FDA New Approvals
The FDA has allowed marketing of a new device that when used along with other assistive devices, like a cane or guide dog, can help orient people who are blind by helping them process visual images with their tongues.
Learn more about BrainPort V100
Brio Neurostimulation System
The FDA has approved the Brio Neurostimulation System, an implantable deep brain stimulation device to help reduce the symptoms of Parkinson’s disease and essential tremor. The Brio Neurostimulation System can help some patients when medication alone may not provide adequate relief from symptoms such as walking difficulties, balance problems, and tremors.
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The FDA has approved Entresto (sacubitril/valsartan) tablets for the treatment of heart failure. The drug has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure. Entresto was reviewed under the FDA’s priority review program and was also granted fast track designation. Entresto is manufactured by Novartis.
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The Medicines Company announced the approval of Kengreal (cangrelor) by the FDA as an adjunctive therapy to percutaneous coronary intervention for reducing periprocedural thrombotic events in patients who have not been treated with a P2Y12 inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.
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Vertex Pharmaceuticals Incorporated announced that the FDA approved Orkambi (lumacaftor/ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis in people ages 12 and older with two copies of the F508del mutation. It is only indicated for these patients, who can be identified with a genetic test.
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Sapien 3 THV
The FDA has approved the Sapien 3 Transcatheter Heart Valve (THV) for patients with aortic valve stenosis. Aortic valve stenosis obstructs blood flow from the heart into the aorta, which can lead to serious heart problems. The Sapien 3 THV is approved for patients with aortic valve stenosis who are inoperable or at high risk for death or complications associated with open-heart surgery.
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FDA New Dose Strengths
Orexo has announced that it has received approval from the FDA of medium dosage strength of Zubsolv (buprenorphine/naloxone CIII sublingual tablet) for maintenance treatment of opioid dependence. The new dosage strength is 2.9mg/0.71mg buprenorphine/naloxone CIII sublingual tablets. The new 2.9mg/0.71mg dosage strength is expected to be launched during second half of 2015.
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FDA New Indications
Eisai Inc. announced that the FDA has approved Fycompa (perampanel) CIII for adjunctive therapy in the treatment of primary generalized tonic-clonic seizures, one of the most common and severe forms of generalized seizures with a high incidence of morbidity and mortality.
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Novartis announced that the FDA has approved Promacta (eltrombopag) for the treatment of children six years and older with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Promacta was approved by the FDA in 2008 for use in adult patients with the same condition.
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Impax Specialty Pharma announced that the FDA has approved Zomig Nasal Spray (zolmitriptan) for use in pediatric patients 12 years of age and older for the acute treatment of migraine with or without aura.
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Covidien Shiley Neonatal and Pediatric Tracheostomy Tubes
Medtronic announced that it began notifying hospitals and distributors worldwide that affected lots of its Covidien Shiley tracheostomy tubes were formed with a wider-angle bend than standard models manufactured after November 29, 2012. The company initiated the field action following customer complaints that included reports of 12 serious patient injuries, such as breathing difficulties that impacted oxygen levels, immediately upon tube placement or discomfort. Replacement of the tracheostomy tube with product manufactured prior to November 29, 2012 addressed the patient breathing difficulty or discomfort.
Learn more about Covidien Shiley Neonatal and Pediatric Tracheostomy Tubes
FLOW-i Anesthesia Systems
The FDA is providing notification of a Class I recall of FLOW-i Anesthesia Systems by Maquet. The firm has received several complaints where patient cassettes, which are the center of gas flow in the system, have come loose. The patient cassette locking device may accidentally release the patient cassette from its mount when users perform a change of system. This may cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately.
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Lifesaver Single Patient Use Manual Resuscitator
The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medical device used to provide temporary breathing support for patients during periods of acute ventilatory failure. The oxygen intake port may be blocked, which can prevent the bag from filling. This may prevent the device from delivering breathing support to the patient. A delay in treatment may potentially lead to patient injury or death. On May 14, 2015, Teleflex sent an urgent medical device recall letter to customers asking them to immediately discontinue use and quarantine the recalled product. Customers are asked to return any affected product together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical.
Learn more about the Lifesaver Single Patient Use Manual Resuscitator
M/L Taper with Kinectiv Technology Prosthesis
A process monitoring failure led to higher than expected amounts of manufacturing residues left on the Zimmer M/L Taper with Kinectiv Technology Femoral Stems and Necks. These residues can cause serious adverse health issues including allergic reactions, pain, infections, or death. Use of these products may require the need for a revision surgery to replace the affected implant. Manufacturing and distribution dates: March 31, 2015 through April 20, 2015.
Learn more about M/L Taper with Kinectiv Technology Prosthesis
G&C Natural Nutrition, Inc. is voluntarily recalling all lots of Pyrola, 430mg/capsule. Advanced Joint Formula capsules may contain undeclared diclofenac and chlorpheniramine. The product was sold to distributors and consumers nationwide through phone orders and online from April 2013 through June 2015.
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Codeine Cough-and-Cold Medicines in Children
The FDA is investigating the safety of using codeine-containing medicines to treat coughs and colds in children <18 years because of the potential for serious side effects, including slowed or difficult breathing. Children, especially those who already have breathing problems, may be more susceptible to these serious side effects. Parents and caregivers who notice any signs of slow or shallow breathing, difficult or noisy breathing, confusion, or unusual sleepiness in their child should stop giving their child codeine and seek medical attention immediately by taking their child to the emergency room or calling 911.
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The FDA is warning that permanent loss of skin color may occur with use of the Daytrana patch (methylphenidate transdermal system) for attention-deficit hyperactivity disorder. The FDA added a new warning to the drug label to describe this skin condition, which is known as chemical leukoderma.
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The FDA is warning consumers who purchase Diazepam, an anti-anxiety medication, on the internet of the potential risk that this drug may be counterfeit. The World Health Organization has reported 700 adverse events from patients in Central Africa taking mislabeled Diazepam that was actually the anti-psychotic drug Haloperidol. The patients who mistakenly took Haloperidol suffered acute contractions of the muscles of the face, neck, and tongue (dystonia). While it has not been confirmed that the counterfeit Diazepam in Africa was purchased online and the FDA has no confirmed reports that these counterfeit products have entered the US, the FDA advises consumers who purchased Diazepam online to check if the pills they received are authentic. The counterfeit tablets are light yellow in color, scored across the center of the tablet on one side, and bear the letters AGOG on the other side.
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HeartWare Ventricular Assist System
Heartware recently conducted multiple recalls for this device. The alignment guides in the power supply connector ports may wear down over time. This can cause the connection pins to become twisted or bent, and eventually prevent the patient from connecting the device controller to their HVAD. An interruption in this electrical connection would cause the pump to stop, which could cause serious patient injury or death. Also, the battery that powers an alarm in the controller may fail over time. If the battery fails, the alarm will not alert the patient in the event that both external power sources for the HVAD are disconnected. Finally, damage to the driveline connector may occur if the driveline is pulled too often with too much force. The driveline is a tube that connects the HVAD’s pump to the external controller and power source. Severe damage or disconnection of the driveline from the controller can cause electrical issues or pump stops that may lead to serious patient injury or death.
Learn more about the HeartWare Ventricular Assist System
Based on reviews of additional safety reports from patients treated with the anti-seizure drug Potiga (ezogabine), the FDA has determined that the potential risks of vision loss due to pigment changes in the retina and of skin discoloration can be adequately managed by following the current recommendations in the Potiga labeling. To further explore any potential long-term consequences of these pigment changes, the FDA has required GlaxoSmithKline to conduct a long-term observational study.
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Unapproved Prescription Otic Products
The FDA has announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear pain, infection, and inflammation. The unapproved prescription ear drops contain active ingredients such as benzocaine and hydrocortisone, and have not been evaluated by the FDA for safety, effectiveness, and quality. The labels on these products do not disclose that they lack FDA approval, and healthcare professionals may not be aware of their unapproved status.
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