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  • FDA Drug Updates

    FDA New Approvals


    The FDA has approved Noctiva (desmopressin acetate) nasal spray for adults who awaken at least two times per night to urinate due to a condition known as nocturnal polyuria (overproduction of urine during the night). Noctiva is the first FDA-approved treatment for this condition. Noctiva is taken daily, approximately 30 minutes before going to bed. It works by increasing the absorption of water through the kidneys, which leads to less urine production. Learn more about Noctiva


    The FDA approved Odactra, the first allergen extract to be administered sublingually to treat house dust mite-induced nasal inflammation (allergic rhinitis), with or without conjunctivitis, in people 18 through 65 years of age. Odactra is manufactured for Merck, Sharp & Dohme Corp. (a subsidiary of Merck and Co., Inc.) by Catalent Pharma Solutions Limited, United Kingdom. Learn more about Odactra

    PhenoTest BC Kit

    The FDA has allowed marketing of the PhenoTest BC Kit, performed on the Pheno System. This is the first test to identify organisms that cause bloodstream infections and provide information about which antibiotics the organism is likely to respond to (antibiotic sensitivity). Unlike traditional identification and antibiotic susceptibility tests that may take 24 to 48 hours after detection in a positive blood culture to provide test results, the PhenoTest BC Kit can identify bacteria or yeast from a positive blood culture in approximately 1.5 hours. Risks associated with use of the PhenoTest BC Kit include false positive findings, which can occur when an individual not infected with organisms that cause bloodstream infections receives a test result that incorrectly indicates that he or she is infected. Results obtained from the test should always be interpreted alongside additional laboratory test results. For certain organisms, the test also provides important information to guide treatment recommendations in approximately 6.5 hours after the organisms are detected from blood cultures. Learn more about the PhenoTest BC Kit


    AstraZeneca announced that the FDA approved Qtern (dapagliflozin/saxagliptin) for the treatment of type 2 diabetes. The company noted that the once-daily therapy is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who have inadequate control with the SGLT-2 inhibitor Farxiga (dapagliflozin) or who are already treated with Farxiga and the DPP-4 inhibitor Onglyza (saxagliptin). Learn more about Qtern


    The FDA approved Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. Siliq is administered as an injection. Siliq is intended for patients who are candidates for systemic therapy or phototherapy and have failed to respond, or who have stopped responding to other systemic therapies. Learn more about Siliq


    The FDA approved Xermelo (telotristat ethyl) tablets in combination with somatostatin analog (SSA) therapy for the treatment of adults with carcinoid syndrome diarrhea that SSA therapy alone has inadequately controlled. Xermelo, in a regimen with SSA therapy, is approved in tablet form to be taken orally three times daily with food. Xermelo inhibits the production of serotonin by carcinoid tumors and reduces the frequency of carcinoid syndrome diarrhea. Learn more about Xermelo

    FDA New Indications


    The FDA approved lenalidomide (Revlimid, Celgene Corp.) as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant. In 2006, lenalidomide, an orally administered thalidomide analogue, received FDA approval for use with dexamethasone in patients with multiple myeloma who received at least one prior therapy. In 2015, the indication was expanded for use in combination with dexamethasone for the treatment of patients with multiple myeloma, to include newly diagnosed multiple myeloma patients who are not eligible for autologous stem cell transplant. Lenalidomide is also approved in myelodysplastic syndromes and mantle cell lymphoma. Learn more about Revlimid

    Vidas Brahms PCT Assay

    The FDA cleared the expanded use of the Vidas Brahms PCT Assay to help healthcare providers determine if antibiotic treatment should be started or stopped in patients with lower respiratory tract infections, such as community-acquired pneumonia, and stopped in patients with sepsis. This is the first test to use procalcitonin (PCT), a protein associated with the body’s response to a bacterial infection, as a biomarker to help make antibiotic management decisions in patients with these conditions. The test works by measuring PCT. High levels of PCT suggest a bacterial infection, while low levels suggest a viral infection or non-infectious causes. Clinicians may be able to use PCT and other information to withhold or stop antibiotics safely. Because PCT may indicate the presence of a variety of bacterial infections, it does not detect the exact cause of a patient’s symptoms. Learn more about the Vidas Brahms PCT Assay

    FDA Recalls

    Alaris Syringe Pump

    CareFusion is recalling the Alaris Syringe Pump because of a faulty Air-In-Line (AIL) sensor which may generate a false alarm and cause the syringe pump to stop supplying the infusion to the patient. If the AIL sensor is faulty, the false alarm may be repeated and require the healthcare provider to clear the alarm to restart the infusion. Interruption of infusion could lead to serious adverse health consequences or death. The Alaris Syringe Pump is an infusion pump that delivers fluids, such as nutrients, blood, and medications, into a patient’s body in controlled amounts. The syringe holds the solution, and the infusion tubing connects the syringe to the patient through intravenous or enteral access. The device is indicated for use in adults, pediatric patients, and infants and only used in hospitals and other healthcare facilities. Learn more about the CareFusion Alaris Syringe Pump

    Avella and Advanced Pharma Sterile Injectable Products

    Advanced Pharma, Inc. d/b/a Avella of Houston is conducting a voluntary recall of all unexpired sterile injectable products labeled “latex free” that were produced at Advanced Pharma, Inc.’s Houston location between September 1, 2016 and February 16, 2017 to the user level (hospitals and institutions) because such products may contain synthetic latex and/or natural latex. Avella and Advanced Pharma have been unable to confirm with clarity whether its “latex free” label statements are accurate in all cases and are therefore conducting this recall in an abundance of caution. The risk of potential adverse events related to a latex allergy, while rare, can range from local site reactions including swelling and inflammation to allergic reactions which could be life-threatening to users who are sensitive to latex. These products were not distributed directly to patients or consumers, but rather to healthcare facilities (hospitals and institutions). Learn more about Avella and Advanced Pharma sterile injectable products

    Comprehensive Reverse Shoulder

    Zimmer Biomet is recalling the Comprehensive Reverse Shoulder because these devices are fracturing at a higher rate than is stated in the labeling. Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death. The Comprehensive Reverse Shoulder is a shoulder replacement device that is surgically implanted to help restore arm movement. This device is beneficial for patients with rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy and previously failed shoulder joint replacement. Learn more about the Comprehensive Reverse Shoulder

    Edex 10 mcg

    Endo International announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling one lot of Edex (alprostadil for injection) 10 mcg to the consumer level. This product recall is due to the detection by Endo of a defect in the crimp caps used in the manufacture of the subject product lot. This defect has the potential to lead to a loss of container closure integrity, which could impact the product’s sterility assurance and may lead to serious adverse events such as infections, both localized at the site of injection and systemically. To date, Endo has not received adverse event reports related to this recall. Edex is a prescription-only intracavernous injection indicated for the treatment of male erectile dysfunction. The recall applies to the 10-mcg strength, packaged in a 2-pack carton, (NDC 52244-010-02), product lot number 207386, Expiration Date: May 2019. The affected lot was distributed from December 13, 2016 through February 13, 2017 to wholesale distributors and retail pharmacies throughout the United States. Learn more about Edex 10 mcg

    Human Chorionic Gonadotropin Freeze-Dried Vials

    Synergy Rx Pharmacy is voluntarily recalling all lots of Human Chorionic Gonadotropin (HCG) 5,000 units/vial and 11,000 units/vial to the retail level due to a lack of sterility assurance. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. Synergy Rx Pharmacy has not received any reports of adverse events, to date, related to this recall. HCG is an unapproved product being marketed as for weight loss. The product is packaged in 15 mL serum glass vials bearing a label that includes Synergy Rx Pharmacy’s name and expiration date. All lots of these products are affected. This recall impacts all sterile products distributed between 06/01/2016 and 12/22/2016. The product was only distributed to physician offices and clinics in Arizona, California, Wisconsin, and Minnesota. Learn more about HCG freeze-dried vials

    Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL)

    Exela Pharma Sciences, in association with marketer X-Gen Pharmaceuticals, Inc., is voluntarily recalling lot number PLND1613 of Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL), vials to the hospital or user level. Some of the vials have been found to contain particulate matter. Particulate matter has the potential to block blood vessels, provoke an immune reaction, and/or lead to microinfarcts which could be life threatening. Neither Exela nor X-Gen has received any reports of adverse events related to this recall. Ibuprofen Lysine Injection is indicated to close a clinically significant patent ductus arteriosus in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks’ gestational age when usual medical management is ineffective. The product is packaged in three 2 mL single-dose vials per carton. Learn more about Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL)

    LIFEPAK 1000

    Physio-Control is recalling the LIFEPAK 1000 due to an electrical issue which may cause the device to shut down unexpectedly during patient treatment. Physio-Control has determined that wear and oxidation formation between the battery and device electrical contacts may cause power interruptions. This may prevent the device from delivering the electrical shock needed to revive a patient in cardiac arrest. A delay in delivering this therapy could result in serious patient injury such as permanent organ damage, brain injury, or death. The LIFEPAK 1000 Defibrillator is used to deliver lifesaving electrical shocks to people with sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating. The LIFEPAK 1000 defibrillator is intended for use by medical professionals who are trained in CPR. Physio-Control anticipates contacting customers in May 2017 to schedule a hardware device correction for the LIFEPAK 1000 devices, which includes modifying the power control circuit board of the device and placing dielectric lubrication on the battery and device contacts. Learn more about LIFEPAK 1000

    FDA Alerts

    Balloon Angioplasty Devices to Treat Autonomic Dysfunction

    The FDA is alerting the public about an experimental procedure called Transvascular Autonomic Modulation (TVAM). This procedure may put patients at risk because it is being promoted as treatment for a variety of conditions even though it has not been formally studied in clinical trials. The procedure uses balloon angioplasty devices outside the scope of the FDA-approved indications for use. TVAM consists of threading a catheter into a patient’s venous system, such as the jugular vein, where a balloon attached to the catheter inflates to widen the vein walls. The FDA has not reviewed any data that supports the safety and effectiveness of balloon angioplasty devices for this intended use. For physicians providing care and potential clinical investigators: Be aware that the FDA has not cleared or approved any balloon angioplasty devices for the treatment of autonomic dysfunction, and has not been presented with data to support the use of such devices in treating autonomic dysfunction. Learn more about balloon angioplasty devices to treat autonomic dysfunction

    SPS-1 Static Preservation Solution

    The FDA wants to heighten awareness about the potential for bacterial contamination of SPS-1 Static Preservation Solution (SPS-1), and provide recommendations to healthcare facilities to help mitigate potential patient exposure to infectious bacteria. In addition, the FDA is calling attention to Organ Recovery Systems’ recall of specific SPS-1 lots and the company’s temporary suspension of production and distribution of all SPS-1 products. SPS-1 distributed by Organ Recovery Systems, Inc. is a clear to light yellow, sterile solution intended for the flushing and cold storage of kidney, liver, and pancreas at the time of organ removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient. Learn more about SPS-1