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Local Anesthesia News

St. Renatus, LLC Announces FDA Approval of Kovanaze (tetracaine HCl and oxymetazoline HCl) Nasal Spray for Use in Dentistry

Posted 1 Aug 2016 by Drugs.com

FORT COLLINS, Colo., July 12, 2016 /PRNewswire/ – St. Renatus, LLC, a privately held company based in Fort Collins, Colorado, is pleased to announce it received U.S. Food and Drug Administration (FDA) approval on June 29, 2016 for its first product, a new dental anesthetic, Kovanaze (tetracaine HCl and oxymetazoline HCl) Nasal Spray. This is the first product that allows for dental anesthesia to be administered through a nasal spray without using a needle. "For more than 100 years, the dental industry has delivered dental anesthesia using a needle injection. Now, through the efforts of a dedicated team, we have developed a revolutionary needle-free method for delivering pulpal anesthesia," said Steve Merrick, St. Renatus' CEO. Kovanaze is intended for use in dentistry as a topical anesthetic, delivered in the nasal cavity to achieve pulpal (tooth nerve) anesthesia for the ... Read more

Related support groups: Local Anesthesia, Kovanaze, Oxymetazoline/tetracaine

Anesthesia Safe for Kids, Doctors' Group Says

Posted 16 Jul 2016 by Drugs.com

FRIDAY, July 15, 2016 – Anesthesia eases the pain of millions of children who must have surgery every year, but parents who are worried about the safety of these medications should talk to their anesthesiologist about their fears, experts advise. "Particularly in infants and toddlers, surgery is only recommended when necessary for the child's health, so parents should not avoid an important procedure out of fear," said Dr. Randall Flick. He is chair of the Committee on Pediatric Anesthesia at the American Society of Anesthesiologists (ASA). "Physician anesthesiologists have completed years of special training to ensure safe, high-quality care, which should set parents' minds at ease," said Flick, who is also associate professor of pediatrics and anesthesiology at the Mayo Clinic in Rochester, Minn. There are many important details about children's health that anesthesiologists should ... Read more

Related support groups: Anesthesia, Local Anesthesia, Light Sedation, Bronchospasm During Anesthesia, Light Anesthesia

Anesthesia Safe for Infants, Toddlers, Study Says

Posted 7 Jun 2016 by Drugs.com

TUESDAY, June 7, 2016 – General anesthesia doesn't seem to harm young children's mental development, new research concludes. "A number of animal studies have suggested that exposure to commonly used anesthetic agents in early development could lead to deficits in learning, memory, attention and other cognitive functions," said study author Dr. Lena Sun. She is a professor of pediatric anesthesiology and pediatrics at Columbia University Medical Center in New York City. "However, few clinical studies have adequately addressed whether this is also true in humans," Sun said in a Columbia news release. The new study findings are "good news for parents whose children need anesthesia for elective surgery or a diagnostic procedure," she added. Still, the study leaves some important questions unanswered, Sun said. "We need to take a closer look at the effect of anesthesia on cognitive function ... Read more

Related support groups: Lidocaine, Anesthesia, Propofol, Ketamine, Xylocaine, Local Anesthesia, Bupivacaine, Marcaine, Diprivan, Novocain, Septocaine, Nitrous Oxide, Procaine, Light Sedation, Sevoflurane, Mepivacaine, Tetracaine, Isoflurane, Prilocaine, Halothane

FDA Medwatch Alert: Sensorcaine-MPF (bupivacaine HCl) by Fresenius Kabi: Recall - Presence of Particulate Matter

Posted 27 Apr 2016 by Drugs.com

ISSUE: Fresenius Kabi USA announced today it is voluntarily recalling a single lot (Lot Number 6111504; Product Code 470237) of Sensorcaine®-MPF (bupivacaine HCl) Injection, USP, 0.75%, 7.5 mg/mL, 30 mL fill in a 30 mL vial. The recall is being performed to the user level due to visible particulate matter characterized as glass observed by the company during inspection of reserve samples. Administration of a solution containing glass particulate matter by the epidural or retrobulbar (behind the eyeball) route may result in inflammation and injury, or cause blockage of vasculature around the eye or emboli in the vasculature of eye nerves. If the particulate goes undetected and solution is administered - depending on the particle size and number - it could block administration of the drug to the patient, causing a delay in therapy. If the particulates are able to pass through the catheter ... Read more

Related support groups: Local Anesthesia, Bupivacaine, Sensorcaine-MPF

FDA Medwatch Alert: Bupivacaine HCl Injection by Hospira: Recall - Iron Oxide Particulate In Glass Vials

Posted 25 Apr 2015 by Drugs.com

ISSUE: Hospira issued a voluntary recall of one lot of Preservative-Free Bupivacaine HCl Injection, USP, 0.5% (5 mg/mL), 30 mL Single-dose (NDC: 0409-1162-02, Lot 38-515-DK, Expiry 1FEB2016) due to one confirmed customer complaint of orange and black, visible particles embedded and free floating within a single-dose glass teartop vial. The particles were identified as iron oxide. This recall is being carried out to the user level (both human and veterinary). Risk factors associated with particulate include the potential for particulate to be injected and/or therapy may be delayed. If smaller pieces of the particulate break off and become free floating within the solution, it may be injected into the patient. Injected particulate may result in local inflammation, low-level allergic or immune responses, granuloma formation or mechanical irritation of tissue, in particular in patients ... Read more

Related support groups: Local Anesthesia, Bupivacaine, Marcaine, Marcaine HCl, Sensorcaine, Marcaine Spinal, Sensorcaine-MPF, Sensorcaine-MPF Spinal

FDA Medwatch Alert: Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall - Particulate Matter

Posted 17 Oct 2014 by Drugs.com

ISSUE: Hospira announced it will initiate a voluntary recall of one lot of 1% Lidocaine HCI for Injection, USP, 10 mg per mL, 30 mL Single-dose, Preservative-Free to the user level due to a confirmed customer report of particulate in a single unit. Hospira has identified the particulate as a human hair, embedded in and attached to a pinched area of the stopper. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. In the unlikely event that the particulate breaks and pieces are able to pass through the intravenous catheter, injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response to the particulate or microembolic effects. BACKGROUND: This lot (NDC 0409-4279-02; Lot 40-316-DK, Expiry 1APRIL2016) was distributed nationwide from May 2014 through June 2014. Hospira has initiated an ... Read more

Related support groups: Lidocaine, Xylocaine, Local Anesthesia, Xylocaine HCl For Spinal, Lidoject 2, Truxacaine, DentiPatch, Dilocaine, Xylocaine HCl, Lidoject 1, Xylocaine-MPF, Nervocaine, UAD Caine, Anestacaine, Xylocaine Duo-Trach Kit, L-Caine

FDA Medwatch Alert: Marcaine (Bupivacaine HCI Injection, USP), 0.5 percent, 30 ML, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates

Posted 18 Jun 2014 by Drugs.com

[Posted 06/18/2014] ISSUE: Hospira announced a voluntary nationwide recall to the user level for one lot of 0.5% Marcaine (Bupivacaine HCl Injection, USP), 30 mL, Single-dose Vial – Preservative Free (NDC 0409-1560-29), Lot 33-545-DD. The recall is due to a confirmed customer report of particulate embedded in the glass vial as well as visible particulate in the solution. Hospira has attributed the embedded particulate to a supplier’s glass defect. Hospira is working with its supplier on implementing corrective and preventive actions. Administered solution with particulate - depending on the particle size and number - could block administration of the drug to the patient, causing a delay in therapy. Particulate exposed to strong magnetic fields (e.g. MRI), could potentially dislodge and cause tissue damage. BACKGROUND: Marcaine is packaged 10 units per carton/100 units per case in gla ... Read more

Related support groups: Local Anesthesia, Marcaine

FDA Medwatch Alert: Compounded topical anesthetic creams

Posted 6 Dec 2006 by Drugs.com

[Posted 12/06/2006] FDA notified healthcare professionals and consumers about the serious public health risks related to compounded topical anesthetic creams. FDA issued warning letters to five firms to stop compounding and distributing standardized versions of topical anesthetic creams, marketed for general distribution. Exposure to high concentrations of local anesthetics, like those in compounded topical anesthetic creams, can cause grave reactions including seizures, irregular heartbeats and death. Compounded topical anesthetic creams are often used to lessen pain in procedures such as laser hair removal, tattoos, and skin treatments. They may be dispensed by clinics and spas that provide these procedures, or by pharmacies and doctors’ offices.[December 05, 2006 - News Release - FDA] Read more

Related support groups: Local Anesthesia

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Lidoderm, bupivacaine, Marcaine, Xylocaine Jelly, Septocaine, Novocain, procaine, Bactine, Nupercainal, view more... mepivacaine, Lidocaine Viscous, dibucaine, Pontocaine, Marcaine HCl, RectiCare, Xylocaine Viscous, epinephrine / lidocaine, ethyl chloride, Marcaine Spinal, articaine / epinephrine, LidaMantle, Sensorcaine, Zingo, Lidocream, Carbocaine, Naropin, Polocaine, bupivacaine / epinephrine, Scandonest Plain, Dermocaine, Vivacaine, Isocaine, Uro-Jet, Sensorcaine-MPF Spinal, Topicaine, AneCream, Akten, Uro-Jet AC, Pliaglis, Articadent, LidoSite, Lidozol, Xylocaine Dental, Octocaine 100, Lidovex, Lignospan Forte, Apicaine-X, DermacinRx Lidotral´╗┐, Kovanaze, LidoRxKit, CidalEaze, Lignospan, Anestafoam, Zorcaine, Derma Numb, Accu-Stream 360, LidoRx, Glydo, Lidopin, Numb Nuts, RadiaGuard, Orabloc, Nesacaine, Dermaflex, Xylocaine 10% Oral, Lidomar, Medi-Quik Spray, Protech First Aid Stik, Ela-Max 5, Ela-Max, Anestacon, Sensorcaine-MPF, ropivacaine, lidocaine / tetracaine, chloroprocaine, oxymetazoline / tetracaine, Lidosense 5, Xylocaine Topical, LMX 5, LMX Plus, LMX 4 with Tegaderm, Viractin, Xylocaine-MPF-Epinephrine, Polocaine-MPF, Naropin SDV, Naropin Polyamp, Synera, Naropin Novaplus, Nesacaine-MPF, Mericaine, Senatec, Laryng-O-Jet Spray, LMX 4, LTA Preattached 360 Kit, LTA Pediatric Kit, Rectacaine, LTA II Kit, S-Caine Peel