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Anesthesia News

FDA Medwatch Alert: PharMEDium Sterile Preparations Compounded With a Single Recalled Lot of Fresenius Kabi Sensorcaine-MPF (bupivacaine HCl): Recall - Presence of Glass Particulate Matter

Posted 20 days ago by Drugs.com

[Posted 05/09/2016] Fresenius Kabi indicated in its recall notice that the presence of glass particulate matter in solution, if undetected and administered via the epidural route, could block drug administration, delaying therapy. If the particulate is able to pass through the catheter and enter the body, this could result in local inflammation, mechanical disruption of tissue or cause an immune response to the particulate. BACKGROUND: The drug products affected by this recall are indicated for the production of local or regional anesthesia or analgesia for surgery procedures, diagnostic and therapeutic procedures and for obstetrical procedures. The product was distributed to hospital customers and acute surgery centers in the United States. RECOMMENDATION: PharMEDium Services has contracted with Inmar Pharmaceutical Services to coordinate this recall. Inmar will send notification via ... Read more

Related support groups: Anesthesia, Sensorcaine-MPF

Flamel Technologies Receives FDA Approval of Akovaz (ephedrine sulfate) for Surgical Hypotension

Posted 3 May 2016 by Drugs.com

LYON, FRANCE--(Marketwired - May 2, 2016) - Flamel Technologies (NASDAQ: FLML) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's New Drug Application (NDA) for Akovaz™ (ephedrine sulfate), a drug administered parenterally as a pressor agent to address clinically important hypotension in surgical settings. Flamel obtained NDA approval for Akovaz as scheduled on April 29 and is the first to receive approval from the FDA for ephedrine sulfate. Flamel expects to launch Akovaz during the third quarter 2016 in a strength of 50 mg/mL. "We are very excited to receive FDA approval for Akovaz, the third product from our Éclat portfolio, and in line with the PDUFA date expectations. Revenue expectations associated with this product were included in our previously issued 2016 revenue guidance of $110 - $130 million. Our Éclat portfolio of products, which in ... Read more

Related support groups: Surgery, Anesthesia, Hypotension, Ephedrine, Akovaz

Men, Avoid Impotence Drugs Before Surgery

Posted 21 Mar 2016 by Drugs.com

MONDAY, March 21, 2016 – Men should not take erectile dysfunction drugs such as Viagra and Cialis just before surgery, experts say. The drugs contain nitric oxide, which opens blood vessels and relaxes muscles. This can cause a patient's blood pressure to become dangerously low when combined with anesthesia and other drugs used during surgery, according to the American Association of Nurse Anesthetists (AANA). The group advises men not to take Viagra or Cialis the day before surgery because the drugs take more than 24 hours to clear the body. It's also important for men to inform the person administering their anesthesia about their use of erectile dysfunction drugs. "Patients should never feel embarrassed about telling their anesthesia professional that they use these products," Juan Quintana, AANA president, said in a new release from the association. "Anesthesia professionals need ... Read more

Related support groups: Surgery, Viagra, Erectile Dysfunction, Cialis, Levitra, Anesthesia, Sildenafil, Tadalafil, Staxyn, Revatio, Vardenafil, Adcirca

'Preemie' Babies May Face Long-Term Anesthesia Risks

Posted 25 Feb 2016 by Drugs.com

THURSDAY, Feb. 25, 2016 – Children born prematurely may be at risk for complications from anesthesia and sedation at least into young adulthood, a new study suggests. "Perhaps we should look at these children differently and provide different care to them," said study lead author Dr. Jeana Havidich, a pediatric anesthesiologist at Dartmouth-Hitchcock Medical Center in Lebanon, N.H. Premature babies often face medical issues that require diagnostic tests and procedures, even as they grow older, the study noted. And physicians know prematurity puts these people at higher risk when they need to be sedated, Havidich said. "We have a sense of heightened awareness, a gut feeling that these children are more challenging to manage," she added. But it's not clear, she said, at what point that risk goes away. The new study attempted to answer that question. The researchers examined the medical ... Read more

Related support groups: Anesthesia, Light Sedation, Premature Labor, Prematurity/Underweight in Infancy, Light Anesthesia, Reversal of Anesthesia, Bronchospasm During Anesthesia, Postanesthetic Shivering

Minds of Older Women Fuzzier After General Anesthesia Than Men's

Posted 21 Jul 2015 by Drugs.com

TUESDAY, July 21, 2015 – Older women are much more likely than men to suffer brain dysfunction after surgery with general anesthesia, a new study finds. Researchers who analyzed data from hundreds of older adults in the United States found faster declines in mental function and brain volume for both women and men who had surgery with general anesthesia compared to those who had no surgery. But the long-term decline was much greater in women than in men. The mental fall-off was especially severe among women who had multiple surgeries with general anesthesia, the researchers said. "This is one of the first studies to suggest that among older adults, women are at a higher risk for postoperative brain dysfunction than men," study author Dr. Katie Schenning of Oregon Health & Science University, said in an association news release. "Our research clearly shows an association between surgery, ... Read more

Related support groups: Anesthesia, Light Sedation, Mild Cognitive Impairment, Light Anesthesia

More Evidence That General Anesthesia May Affect Young Brains

Posted 8 Jun 2015 by Drugs.com

MONDAY, June 8, 2015 – Having general anesthesia during surgery at a very young age may be linked to poorer brain development, new research suggests. Children who had received general anesthesia during surgery before they turned 4 years of age later scored slightly lower on listening comprehension and parts of an IQ test, compared to children who had never had general anesthesia, the researchers found. The children's overall IQ scores, however, remained within the normal range. "It is difficult to see whether this decrease had any functional effect for an individual child," said study author Dr. Andreas Loepke, a professor of clinical anesthesia and pediatrics at the University of Cincinnati College of Medicine. But, he added, "these concerns make it obvious that a lot more research is needed to better understand the effects of anesthetics on brain development." The findings, published ... Read more

Related support groups: Surgery, Anesthesia

Anesthesia Complications Drop by Half, Study Finds

Posted 12 Oct 2014 by Drugs.com

SUNDAY, Oct. 12, 2014 – Anesthesia-related complications in the United States have fallen by more than half, while the overall death rate has remained the same, a new study indicates. Researchers analyzed data from more than 3.2 million cases of anesthesia use between 2010 and 2013, and found the rate of complications decreased from 11.8 percent to 4.8 percent. The most common minor complication was nausea and vomiting (nearly 36 percent) and the most common major complication was medication error (nearly 12 percent). "Our goal was to determine the nature and incidence of surgical complications at the national level and to identify their risk factors," study author Dr. Jeana Havidich, an associate professor of anesthesiology at Dartmouth-Hitchcock Medical Center in New Hampshire, said in an ASA news release. "Previous studies examined adverse events for specific surgical procedures, ... Read more

Related support groups: Anesthesia, Propofol, Ketamine, Diprivan, Nitrous Oxide, Sevoflurane, Isoflurane, Halothane, Droperidol, Pentothal, Etomidate, Amidate, Thiopental, Lusedra, Ultane PEN, Methohexital, Ketalar, Brevital Sodium, Desflurane, Enflurane

Rely on Mom-to-Be When Epidural Is Needed

Posted 9 Oct 2014 by Drugs.com

THURSDAY, Oct. 9, 2014 – When it comes to pain relief during labor and delivery, mom probably knows best, new research suggests. Doctors tend to be cautious about when to give the pain-relieving local anesthetic known as an epidural during labor. But, a new study says the best time to give an epidural is likely when a woman asks for it. Researchers reviewed nine studies that included more than 15,000 first-time mothers randomly assigned to receive an epidural either early or late during childbirth. Those given early epidurals were less than 4 to 5 centimeters dilated, while those given late epidurals were 4 to 5 centimeters or more dilated. In a normal vaginal delivery, the baby is delivered after the woman's cervix is dilated to 10 centimeters, according to the American Pregnancy Association. Compared to women who had late epidurals, those who had early epidurals were no more likely ... Read more

Related support groups: Anesthesia, Labor Pain

FDA Medwatch Alert: Lidocaine HCl Injection, USP, 2 percent, by Hospira: Recall - Visible Particulates

Posted 30 Jul 2014 by Drugs.com

ISSUE: Hospira, Inc. is recalling one lot of Lidocaine HCl Injection, USP, 2%, 20 mg per mL, 5 mL single-Dose Vial, Preservative-Free (NDC 0409-2066-05; Lot 25-550-DD, Expiry 1JAN2015) to the user level due to a confirmed customer report of discolored product with visible particles in the solution as well as particulate embedded in the molded glass container. Hospira has identified the particulate as iron oxide. Risk factors associated with the particulate include the potential for particulate to be injected and/or a delay in therapy. 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. Particulates may be able to pass through the catheter and may result in local inflammation, mechanical disruption of tissue or immune response to the particulate. ... Read more

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

FDA Approves Ryanodex for the Treatment of Malignant Hyperthermia

Posted 23 Jul 2014 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, Bupivacaine, Marcaine, Marcaine HCl, Sensorcaine, Marcaine Spinal, 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

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Sedation, Light Sedation, Light Anesthesia, Local Anesthesia, Anesthetic Adjunct, Reversal of Nondepolarizing Muscle Relaxants, Reversal of Sedation, Reversal of Neuromuscular Blockade, Postanesthetic Shivering, Coma Induction, Bronchospasm During Anesthesia, Reversal of Anesthesia

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