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  • FDA Drug Updates

    FDA New Approvals

    Axumin

    Blue Earth Diagnostics Ltd. announced that the FDA has approved Axumin (fluciclovine F 18) injection, a molecular imaging agent indicated for use in positron emission tomography imaging to identify suspected sites of prostate cancer recurrence in men who have elevated blood levels of prostate specific antigen following prior treatment. Learn more about Axumin

    cobas EGFR Mutation Test v2

    Roche announced that the FDA has approved the cobas EGFR Mutation Test v2 for use with plasma samples, as a companion diagnostic for the non-small cell lung cancer therapy Tarceva (erlotinib). Learn more about the cobas EGFR Mutation Test v2

    Netspot

    Advanced Accelerator Applications announced that the FDA has approved Netspot (Somakit-TATE) for the localization of somatostatin receptor positive neuroendocrine tumors in adult and pediatric patients. Netspot received approval following a Priority Review from the FDA. Netspot is the new market name for Somakit-TATE (a kit for the preparation of gallium Ga 68 dotatate injection) in the U.S. Learn more about Netspot

    Ocaliva

    Intercept Pharmaceuticals, Inc. announced that the FDA has granted accelerated approval to Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis, previously known as primary biliary cirrhosis, in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. Ocaliva is an agonist of the farnesoid X receptor, a nuclear receptor expressed in the liver and intestine and a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways. Learn more about Ocaliva

    Probuphine

    Titan Pharmaceuticals, Inc. announced that the FDA has approved Probuphine (buprenorphine) implant for the long-term maintenance treatment of opioid dependence in clinically stable patients on 8mg or less a day of oral buprenorphine. The Probuphine subdermal implant, which utilizes Titan's proprietary ProNeura technology, delivers buprenorphine continuously for up to six months. The product is expected to be commercially available this summer and is recommended for use as part of a complete treatment program including counseling and psychosocial support. Learn more about Probuphine

    Tecentriq

    Genentech announced that the FDA granted accelerated approval to Tecentriq (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). Learn more about Tecentriq

    Zinbryta

    The FDA approved Zinbryta (daclizumab), a once-monthly, self-administered, subcutaneous treatment for relapsing forms of multiple sclerosis, Biogen and AbbVie announced. Because of its safety profile, the use of Zinbryta should generally be reserved for patients who have had an inadequate response to two or more therapies indicated for the treatment of multiple sclerosis. Learn more about Zinbryta

    FDA New Indications

    Lenvima

    Eisai Inc. announced that the FDA approved Lenvima (lenvatinib), the company's multiple receptor tyrosine kinase inhibitor, in combination with everolimus for the treatment of patients with advanced renal cell carcinoma who were previously treated with an anti-angiogenic therapy. Lenvima was first approved in the U.S. on February 13, 2015, for patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. Learn more about Lenvima

    Opdivo

    Bristol-Myers Squibb Company announced the FDA has approved Opdivo (nivolumab) for the treatment of patients with classical Hodgkin lymphoma who have relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin. Opdivo is also approved for the treatment of patients with unresectable or metastatic melanoma, for the treatment of patients with metastatic non-small cell lung cancer with progression on or after platinum-based chemotherapy, and for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. Learn more about Opdivo

    FDA Recalls

    Capnostream 20 and Capnostream 20p Patient Monitor Battery Packs

    Medtronic Respiratory & Monitoring Solutions is recalling the battery packs used on Capnostream 20 and Capnostream 20p Patient Monitors due to a manufacturing defect that causes an increase in temperature within the battery that may cause a fire in the system monitor. The use of affected products may cause serious adverse health consequences, including death. The Capnostream 20 and Capnostream 20p are used to monitor vital signs and levels of oxygen and carbon dioxide in neonatal, pediatric, and adult patients. Learn more about Capnostream 20 and Capnostream 20p Patient Monitor Battery Packs

    Hummi Micro-Draw Blood Transfer Device

    Hummingbird Med Devices Inc. is recalling the Hummi Micro-Draw Blood Transfer Device because the Y-shaped connector and the yellow tube may disconnect from each other prior to or during use. This could lead to blood or fluid leakage. Blood or fluid loss may result in serious adverse health consequences, including death. Learn more about the Hummi Micro-Draw Blood Transfer Device

    Nature Made Products

    Pharmavite LLC is recalling specific lots of Nature Made products due to possible Salmonella or Staphylococcus aureus contamination. The recalled products were distributed nationwide to various major retailers. Learn more about Nature Made Products

    SOS Telecom Products

    SOS Telecom, Inc. is voluntarily recalling all lots of select products to the consumer level because these products were tested by the FDA and found to contain Sildenafil, and analogs of Sildenafil. Sildenafil is a PDE-5 inhibitor that is the active ingredient in an FDA-approved drug for erectile dysfunction, making these products tainted dietary supplements and unapproved drugs. Sildenafil is not listed on the product labels. Learn more about SOS Telecom Products

    Well Care Compounding Pharmacy Sterile Compounded Products

    Well Care Compounding Pharmacy is performing a voluntary statewide recall in Nevada on all unexpired sterile compounded products due to FDA concern over lack of sterility assurance. The recall impacts all sterile compounded products distributed between 01/01/2016-04/29/2016. Well Care Compounding Pharmacy is conducting this recall after an FDA inspection. Learn more about Well Care Compounding Pharmacy Sterile Compounded Products

    FDA Alerts

    BiCNU

    The FDA is informing healthcare professionals that a counterfeit version of the FDA-approved cancer drug BiCNU (carmustine for injection) 100mg has been detected in some foreign countries. There is no indication at this time that counterfeit BiCNU has entered the legitimate U.S. drug supply chain and no indication that any U.S. patients have received counterfeit BiCNU. Learn more about BiCNU

    Canagliflozin

    The FDA is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (Invokana, Invokamet). The FDA has not determined whether canagliflozin increases the risk of leg and foot amputations. The FDA is currently investigating this new safety issue and will update the public when we have more information. Learn more about Canagliflozin

    Fluoroquinolone Antibacterial Drugs

    The FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options. An FDA safety review has shown that fluoroquinolones when used systemically (i.e., tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system. As a result, The FDA is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information. The FDA is continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available. Learn more about Fluoroquinolone Antibacterial Drugs

    Loperamide

    The FDA is warning that taking higher than recommended doses of the common over-the-counter and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death. The risk of these serious heart problems, including abnormal heart rhythms, may also be increased when high doses of loperamide are taken with several kinds of medicines that interact with loperamide. The FDA continues to evaluate this safety issue and will determine if additional FDA actions are needed. Learn more about Loperamide

    Nizoral (ketoconazole) Oral Tablets

    The FDA is warning healthcare professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and nail fungal infections. Use of this medication carries the risk of serious liver damage, adrenal gland problems, and harmful interactions with other medicines that outweigh its benefit in treating these conditions, which are not approved uses of the drug. Learn more about Nizoral (ketoconazole) Oral Tablets

    Olanzapine

    The FDA is warning that the antipsychotic medicine olanzapine can cause a rare but serious skin reaction that can progress to affect other parts of the body. The FDA is adding a new warning to the drug labels for all olanzapine-containing products that describes this severe condition known as drug reaction with eosinophilia and systemic symptoms. Learn more about Olanzapine

    Over-the-Counter Antacid Products Containing Aspirin

    The FDA is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. Many other products for these conditions are available that do not contain aspirin. Learn more about Over-the-Counter Antacid Products Containing Aspirin

    Stöckert 3T Heater-Cooler System

    The FDA has received reports of U.S. patients infected with Mycobacterium chimaera after undergoing cardiothoracic surgery that involved the use of the 3T. Currently, efforts are underway in the U.S. to determine if the infections in U.S. patients and M. chimaera isolates from samples taken from the 3T are linked with M. chimaera isolates from European patients who were infected and the M. chimaera previously identified at the 3T manufacturer’s production and servicing facility in Germany. Learn more about the Stöckert 3T Heater-Cooler System

    Zecuity

    The FDA is investigating the risk of serious burns and potential permanent scarring with the use of Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine headaches. Since marketing of the Zecuity patch began in September 2015, a large number of patients have reported they experienced burns or scars on the skin where the patch was worn. The reports included descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin. As a result, the FDA is investigating these serious adverse events to determine whether future regulatory action is needed, and will update the public with new information when the FDA review is complete. Learn more about Zecuity