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Anesthesia Blog

FDA Approves Ryanodex for the Treatment of Malignant Hyperthermia

Posted 1 day 6 hours ago by Drugs.com

WOODCLIFF LAKE, N.J.(BUSINESS WIRE) July 23, 2014 – Eagle Pharmaceuticals, Inc. (“Eagle” or “the Company”) (Nasdaq:EGRX) today announced that the U. S. Food and Drug Administration (FDA) has approved Ryanodex (dantrolene sodium) for injectable suspension indicated for the treatment of malignant hyperthermia (MH), along with the appropriate supportive measures. MH is an inherited and potentially fatal disorder triggered by certain anesthesia agents in genetically susceptible individuals. FDA had designated Ryanodex as an Orphan Drug in August 2013. Eagle has been informed by the FDA that it will learn over the next four to six weeks if it has been granted the seven year Orphan Drug market exclusivity. “We are very pleased with today’s approval of Ryanodex, which enables health care providers to better meet the needs of patients experiencing a life-threatening MH crisis,” said Scott Tarr ... Read more

Related support groups: Anesthesia, Dantrolene, Malignant Hyperthermia

FDA Medwatch Alert: Marcaine (Bupivacaine HCI Injection, USP) 0.25 percent, 10 ml, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates

Posted 23 Apr 2014 by Drugs.com

[Posted 04/22/2014] ISSUE: Hospira, Inc. announced a voluntary nationwide recall to the user level for one lot of 0.25% Marcaine (Bupivacaine HCl Injection, USP), 10 mL, Single-dose Vial – Preservative Free (NDC 0409-1559-10), Lot 34-440-DD. The recall is due to a confirmed customer report of discolored solution with visible particles embedded in the glass as well as discolored solution. Hospira has attributed the embedded particulate to a supplier’s glass defect. If the particulate goes undetected and solution is administered, it could block administration of the drug to the patient, causing a delay in therapy. Other risks include local inflammation, mechanical disruption of tissue or immune response to the particulate. BACKGROUND: Marcaine is packaged 10 units per carton/100 units per case in glass fliptop vials. The impacted lot of Marcaine was distributed December 2013 through Jan ... Read more

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

FDA Medwatch Alert: Propofol Injectable Emulsion, USP by Hospira: Recall - Visible Particulates

Posted 18 Apr 2014 by Drugs.com

ISSUE: Hospira notified the public of a nationwide recall of seven lots of Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL) to the user level due to a glass defect located on the interior neck of the vial. The defect was identified during a sample inspection where the glass vial contained visible embedded metal particulate. Free-floating metal particulates were also identified in vials upon further analysis. Injected particulate matter may result in local inflammation, phlebitis, and/or low level allergic response through mechanical disruption of tissue or immune response to the particulate. Capillaries, which may be as small as the size of a red blood cell, may become occluded. Chronically, following sequestration, particulate matter may lead to granulomatous formation, most likely in the lungs. Long term clinically meaningful impact is low if a patient has normal lung ... Read more

Related support groups: Anesthesia, Propofol, Diprivan, Propoven

FDA Medwatch Alert: Etomidate Injection/Pfizer-Mylan: Recall - Presence of Particulate Matter and/or Illegible and Missing Lot Number and/or Expiry Date

Posted 20 Feb 2014 by Drugs.com

ISSUE: Agila Specialties notified medical care organizations of a nationwide recall to the hospital/user level of 10 lots of Etomidate Injection 2 mg/mL – 10 mL and 20 mL (See the firm Press Release for a list of affected lot numbers). All of the products bear a Pfizer label. Product was distributed Nationwide to distributors, retailers, hospitals, pharmacies, and/or clinics. The product was recalled due to the potential for small black particles, identified as paper shipper labels, to be present in individual vials; the potential for missing lot number and/or expiry date on the outer carton, and the potential for illegible/missing lot number and expiry on individual vials. Intravenous administration of particles may lead to impairment of microcirculation, phlebitis, infection, embolism and subsequent infarction. BACKGROUND: Etomidate is a hypnotic drug indicated for the induction of ge ... Read more

Related support groups: Anesthesia, Etomidate, Amidate

Epidural May Beat Patient-Controlled Painkiller for Childbirth, Study Finds

Posted 3 Feb 2014 by Drugs.com

MONDAY, Feb. 3, 2014 – Epidurals are better pain relievers during labor than patient-controlled doses of a fast-acting painkiller called remifentanil, new research suggests. The Dutch study is scheduled for presentation Friday at the annual meeting of the Society for Maternal-Fetal Medicine in New Orleans. In a meeting news release, study author Dr. Liv Freeman, of Leiden University Medical Center, said pain relief during childbirth was "significantly better" for patients who received epidurals compared to those who received remifentanil. At issue is pain during labor, which often is alleviated through the use of epidural pain relief. The study tested an alternative approach using remifentanil, a short-acting pain reliever, since some studies suggest it works as well as epidurals. Remifentanil works quickly and wears off quickly, according to the Society for Maternal-Fetal Medicine, so ... Read more

Related support groups: Anesthesia

FDA Medwatch Alert: CO2 Multi Absorber by Vital Signs Devices: Field Corrective Action - Loss of Anesthetic Gases, Ventilation and Oxygenation

Posted 3 Jan 2014 by Drugs.com

[Posted 01/01/2014] AUDIENCE: Anesthesiology, Risk Manager ISSUE:  Vital Signs Devices, a GE Healthcare Company, has initiated a voluntary field corrective action of the disposable Multi Absorber Original after becoming aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber.  The Multi Absorber Original may have a thin wall condition which may lead to small holes in the water (drain tube). This may result in a loss of anesthetic gases, ventilation and oxygenation. BACKGROUND:  The voluntary corrective action was issued after receiving customer complaints and product returns; upon further inspection the returned absorbers were found to leak due to a hole in the drain tube. The affected product number is M1173310 containing lot numbers 12001 through 13031. Not affected are products with lot numbers 13032 and higher. RECOMMENDATION: Vital Signs is fo ... Read more

Related support groups: Anesthesia

FDA Medwatch Alert: Lidocaine HCl Injection 2%, 5 ml Vial by Hospira: Recall - Presence of Particulate Matter

Posted 26 Dec 2013 by Drugs.com

ISSUE: Hospira initiated a voluntary nationwide recall to the user level for one lot of Lidocaine HCl Injection, USP, 2%, 5 mL Single-Dose Vial (NDC 0409-2066-05), Lot 32-135-DD, expiration date 1AUG2015. The recall is due to a reddish orange particulate on the inner surface and floating in the solution. If particulate goes undetected and solution is administered, the particle may potentially block the infusion of the solution to the patient, resulting in a delay in therapy. If smaller pieces of the particulate break off and become free floating within the solution, they may pass through the catheter into the patient, resulting in local inflammation or mechanical disruption of tissue. Chronically, following sequestration, local granuloma formulation is possible. In consideration of the reddish orange color of the particulate, if there is iron within the particle that is infused, it may ... Read more

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

Study Questions Safety of Common Anesthesia Drug

Posted 17 Dec 2013 by Drugs.com

TUESDAY, Dec. 17, 2013 – More concern about the safety of a common anesthetic has been raised in a new study. Patients who received the anesthesia drug etomidate during surgery might be at increased risk for cardiovascular problems or death, according to the study, which was published in the December issue of the journal Anesthesia & Analgesia. An accompanying editorial in the journal said the findings add to growing concerns about the use of the drug. The study compared about 2,100 patients who received etomidate and about 5,200 patients who received another intravenous anesthetic called propofol. All of the patients in the study underwent surgery that didn't involve the heart. Compared to those who received propofol, patients who received etomidate had a significantly higher risk of death within 30 days after surgery, according to a journal news release. The risk was 6.5 percent in ... Read more

Related support groups: Anesthesia, Etomidate, Amidate

FDA Medwatch Alert: Low Molecular Weight Heparins: Drug Safety Communication - Recommendations to Decrease Risk of Spinal Column Bleeding and Paralysis

Posted 6 Nov 2013 by Drugs.com

ISSUE: The U.S. Food and Drug Administration (FDA) is recommending that health care professionals carefully consider the timing of spinal catheter placement and removal in patients taking anticoagulant drugs, such as enoxaparin, and delay dosing of anticoagulant medications for some time interval after catheter removal to decrease the risk of spinal column bleeding and subsequent paralysis after spinal injections, including epidural procedures and lumbar punctures. These new timing recommendations, which can decrease the risk of epidural or spinal hematoma, will be added to the labels of anticoagulant drugs known as low molecular weight heparins, including Lovenox and generic enoxaparin products and similar products. BACKGROUND: Epidural or spinal hematomas are a known risk of enoxaparin in the setting of spinal procedures and are already described in the Boxed Warning and the Warnings ... Read more

Related support groups: Anesthesia, Lovenox, Enoxaparin, Clexane, Clexane Forte, Lovenox HP

New Research May Help Spare Patients 'Accidental Awareness' During Surgery

Posted 23 Oct 2013 by Drugs.com

WEDNESDAY, Oct. 23 – A new study offers insight into what happens in the brain when a person is given anesthesia, and the finding could help spare patients the traumatic experience of becoming aware of their own surgery. The British researchers suspect they've found a type of brain activity that marks the point when patients truly go under, and are no longer conscious. If further research confirms that this is the point where people lose awareness, "it may change the way that anesthetics are delivered worldwide," said study co-author Katie Warnaby, a research fellow at the University of Oxford in the United Kingdom. At issue: Patients who aren't fully anesthetized when they undergo an operation or who begin to regain consciousness before the surgery is finished. Physicians believe so-called "accidental awareness" is rare, with one survey of anesthesiologists suggesting that the rate of ... Read more

Related support groups: Surgery, Anesthesia

FDA Medwatch Alert: Vecuronium Bromide For Injection by Sagent Pharmaceuticals, Inc.: Recall - Elevated Impurity Result Detected

Posted 11 Jun 2013 by Drugs.com

ISSUE: Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of three lots of Vecuronium Bromide for Injection 10mg (NDC number 25021-657-10) manufactured by Mustafa Nevzat Ilac Sanayii A.S. (MN Pharmaceuticals) and distributed by Sagent.  Sagent has initiated this voluntary recall of Vecuronium Bromide for Injection to the user level due to the  discovery of an elevated impurity result detected during routine quality testing of stability samples at the 18-month interval. The elevated impurity result has the potential to result in prolonged neuromuscular blockade for critically ill patients with renal failure.  BACKGROUND: Vecuronium Bromide for Injection is a neuromuscular blocking agent indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation and is supplied i ... Read more

Related support groups: Anesthesia, Anesthetic Adjunct, Vecuronium, Norcuron

Secret of Anesthesia Revealed, Study Says

Posted 25 Oct 2012 by Drugs.com

THURSDAY, Oct. 25 – General anesthesia drugs really do put patients to sleep, suggests research conducted in mice. The study found that the drugs don't just turn wakefulness off, they also switch on important sleep circuits in the brain, according to the findings, which were published online Oct. 25 in the journal Current Biology. "Despite more than 160 years of continuous use in humans, we still do not understand how anesthetic drugs work to produce the state of general anesthesia," Dr. Max Kelz, an anesthesiologist at the University of Pennsylvania, said in a journal news release. "We show that a commonly used inhaled anesthetic drug directly causes sleep-promoting neurons to fire," Kelz said. "We believe that this result is not simply a coincidence. Rather, our view is that many general anesthetics work to cause unconsciousness in part by recruiting the brain's natural sleep ... Read more

Related support groups: Anesthesia, Propofol, Ketamine, Diprivan, Isoflurane, Halothane, Nitrous Oxide, Sevoflurane, Droperidol, Etomidate, Fospropofol, Lusedra, Ketalar, Brevital Sodium, Suprane, Fluothane, Ultane, Inapsine, Amidate, Propoven

Survival After General Anesthesia Vastly Improved: Study

Posted 20 Sep 2012 by Drugs.com

THURSDAY, Sept. 20 – The number of people who survive surgery when general anesthesia is used has improved dramatically over the past 50 years, Canadian researchers report. The improvement was noted worldwide, with most of the increases in survival seen in developed countries, the researchers added. Overall, there was a 90 percent drop in such deaths since before the 1970s. "Anesthesia safety continues to improve, and we should continue to find ways to make it even safer," said lead researcher Dr. Daniel Bainbridge, from the department of anesthesia and perioperative medicine at the University of Western Ontario. "We have done a good job to reduce risk of anesthesia," he said. "However, it is similar to the airline industry in that passengers tend to be very concerned about dying while flying, likewise they also are concerned about dying [while] under anesthesia, so the question is ... Read more

Related support groups: Anesthesia, Propofol, Ketamine, Diprivan, Isoflurane, Halothane, Nitrous Oxide, Sevoflurane, Droperidol, Etomidate, Fospropofol, Lusedra, Ketalar, Brevital Sodium, Suprane, Fluothane, Ultane, Inapsine, Amidate, Propoven

Anesthesia Before Age 3 May Raise Risk of Learning Delays: Study

Posted 20 Aug 2012 by Drugs.com

MONDAY, Aug. 20 – Children younger than 3 who have even one surgical procedure requiring general anesthesia may be more likely to have deficits in language and abstract reasoning at age 10, a new study suggests. Australian researchers gave neuropsychological tests to more than 2,600 children; a little more than 300 were exposed to anesthesia before the age of 3 and nearly 2,300 were not. The tests measured language, cognitive function, motor skills and behavior at age 10. Previous studies have relied on parent or teacher assessments, standardized tests and school grades to assess learning delays in children exposed to anesthesia. "Children who were exposed to anesthesia had lower scores in language and abstract reasoning at age 10," said study author Dr. Caleb Ing, a pediatric anesthesiologist at Columbia University College of Physicians and Surgeons in New York City. Even a single ... Read more

Related support groups: Anesthesia, Propofol, Ketamine, Diprivan, Isoflurane, Halothane, Nitrous Oxide, Sevoflurane, Droperidol, Etomidate, Fospropofol, Lusedra, Ketalar, Brevital Sodium, Suprane, Fluothane, Ultane, Inapsine, Amidate, Propoven

FDA Medwatch Alert: Hospira Propofol Injectable Emulsion: Recall - Glass Vial Defect

Posted 17 Aug 2012 by Drugs.com

ISSUE: Hospira and FDA notified healthcare professional of a nationwide recall of three lots of Propofol Injectable Emulsion, 1%, 1g/100 mL, due to visible particles embedded in the glass to the user level. There may be potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution. In the event in which particulate matter could be injected into a patient, there may be the potential for patient injury where medical intervention may be required. Risks associated with this defect could include tissue necrosis in one or more organsthat could result in stroke, myocardial infarction, respiratory failure, and loss of renal and hepatic function. See the Press Release for a listing of affected product lot numbers and expiration dates. BACKGROUND: The product is packaged in vials and indicated for the induction or maintenance of ... Read more

Related support groups: Anesthesia, Propofol, Diprivan, Propoven

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