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  • FDA Drug Updates

    FDA New Approvals

    Amplatzer PFO Occluder Device

    The FDA has approved the Amplatzer PFO Occluder device. The PFO Occluder reduces the risk of a stroke in patients who previously had a stroke believed to be caused by a blood clot that passed through a small hole in the heart, called a patent foramen ovale (PFO), and then traveled to the brain. Learn more about the Amplatzer PFO Occluder device


    The FDA granted accelerated approval to olaratumab (Lartruvo, Eli Lilly and Company) for the treatment of patients with soft tissue sarcoma not amenable to curative treatment with radiotherapy or surgery and with a histologic subtype for which an anthracycline-containing regimen is appropriate. Learn more about Lartruvo

    FDA Labeling Changes

    Testosterone Products

    The FDA approved class-wide labeling changes for all prescription testosterone products, adding a new Warning and updating the Abuse and Dependence section to include new safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other anabolic androgenic steroids (AAS). The new Warning will alert prescribers to the abuse potential of testosterone and the serious adverse outcomes, especially those related to heart and mental health that have been reported in association with testosterone/AAS abuse. In addition to the new Warning, all testosterone labeling has been revised to include information in the Abuse and Dependence section about adverse outcomes reported in association with abuse and dependence of testosterone/AAS, and information in the Warning and Precautions section advising prescribers of the importance of measuring serum testosterone concentration if abuse is suspected. Learn more about testosterone products

    FDA New Indications


    The FDA approved pembrolizumab (Keytruda, Merck & Co., Inc.) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test. This is the first FDA approval of a checkpoint inhibitor for first-line treatment of lung cancer. This approval also expands the indication in second-line treatment of lung cancer to include all patients with PD-L1-expressing NSCLC. Learn more about Keytruda


    The FDA approved nivolumab (Opdivo Injection, Bristol-Myers Squibb Company), for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy. Approval was based on data from an international, multi-center, open-label, randomized trial (CheckMate 141) comparing nivolumab with investigator’s choice of chemotherapy (either cetuximab, methotrexate, or docetaxel) in patients with recurrent or metastatic SCCHN with disease progression on or within 6 months of receiving platinum-based chemotherapy. Learn more about Opdivo


    The FDA modified the indication for erlotinib (Tarceva, Astellas Pharm.) for treatment of non-small cell lung cancer (NSCLC) to limit use to patients whose tumors have specific epidermal growth factor receptor (EGFR) mutations. The labeling change applies to patients with NSCLC receiving maintenance or second or greater line treatment. These indications will be limited to those patients whose tumors have EGFR exon 19 deletions or exon 21 L858R substitution mutations as detected by an FDA-approved test. The first-line indication previously was limited to patients with EGFR exon 19 deletions or exon 21 substitution mutations. Learn more about Tarceva


    The FDA has approved atezolizumab (Tecentriq, Genentech Oncology) for the treatment of patients with metastatic non-small cell lung cancer whose disease progressed during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving atezolizumab. Atezolizumab is a programmed death-ligand 1 blocking antibody that previously received FDA accelerated approval for the treatment of locally advanced or metastatic urothelial carcinoma that has progressed after platinum-containing chemotherapy. Learn more about Tecentriq

    FDA Recalls

    50 mm 0.2 Micron Filter from Baxter

    Baxter Corp. is recalling the 50 mm 0.2 Micron Filter after receiving reports about the presence of particulate matter and the potential absence of filter membrane layers in the filter set. The absence of a filter membrane layer and/or the presence of particulate matter in the set may contaminate a solution. This could result in bloodstream infections that may cause fever, septic shock, multiple organ dysfunction, and other serious adverse health consequences including death. Learn more about the 50 mm 0.2 Micron Filter from Baxter

    HeartWare Ventricular Assist Device (HVAD)

    HeartWare Inc. is recalling the HVAD controller due to a loose power connector which may cause the rear portion of the pump's driveline connector to become separated from the front portion of the driveline connector. The HVAD helps deliver blood from the heart to the rest of the body. It is used in patients who are at risk of death from end-stage left ventricular heart failure and who are waiting for a heart transplant. The HVAD is designed for use both in and out of hospital settings, including during patient transport. Learn more about the HVAD

    I.V. Flush Syringes by Nurse Assist

    Nurse Assist announced voluntary recall of all unexpired lots of I.V. Flush Syringes due to a potential link to Burkholderia cepacia bloodstream infections with the product. According to the CDC, the effects of B. cepacia on people “vary widely, ranging from no symptoms at all to serious respiratory infections, especially in patients with cystic fibrosis.” Nurse Assist voluntarily recalled its I.V. Flush Syringes after becoming aware of patients who developed B. cepacia bloodstream infections while receiving intravenous care using prepackaged saline flushes from Nurse Assist. Nurse Assist urges all healthcare facilities with affected product to discontinue use and return the product to the supplier. Learn more about I.V. Flush Syringes by Nurse Assist

    Leonhard Lang Defibrillation Electrode

    The Leonhard Lang defibrillation electrode is being recalled due to a connector compatibility issue with the Welch Allyn AED model 10. The user may not be able to connect the electrodes to the defibrillator when a shock is needed. This may result in a delay in delivering the electrical therapy needed to revive a patient in cardiac arrest. A delay in therapy could result in serious patient injury and/or death. Learn more about the Leonhard Lang defibrillation electrode

    Potential Separation and Detachment of Polytetrafluoroethylene (PTFE) Coating

    Medtronic announced that it has notified customers of a voluntary recall of certain lots of its Pipeline embolization device, Alligator retrieval device, and X-Celerator hydrophilic guidewire. The recall also includes the stylet containing UltraFlow flow directed micro catheters and Marathon flow directed micro catheters. This voluntary recall is being conducted due to the potential separation and detachment of the PTFE coating on parts of these devices. Should the PTFE separate from the delivery wire or stylets, PTFE particulate could enter the blood stream of the patient. PTFE in the blood stream, based on the size and quantity, could lead to a thromboembolic event. Learn more about potential separation and detachment of PTFE coating

    Premature Battery Depletion of St. Jude Medical ICD and CRT-D Devices

    The FDA is providing information and recommendations regarding St. Jude Medical’s advisory on ICD and CRT-D batteries that may fail earlier than expected. The FDA and St. Jude Medical are alerting patients, patient-caregivers, and physicians to respond immediately to Elective Replacement Indicator (ERI) alerts. Due to problems with these batteries, patients do not have the normal 3-month lead time for device replacement. Some batteries have run out within 24 hours of the patient receiving an ERI alert. St. Jude Medical has initiated a recall and correction of the affected devices. Learn more about premature battery depletion of St. Jude Medical ICD and CRT-D devices

    Side Head Regulator TT Tablets

    Ton Shen Health is recalling its Life Rising brand “Side Head Regulator TT” Tablets because they have tested positive for elevated levels of lead for children under the age of 18. Recent lab tests indicate certain lots of TT product have elevated levels of lead above the currently recognized acceptable levels for children. Lead poisoning can happen if a person is exposed to high levels of lead over short periods of time. Due to the test results affecting children and to the possibility of use by children, Ton Shen Health is recalling the TT product. Learn more about Side Head Regulator TT Tablets

    Skinny Bee Diet 500 mg

    Love My Tru Body is voluntarily recalling all of Skinny Bee Diet 500 mg MFD: 03.07.2106 EXP: 03.06.2018 distributed March 23–April 28, 2016 to the consumer level after FDA laboratory testing found Skinny Bee Diet to contain sibutramine, desmethylsibutramine, and phenolphthalein. The product is used as a weight loss dietary supplement and is packaged in white silver bottle with red capsules. Love My Tru Body notified its customers by U.S. Mail. Consumers who are currently in possession of recalled Skinny Bee Diet capsules should stop using the product and discard. Learn more about Skinny Bee Diet 500 mg

    Twin-Pass Dual Access Catheters by Vascular Solutions

    Vascular Solutions, Inc. initiated a nationwide recall (September 16, 2016) of Twin-Pass Dual Access catheters used in catheterization procedures. All unexpired lots of the product have been recalled because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. It is possible that the excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury or death. No injuries have been reported in association with this issue to date. Learn more about Twin-Pass Dual Access catheters by Vascular Solutions

    Willy Rusch Tracheostomy Tube Set

    Teleflex is recalling the Willy Rusch Tracheostomy Tube Set due to the possibility that the connector may disconnect from the tracheostomy tube during use on a ventilated patient. If the connector detaches from the tracheostomy tube shaft during use, it can deprive the patient of adequate ventilation and would require immediate medical intervention including changing the tracheostomy tube and placing a new tube. The use of affected products may cause serious adverse health consequences including oxygen deprivation, brain damage, and death. Learn more about the Willy Rusch Tracheostomy Tube Set

    FDA Alerts

    Direct-Acting Antivirals for Hepatitis C

    The FDA is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus. In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death. HBV reactivation usually occurred within 4-8 weeks. As a result, the FDA is requiring a Boxed Warning, its most prominent warning, about the risk of HBV reactivation to be added to the drug labels of these DAAs directing healthcare professionals to screen and monitor for HBV in all patients receiving DAA treatment. This warning will also be included in the patient information leaflet or Medication Guides for these medicines. Learn more about direct-acting antivirals for hepatitis C

    Multistate Outbreak of Burkholderia cepacia Infections (Update)

    An FDA investigation associated with a multistate outbreak has identified the bacteria Burkholderia cepacia in more than 10 lots of oral liquid docusate sodium manufactured by PharmaTech. The investigation also detected B. cepacia in the water system used to manufacture the product. These products were manufactured by PharmaTech and distributed and labeled by six firms—Rugby, Major, Bayshore, Metron, Centurion, and Virtus. The FDA also inspected other oral liquid docusate sodium manufacturers and collected samples of their products. The bacteria associated with this multistate outbreak has not been found in other oral liquid docusate sodium products the FDA tested. Learn more about the multistate outbreak of B. cepacia infections

    Stöckert 3T Heater-Cooler System (Update)

    The FDA is updating to provide new information about Mycobacterium chimaera infections associated with the use of the 3T in U.S. patients who have undergone cardiothoracic surgeries. This communication also contains updated recommendations to help prevent the spread of infection related to the use of these devices. Since issuing that communication, the FDA has continued to evaluate the causes and risk factors for transmission of microbial agents associated with heater-cooler devices and has collaborated with professional societies, public health partners, and experts to develop strategies to minimize patient exposure. Learn more about the Stöckert 3T Heater-Cooler System

    Radiation Therapy Devices by Multidata Systems International

    The FDA is concerned about the risks to patients from the use of devices manufactured and sold by Multidata Systems International Corporation ("Multidata"). The FDA knows of at least two Multidata medical devices that the company manufactured and distributed in the U.S. for which the FDA never received nor reviewed 510(k) premarket notifications. These devices include: (1) accessories to radiation therapy devices including the Real Time Dosimetry Waterphantom System and (2) the Dual Channel Electrometer. In addition, Multidata has not registered or listed their devices with the FDA, as required by federal law. The FDA is concerned that healthcare providers may be unaware of the risks associated with these devices. At this time, it is not known how many devices manufactured by Multidata are currently in use in hospitals and clinics throughout the U.S. Learn more about radiation therapy devices by Multidata Systems International

    Temporary Total Artificial Heart Companion 2 Driver System and Freedom Driver System by SynCardia Systems (Update)

    The FDA provided an update and additional information regarding SynCardia Systems, Inc.'s Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System), as well as to inform you of recent events with an additional SynCardia pneumatic driver system, the Freedom Driver System. The TAH-t functions as a bridge to a heart transplant in a small population of heart failure patients with severe bi-ventricular failure. There has continued to be a higher mortality rate for the subgroup of patients requiring pre-implant circulatory rescue interventions when using the C2 Driver System compared to those using the CSS Console. The mortality rates for patients who did not require pre-implant circulatory rescue interventions were similar for the C2 Driver System compared to the CSS Console. The most recent post-approval study results suggest that there is also a difference in clinical performance between the C2 Driver System and the CSS Console in terms of neurological adverse events. Learn more about the TAH-t C2 Driver System and Freedom Driver System by SynCardia Systems

    Xarelto and the Alere INRatio Device

    In July 2016, the Alere INRatio device was recalled due to the potential to generate inaccurate results. This device was used to monitor warfarin therapy in the control group of the ROCKET-AF clinical trial, which provided the primary data to support the 2011 approval of the blood thinner drug Xarelto (rivaroxaban). Xarelto is indicated to reduce the rates of stroke and blood clots in patients with non-valvular atrial fibrillation. Because of the concern about the Alere INRatio device, the FDA has completed a variety of analyses to assess the impact that this faulty monitoring device had on the ROCKET-AF study results. The Agency has determined that effects on strokes or bleeding, including bleeding in the head, were minimal. The FDA concludes that Xarelto is a safe and effective alternative to warfarin in patients with atrial fibrillation. Learn more about Xarelto and the Alere INRatio device