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  • FDA Drug Updates

    FDA New Approvals


    Genentech, a member of the Roche Group, has announced that the FDA has approved a subcutaneous (SC) formulation of Actemra (tocilizumab) for the treatment of adults with moderately to severely active rheumatoid arthritis who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide enough relief. Like the intravenous formulation, the SC formulation can be used both as a single-agent therapy and in combination with MTX or other non-biologic DMARDs. The Actemra pre-filled syringe injection formulation became available in November.
    For more information, visit: www.gene.com/media/press-releases/14557/2013-10-21/genentech-gains-fda-approval-for-new-sub


    The FDA has approved Adempas (riociguat) to treat adults with two forms of pulmonary hypertension. Adempas belongs to a class of drugs called soluble guanylate cyclase stimulators that help arteries relax to increase blood flow and decrease blood pressure. It is intended for patients with chronic thromboembolic pulmonary hypertension after surgery or patients who cannot undergo surgery, to improve their ability to exercise. Adempas is also indicated for patients with pulmonary arterial hypertension of unknown causes, inherited or associated with connective tissue diseases, to improve their ability to exercise and to delay clinical worsening of their condition. The FDA reviewed Adempas under its priority review program, which provides for an expedited six-month review of drugs that may offer major advances in treatment. Adempas carries a Boxed Warning alerting patients and healthcare professionals that the drug should not be used in pregnant women because it can harm the developing fetus. Female patients can receive the drug only through the Adempas REMS program. All female patients must be enrolled in the program, comply with pregnancy testing requirements, and be counseled regarding the need for contraception. The REMS restricted distribution program requires prescribers to be certified by enrolling in the program. Also, pharmacies must be certified and can dispense Adempas only to patients who are eligible to receive it under the REMS. Adempas is marketed by Bayer HealthCare Pharmaceuticals Inc.
    For more information, visit: www.fda.gov/newsevents/newsroom/pressannouncements/ucm370866.htm


    The FDA has approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia. Gazyva works by helping certain cells in the immune system attack cancer cells. Gazyva is being approved with a Boxed Warning regarding hepatitis B virus reactivation and a rare disorder that damages the material that covers and protects nerves in the white matter of the brain (progressive multifocal leukoencephalopathy). These are known risks with other monoclonal antibodies in this class and rare cases were identified in participants on other trials of Gazyva. Gazyva is marketed by Genentech, a member of the Roche Group.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm373209.htm

    Gonal-f RFF Redi-ject

    EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, has announced that the FDA approved Gonal-f RFF Redi-ject (follitropin alfa injection), a disposable prefilled drug injector pen intended for the subcutaneous injection of a liquid formulation of Gonal-f RFF. Gonal-f RFF Redi-ject will be available in December 2013 in three pen sizes: 300 IU, 450 IU, and 900 IU.
    For more information, visit: www.emdserono.com/cmg.emdserono_us/en/images/Gonal-f%20PR%2010.17_Final_tcm115_117193.pdf

    Juvederm Voluma XC

    Allergan, Inc. has announced that it has received approval from the FDA to market Juvederm Voluma XC, the first and only filler approved to temporarily correct age-related volume loss in the cheek area in adults over the age of 21. Juvederm Voluma XC will be available in fall 2013.
    For more information, visit: http://agn.client.shareholder.com/releasedetail.cfm?ReleaseID=799342


    Novo Nordisk has announced that the FDA has approved its Biologics License Application for recombinant coagulation factor VIII, Novoeight (turoctocog alfa). The FDA approved Novoeight for use in adults and children with hemophilia A for control and prevention of bleeding, perioperative management, and for routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Awaiting the expiration of existing patents, Novo Nordisk plans to launch Novoeight shortly after April 2015.
    For more information, visit: www.novonordisk.com/press/sea/novo-nordisk-news.asp?sShowNewsItemGUID=32394204-5C92-4964-A723-6B8FBC4D9059&sShowLanguageCode=en-GB

    NovoRapid FlexTouch and Levemir FlexTouch

    Novo Nordisk has announced that the FDA has approved the prefilled insulin pens NovoRapid FlexTouch and Levemir FlexTouch. Novo Nordisk plans to make FlexTouch available in the U.S. within the next year.
    For more information, visit: www.novonordisk.com/press/news/news.asp?sShowNewsItemGUID=bfb9fc66-a9ab-42ed-89e4-34d6e2b9b388&sShowLanguageCode=en-GB


    The FDA has approved Opsumit (macitentan), a new drug to treat adults with pulmonary arterial hypertension, a chronic, progressive, and debilitating disease that can lead to death or the need for lung transplantation. Similar to other members of its drug class, Opsumit carries a Boxed Warning alerting patients and healthcare professionals that the drug should not be used in pregnant women because it can harm the developing fetus. Female patients can receive the drug only through the Opsumit REMS program. This restricted-distribution program requires prescribers to be certified by enrolling in the program; all female patients to be enrolled in the program and comply with applicable pregnancy testing and contraception requirements before initiating treatment; and pharmacies to be certified and to dispense Opsumit only to patients who are authorized to receive it. Opsumit is marketed by Actelion Pharmaceuticals US, Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm371362.htm


    Antares Pharma, Inc. has announced the approval of Otrexup (methotrexate) injection by the FDA. Otrexup is the first FDA-approved subcutaneous methotrexate for once weekly self-administration with a single dose, disposable auto injector. Otrexup is indicated for adults with severe active rheumatoid arthritis who have had an insufficient therapeutic response to or are intolerant of an adequate trial of first line therapy including full dose non-steroidal anti-inflammatory agents, or children with active polyarticular juvenile idiopathic arthritis. The FDA also approved adult use of Otrexup for symptomatic control of severe recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy. The commercial launch of Otrexup is expected in early 2014.
    For more information, visit: www.antarespharma.com/files/8613/8175/5363/OTREXUP_FDA_Approval.pdf


    The FDA has approved Vizamyl (flutemetamol F 18 injection), a radioactive diagnostic drug for use with positron emission tomography (PET) imaging of the brain in adults being evaluated for Alzheimer's disease (AD) and dementia. Vizamyl works by attaching to beta amyloid and producing a PET image of the brain that is used to evaluate the presence of beta amyloid. A negative Vizamyl scan means that there is little or no beta amyloid accumulation in the brain and the cause of the dementia is probably not due to AD. A positive scan means that there is probably a moderate or greater amount of amyloid in the brain, but it does not establish a diagnosis of AD or other dementia. Vizamyl does not replace other diagnostic tests used in the evaluation of AD and dementia. Vizamyl is not indicated to predict the development of AD or to check how patients respond to treatment for AD. Vizamyl PET images should be interpreted only by healthcare professionals who successfully complete training in an image interpretation program. The Vizamyl drug labeling includes information about image interpretation. Vizamyl is manufactured for GE Healthcare by Medi-Physics, Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm372261.htm

    Zohydro ER

    The FDA has approved Zohydro ER (hydrocodone bitartrate extended-release capsules) for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate. Zohydro ER, a Schedule II controlled substance under the Controlled Substances Act, is the first FDA-approved single-entity (not combined with an analgesic such as acetaminophen) and extended-release hydrocodone product. Zohydro ER is in the class of extended-release/long-acting (ER/LA) opioid analgesics. Due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with ER/LA opioid formulations, Zohydro ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Zohydro ER is manufactured by Zogenix, Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm372287.htm


    Iroko Pharmaceuticals, LLC, has announced that the FDA has approved Zorvolex (diclofenac) capsules, a nonsteroidal anti-inflammatory drug, for the treatment of mild to moderate acute pain in adults. Zorvolex was approved at dosage strengths that are 20 percent lower than currently available diclofenac products. Zorvolex contains diclofenac as submicron particles that are approximately 20 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution.
    For more information, visit: www.iroko.com/press-releases/iroko-pharmaceuticals-receives-fda-approval-for-zorvolex-2

    FDA OTC Approval

    Nasacort Allergy 24HR

    The FDA has approved Nasacort Allergy 24HR (triamcinolone acetonide), a nasal spray for the nonprescription or over-the-counter (OTC) treatment of nasal allergy symptoms (nasal congestion, runny nose, sneezing, and itchy nose). Nasacort Allergy 24HR is labeled for use in children 2 years of age and older, adolescents, and adults. Nasacort Allergy 24HR belongs to a class of drugs known as glucocorticoids. It is the first drug in this class to be made available OTC for treatment of the symptoms of nasal allergies. Nasacort Allergy 24HR was initially approved as a prescription-only product (called Nasacort AQ) in the U.S. in 1996 for use in adults and adolescents 12 years of age or older. In 1997 it was approved for children 6 through 11 years of age and older, and in 2008 it was approved for children 2 through 5 years of age. Nasacort is marketed by Sanofi-aventis U.S. Inc.
    For more information, visit: www.fda.gov/Drugs/NewsEvents/ucm370973.htm

    FDA First Time Generic Approvals

    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


    Teva Pharmaceutical Industries Ltd. announced that the FDA has granted approval of the generic equivalent to Tobi (Tobramycin Inhalation Solution USP) in the U.S. Pursuant to an agreement with Novartis on this product, Teva expects to launch this product in late November.
    For more information, visit: www.tevapharm.com/Media/News/Pages/2013/1864100.aspx

    FDA New Indications


    UCB announced that the FDA has approved Cimzia (certolizumab pegol) for the treatment of adults with active ankylosing spondylitis.
    For more information, visit: www.ucb-usa.com/_up/ucb_usa_com/documents/October%202013%20AS%20FDA%20Approval.pdf


    Cubist Pharmaceuticals, Inc. has announced the approval of its supplemental new drug application (sNDA) by the FDA for Entereg (alvimopan). The sNDA approval expands the indication for the use of Entereg to accelerate the time to upper and lower GI recovery following surgeries that include partial bowel resection with primary anastomosis (i.e., re-connection of the bowel following removal of the resected segment). The FDA originally approved Entereg in 2008 to accelerate the time to upper and lower GI recovery following partial large or small bowel resection surgery with primary anastomosis.
    For more information, visit: www.cubist.com/news/110-cubist_announces_fda_approval_for_expanded_use_of_entereg_r

    Liposorber LA-15 System

    The FDA has approved Liposorber LA-15 System to treat pediatric patients with primary focal segmental glomerulosclerosis (FSGS) either before transplant, or after renal transplantation in which there is recurrence of FSGS. The Liposorber LA-15 System, a blood processing system that is used outside the body, includes disposable components and a control/monitor unit. The device works by removing certain lipoproteins from the patient’s blood. The Liposorber LA-15 System indication for pediatric patients is approved for pediatric use through the HDE marketing pathway.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm370931.htm


    The FDA has approved Sabril (vigabatrin) as add-on therapy for the treatment of refractory complex partial seizures (CPS) in children 10 years of age and older who have inadequately responded to several other treatments and if the possible benefit outweighs the risk of vision loss. This approval expands upon the age range of Sabril’s previous indication as adjunctive therapy for adults with refractory CPS. Sabril is not indicated as a first-line agent for refractory CPS. In addition to its refractory CPS indication, Sabril is approved for use in babies one month to two years of age with infantile spasms if the possible benefit outweighs the potential risk of vision loss.
    For more information, visit: www.lundbeck.com/upload/us/files/pdf/2013_Releases/Peds%20rCPS%20Indication.pdf

    FDA Labeling Change


    Eli Lilly and Company has announced the FDA has approved a product label addition for Cialis (tadalafil) to include data from a 26-week study that showed Cialis 5 mg for once daily use started in combination with finasteride significantly improved the signs and symptoms of benign prostatic hyperplasia (BPH) as early as 4 weeks, compared with placebo with finasteride, in men with BPH and an enlarged prostate. The combination of Cialis and finasteride initiated for BPH therapy is recommended for up to 26 weeks because the incremental benefit of Cialis decreases from 4 weeks until 26 weeks, and the incremental benefit of Cialis beyond 26 weeks is unknown. Cialis is approved by the FDA to treat erectile dysfunction (ED), the signs and symptoms of BPH, and both ED and the signs and symptoms of BPH (ED+BPH). Finasteride is a type II 5 alpha-reductase inhibitor approved by the FDA for the treatment of BPH in men with an enlarged prostate.
    For more information, visit: http://newsroom.lilly.com/releasedetail.cfm?ReleaseID=800395

    FDA Recalls

    Acetaminophen Infant Suspension Liquid, 160 mg/5 mL

    The Perrigo Company has announced that it has initiated a voluntary, nationwide product recall to the retail level of 18 batches of its acetaminophen infant suspension liquid, 160 mg/5 mL, sold in 2 oz. and 4 oz. bottles with syringes in a box under specific store brand products (follow link below for the complete list). The recall is being initiated because of the remote potential that a small number of packages might contain an oral dosing syringe without dose markings. The correct syringe should have a white or yellow plunger with specific dose markings for 1.25 mL, 2.5 mL, 3.75 mL, and 5 mL. If the product’s syringe has these dose markings, consumers can continue to use the product while following labeled use instructions. Using an oral syringe without dose markings can result in inaccurate dosing, especially in infants who could mistakenly get too high a dose. These recalled products are sold by distributors nationwide and distributed through retail stores. If the package contains an oral dosing device that does not have dose markings, the consumer should not use the product and should call Perrigo’s Consumer Affairs Department.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm373338.htm

    Albuterol Sulfate Inhalation Solution, 0.083%

    Nephron Pharmaceuticals Corporation (NPC) has initiated a voluntary recall, at the retail level, as a precautionary measure, due to results from their internal monitoring processes. NPC is asking retailers to remove the affected lots from store shelves and is asking consumers to discontinue use and dispose of any product they may have that is included in this recall. This voluntary recall will affect the following product: Albuterol Sulfate Inhalation Solution, 0.083%, in the 25-count packaging configuration (NDC# 0487-9501-25). Ten lots have been identified as impacted by this recall: A3A33A, A3A33B, A3A34A, A3A35A, A3A36A, A3A37A, A3A38A, A3A40A, A3A41A, and A3A42A. NPC performs aseptic process simulation as part of their internal processes to assure product quality. All of the lots listed met and passed NPC’s quality specifications at the time of manufacture. NPC has received no reportable adverse drug events for any of the lots included in this recall. Nevertheless, in accordance with published guidance regarding aseptic processing simulation from the FDA, NPC has decided to initiate this recall as a precautionary measure. No other NPC products or lots are impacted by this recall.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm371151.htm

    Avance, Aisys and Avance CS2 Anesthesia Delivery Systems

    GE Healthcare has initiated a voluntary field corrective for the Avance, Aisys and Avance CS2 anesthesia delivery systems with 8.00 (Avance and Aisys) or 10.00 (Avance CS2) software due to a potential safety issue. Clinicians may continue to use their Avance, Aisys and Avance CS2 anesthesia delivery system, but should be aware that a unique sequence of inputs and a collapsed bellow could result in delivery of higher-than-expected tidal volume when using the Pressure Control Ventilation – Volume Guarantee (PCV-VG) mode. All safety over-pressure controls and alarms will continue to function properly, however, over delivery of tidal volume may result in alterations to blood flow within the thorax that, under extreme circumstances, may result in gradual reductions in blood pressure. To date, no patient injuries have been reported with regards to this issue. To avoid this situation, when using PCV-VG mode, clinicians are advised not to adjust the ventilator tidal volume while in a manual ventilation mode. At any time during the use of the device, should an over delivery of tidal volume occur while in PCV-VG mode, transitioning to a different ventilation mode will resolve the issue. The affected units were manufactured from February 2011 through July 2013. GE Healthcare has begun notifying customers with affected units through an Urgent Medical Device Correction letter, which alerts users of the concern and provides instructions to mitigate the issue.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm371038.htm

    Bard LifeStent Solo Vascular Stent

    The FDA has notified health professionals and medical care organizations of a class 1 recall of the LifeStent Solo Vascular Stent due to deployment issues that range from failure to deploy, partial deployment, and difficult deployment. This product may cause serious adverse health consequences, including possible complications of bleeding, loss of limb, myocardial infarction, stroke, vascular surgery, and/or death. The affected products were manufactured and distributed from November 2011 to June 13, 2012. On September 30, 2013, Bard Peripheral Vascular sent an “Urgent: Medical Device Recall Notification” letter informing affected customers of the product, problem, and actions to be taken.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm371415.htm

    1g Cefepime for Injection

    B. Braun Medical Inc. (B.Braun) is voluntarily recalling one lot of 1g Cefepime for Injection USP and Dextrose Injection USP (Lot H3A744, catalog 3193-11) to the consumer level. The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit. Visible particulate matter, including metals, and organic material such as cotton fibers or hair, may illicit inflammatory responses, both chronic and acute, and may be life threatening (e.g., systemic inflammatory response syndrome (SIRS and/or anaphylaxis). If a right to left cardiac shunt is present, the particulate may lead to arterial emboli and result in stroke, myocardial infarction, respiratory failure, and loss of renal and hepatic function or tissue necrosis. Other adverse effects associated with intravenous injection of particulate matter include foreign body granulomata, particularly in the lungs, and local irritation of blood vessels. B.Braun has not received any reports of adverse events related to this lot to date. The affected lot H3A744, which expires January 2015, was distributed nationwide to licensed distributors, hospitals and pharmacies, and distributed to customers between the dates of February 4, 2013 and March 1, 2013.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm371031.htm

    Engström Ventilator, Aespire View, Aisys, and Avance Anesthesia Machines

    GE Healthcare has initiated a voluntary field corrective action due to a potential safety issue that involves unresponsive buttons on the display of the Engström ventilator and Aespire View, Aisys, and Avance anesthesia machines. Due to a manufacturing issue, the buttons on the left, right, and bottom keypads may not always detect a user’s button presses. This may result in the inability to access certain menu functions, which could possibly lead to delay in treatment. To date, no patient injuries have been reported with regards to this issue. The affected units were manufactured between the dates of April 23, 2013 and July 22, 2013. Clinicians may continue to use their Engström ventilator and Aespire View, Aisys, and Avance anesthesia machines, but should be aware of this potential safety issue. GE Healthcare has begun notifying customers with affected units through an Urgent Medical Device Correction letter, which alerts users of the concern and provides instructions to mitigate the issue.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm371097.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), 75 mg/30 mL, Single-dose Vial – Preservative Free (NDC 0409-1559-30), Lot 25-220-DD. The recall is due to a confirmed customer report of discolored solution with visible particles inside the glass vial as well as embedded in the glass. The embedded particulate was identified as iron oxide measuring approximately 3mm in diameter. 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 their 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 August 2013 through October 2013 to wholesalers/distributors, hospitals, and pharmacies.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm371412.htm

    MedStream Programmable Infusion Pump and Refill Kits

    The FDA and Codman & Shurtleff, Inc. has notified healthcare professionals of the class 1 recall of MedStream Programmable Pump and MedStream Refill Kit due to air in the pump reservoir, which may release a higher dosage of drug than expected, leading to drug overdose. This product may cause serious adverse health consequences, including hypotension, bradycardia, loss of consciousness, and/or death. On August 13, 2013, Codman & Shurtleff, Inc. sent a Medical Device Field Safety Notice Letter to U.S. and International customers. The affected products were manufactured from March 2009 to September 2012 and distributed from January 08, 2010 to July 19, 2013.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm371988.htm

    Specialty Medicine Compounding Pharmacy

    Specialty Medicine Compounding Pharmacy is voluntarily recalling all lots of certain unexpired human and veterinary sterile products to the consumer level due to particulate matter found in vials of a compounded dextrose injection product dispensed to a local hospital. Further testing and analysis of the medication is being conducted. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. The recalled products were distributed to hospitals and consumers located only within Michigan from July 1, 2013, through October 19, 2013. No products were distributed out of state. Customers that have a product that is being recalled should stop using it and contact the pharmacy to arrange for return of unused product.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm371563.htm

    FDA Alerts

    Bupropion HCl ER 300 mg Tablets

    The FDA is providing an update on its request for studies to assess the bioequivalence of marketed bupropion hydrochloride (HCl) extended-release (ER) 300 mg tablets. The FDA has completed their review of the studies from all four manufacturers of bupropion HCl ER 300 mg products currently on the market: Actavis, Inc., Mylan Inc., Par Pharmaceutical (formerly Anchen Pharmaceuticals), and Watson. Data submitted by Actavis, Inc., Mylan Inc., and Par Pharmaceutical confirmed that their generic bupropion HCl ER 300 mg tablet products are therapeutically equivalent to the reference-listed drug, Wellbutrin XL 300 mg. Patients can have confidence that these generics will have the same clinical effect and safety as the brand name drug. Based on data submitted by Watson, the FDA has determined that that company’s generic bupropion HCl ER 300 mg tablet product is not therapeutically equivalent to Wellbutrin XL 300 mg. Watson has agreed to voluntarily withdraw this product from the distribution chain. Also, the FDA has changed the Therapeutic Equivalence Code for the Watson product from AB (therapeutically equivalent) to BX (data are insufficient to determine therapeutic equivalence) in the Orange Book. The FDA does not anticipate a drug shortage.
    For more information, visit: www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm322161.htm

    Chlorofluorocarbon Inhalers

    The FDA will complete its phase-out of all inhaler medical products containing chlorofluorocarbons (CFCs) by December 31, 2013. This effort is to comply with an international treaty to protect the ozone layer by phasing out the worldwide production of numerous substances, including CFCs, which contribute to ozone depletion. While most inhaler products containing CFCs have already been phased out by the FDA, two products currently remain on the market: Combivent Inhalation Aerosol and Maxair Autohaler. However, these products will no longer be available after the end of this year.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm371901.htm


    The FDA has asked the manufacturer of the leukemia chemotherapy drug Iclusig (ponatinib) to suspend marketing and sales of Iclusig because of the risk of life-threatening blood clots and severe narrowing of blood vessels. The FDA will continue to evaluate the drug to further understand its risks and potential patient populations in which the benefits of the drug may outweigh the risks. Patients currently receiving Iclusig should discuss with their healthcare professionals the risks and benefits of continuing treatment with the drug. The drug manufacturer, Ariad Pharmaceuticals, has agreed to the FDA’s request to suspend marketing and sales of Iclusig while the FDA continues to evaluate the safety of the drug.
    For more information, visit: www.fda.gov/Drugs/DrugSafety/ucm373040.htm


    The FDA has approved changes to the drug label of the anti-seizure drug Potiga (ezogabine), underscoring risks of abnormalities to the retina in the eye, potential vision loss, and skin discoloration, all of which may become permanent. The revised label includes a new Boxed Warning, because of the risk of abnormalities to the retina. The FDA advises that Potiga use be limited to patients who have not responded adequately to several alternative therapies to decrease the frequency of seizures, or epilepsy, and for whom the benefits of treatment outweigh the risks. The FDA recommends that patients have eye exams by an ophthalmic professional before starting Potiga and every six months during treatment. Patients whose vision cannot be monitored should generally not take Potiga. If retinal pigmentary abnormalities or vision changes are detected, Potiga should be stopped unless no other suitable seizure treatment options are available and the benefits of treatment outweigh the potential risk of vision loss. In addition, healthcare professionals should stop Potiga treatment in patients who do not show substantial clinical benefit after adequate dose titration. Also included in the updated label are warnings regarding the risk for discoloration of the skin, nail, mucous membrane, and white-of-the-eye. The updated Potiga drug label states that if a patient develops skin discoloration, an alternate medication should be considered. These recommendations have been added to the Warnings and Precautions section of the drug label and to the patient Medication Guide, which should be included with every Potiga prescription filled. The FDA is working on modifying the current REMS for Potiga to address the risk of retinal pigmentary abnormalities, potential vision loss, and skin discoloration.
    For more information, visit: www.fda.gov/Drugs/DrugSafety/ucm372774.htm

    St. Jude Amplatzer Atrial Septal Occluder (ASO)

    The FDA is alerting healthcare providers and patients that in very rare instances, tissue surrounding the Amplatzer ASO can erode and result in life-threatening emergencies that require immediate surgery. According to published estimates, these events occur in approximately 1 to 3 of every 1,000 patients implanted with the Amplatzer ASO. As of March 31, 2013, there have been 234,103 Amplatzer ASO devices sold worldwide. The device rubbing against the wall of the heart can erode the tissue and create a hole. It can also lead to further scraping or erosion through tissue in the upper chambers (atria) of the heart, primarily in the top of the atria near the aorta. This scraping may also cause separate or simultaneous holes in the aortic root, potentially leading to blood building up in the sac surrounding the heart (cardiac tamponade). If too much blood builds up in this sac, the heart will not be able to work properly. Healthcare professionals should review the updated Instructions For Use for the Amplatzer ASO before implanting the device. Consider the potential for erosion when talking to patients about long- and short-term benefits and risks of treatment options, including implantation with the Amplatzer ASO. Educate patients implanted with the Amplatzer ASO to seek immediate medical attention if they develop symptoms such as chest pain, numbness, sudden weakness, dizziness, fainting, shortness of breath, or rapid heartbeat.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm371202.htm