safety, Biotest is voluntarily recalling this lot from the market. Inspections of other lots of product have not shown the presence of visible particles; therefore, no other lots of product are affected by this recall.
    For more information, visit: www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm346649.htm

    Guardian II and Guardian II NC Hemostasis Valves

    On February 28, 2013, Vascular Solutions Zerusa Ltd., a subsidiary of Vascular Solutions, Inc., initiated a nationwide recall of Guardian II and Guardian II NC hemostasis valves used in catheterization procedures. Specific lots of the products have been recalled because they pose a slightly increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death. Healthcare facilities that have the affected Guardian II and Guardian II NC hemostasis valves should remove the products from their inventory and return them to Vascular Solutions. The recalled products were manufactured from February 2012 to February 2013 and distributed from February 2012 to February 2013. The recalled products are specific lots of Model Numbers 8210, 8211, 8215, 8216, 8241, 8242, 8244, 8272, and 8274. A listing of the recalled lots is available from Vascular Solutions and has been provided to each facility that purchased the affected products. Vascular Solutions Zerusa Ltd. initiated the recall through an Urgent Medical Device Recall notification distributed to purchasers of the affected products. Vascular Solutions, Inc. in turn notified its customers of the specific lots subject to the recall and included instructions on how to return the affected products. No injuries have been reported in association with this issue. The FDA classified this as a Class I recall.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm344019.htm

    Omontys (peginesatide) Injection

    Affymax, Inc. and Takeda Pharmaceutical Company Limited along with the FDA are informing the public of a voluntary recall of all lots of Omontys (peginesatide) Injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal. To date, fatal reactions have been reported in approximately 0.02% of patients following the first dose of intravenous administration. The reported serious hypersensitivity reactions have occurred within 30 minutes after such administration of Omontys. There have been no reports of such reactions following subsequent dosing, or in patients who have completed their dialysis session. Since launch, more than 25,000 patients have received Omontys in the postmarketing setting. The rate of overall hypersensitivity reactions reported is approximately 0.2%, with approximately a third of these being serious in nature including anaphylaxis requiring prompt medical intervention, and in some cases hospitalization. All lots of Omontys are affected by this recall and distributed nationwide, including Puerto Rico and Guam, to dialysis centers via specialty distributors.
    For more information visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm340895.htm

    OneTouch Verio IQ Blood Glucose Meters

    LifeScan, Inc. is initiating a voluntary recall and replacement for all of its OneTouch Verio IQ blood glucose meters in the U.S., effective immediately. LifeScan is recalling and replacing all OneTouch Verio IQ Meters because at extremely high blood glucose levels of 1024 mg/dL and above, the meter will not provide a warning that the blood glucose is extremely high and will shut off, thereby potentially leading to incorrect treatment and delaying proper treatment.
    For more information, visit: www.jnj.com/connect/news/all/lifescan-announces-voluntary-recall-of-all-onetouch-verio-iq-blood-glucose-meters

    Pallimed Solutions Sterile Compounded Products

    Pallimed Solutions, Inc. of Woburn, MA, doing business as Pallimed Pharmacy, is voluntarily recalling all sterile compound products dispensed since January 1, 2013 to the user level. The recall resulted from a recent inspection conducted by the FDA and the Massachusetts Board of Registration in Pharmacy where visible particulates were observed in vials of sterile compounded products: Trimix, Bimix (Lot 02252013@3), Alprostadil, DMSO 50% – Irrigation (Lot 03122013@19), and Bacteriostatic Water For Injection (Lot 01072013@28). The potential public health risks are unknown as the particulate matter has not yet been identified. However, particulate matter has the potential to damage or obstruct blood vessels, which could induce emboli, cause systemic allergic reaction, or cause tissue responses to the foreign material. At this time a total of 5 affected vials were discovered. To date, no injuries or illnesses have been reported. In an abundance of caution, the pharmacy included all sterile compounded products dispensed since January 1, 2013, in the voluntary recall. The company took the precautionary recall measure to ensure patient safety. All products are packaged in glass vials. All products were distributed to patients and/or physicians’ offices through Friday, March 22, 2013, from Woburn, Massachusetts.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm345468.htm

    Symbios GOPump Elastomeric Infusion PumpKit

    Symbios Medical Products, LLC sent its customers an "URGENT MEDICAL DEVICE RECALL" notification letter detailing the reason for recall and products listed. The reason for the recall is that the flow restrictor bead may become displaced from its fitting, which may permit solutions to flow at a higher rate than intended. This product may cause serious adverse health consequences, including death. These kits were distributed between September 10, 2012 and February 11, 2013.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm344352.htm

    FDA Alerts

    Azithromycin (Zithromax or Zmax)

    The FDA is warning the public that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. Patients at particular risk for developing this condition include those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal heart rhythms, or arrhythmias. The FDA has issued a Drug Safety Communication as a result of their review of a study by medical researchers as well as another study by a manufacturer of the drug that assessed the potential for azithromycin to cause abnormal changes in the electrical activity of the heart. The FDA previously released a statement on May 17, 2012, about a study that compared the risks of cardiovascular death in patients treated with the antibacterial drugs azithromycin, amoxicillin, ciprofloxacin (Cipro), and levofloxacin (Levaquin), or no antibacterial drug. The study reported an increase in cardiovascular deaths and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug. The risks of cardiovascular death associated with levofloxacin treatment were similar to those associated with azithromycin treatment. Healthcare professionals should consider the risk of torsades de pointes and fatal heart rhythms with azithromycin when considering treatment options for patients who are already at risk for cardiovascular events. The FDA notes that the potential risk of QT prolongation with azithromycin should be placed in appropriate context when choosing an antibacterial drug.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm343350.htm

    Incretin Mimetic Drugs

    The FDA is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics. These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes. The FDA has asked the researchers to provide the methodology used to collect and study these specimens and to provide the tissue samples so the Agency can further investigate potential pancreatic toxicity associated with the incretin mimetics. Drugs in the incretin mimetic class include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto). These drugs work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal. They are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. The FDA has not reached any new conclusions about safety risks with incretin mimetic drugs. This early communication is intended only to inform the public and healthcare professionals that the Agency intends to obtain and evaluate this new information. The FDA will communicate its final conclusions and recommendations when its review is complete or when the Agency has additional information to report.
    For more information, visit: www.fda.gov/Drugs/DrugSafety/ucm343187.htm

    Medprep Consulting Inc.

    Med Prep Consulting, Inc. is voluntarily recalling all lots of all products compounded at its facility. The level of recall is to the user, that is, regional hospital pharmacies and related departments, and physicians’ office practices. The recall resulted from the pharmacy being notified by a Connecticut hospital, that it observed visible particulate contaminants in 50 mL bags of Magnesium Sulfate 2 g in Dextrose 5% in Water, 50 mL for Injection IV solution confirmed to be mold. These were unique and distinct lots compounded and dispensed by the pharmacy to the Connecticut hospital. At this time a total of five contaminated bags were discovered. In an abundance of caution, the pharmacy included all compounded products in the voluntary recall due to lack of sterility assurance. Administration of an intravenous product found to be contaminated with mold could result in a fatal infection in a broad array of patients. To date, no injuries or illnesses have been reported. The products are used for a wide range of therapeutic purposes for hospitalized inpatients and outpatients, and patients directly treated by a healthcare professional at a physician’s office practice facility or clinic. None of these products are dispensed directly to patients from retail pharmacies or to home care patients for either self-administration or nursing administration. All products are packaged in plastic infusion bags, plastic infusion devices, plastic syringes, and glass vials. Products packaged in plastic infusion bags, plastic infusion devices, plastic syringes, and glass vials were distributed directly to regional hospital pharmacies located in New Jersey, Pennsylvania, Connecticut, and Delaware. Products packaged in plastic syringes only, were distributed nationwide to physicians’ office practice facilities and clinics. All of these products were distributed to the described users through March 13, 2013, from Tinton Falls, New Jersey to both regional and nationwide locations.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm344229.htm