Skip to Content

Join the 'Bupivacaine' group to help and get support from people like you.

Bupivacaine News

FDA Medwatch Alert: 0.25 Percent Bupivacaine Hydrochloride Injection, USP by Hospira: Recall - Particulate Matter

Posted 8 Aug 2016 by Drugs.com

ISSUE: Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of 0.25% Bupivacaine Hydrochloride Injection, USP (NDC: 0409-1159-02, Lot 59-064- DK, Expiry 1NOV2017) at the hospital/retail level due to the presence of particulate matter within a single vial. In the event that the particulate is administered to a patient, it may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response to the particulate. BACKGROUND: 0.25% Bupivacaine Hydrochloride Injection, USP is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. The product is packaged 50 units of 30 mL Single-use Teartop Vials per case, (25 Bottles per tray, two trays per case). The lot was distributed nationwide in ... Read more

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

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, Light Sedation, Xylocaine, Local Anesthesia, Bupivacaine, Marcaine, Novocain, Diprivan, Procaine, Septocaine, Nitrous Oxide, Anesthetic Adjunct, Sevoflurane, Mepivacaine, Tetracaine, Isoflurane, Prilocaine

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

Local Anesthesia May Be Best for Infants During Surgery

Posted 14 May 2015 by Drugs.com

THURSDAY, May 14, 2015 – New research suggests infants may recover better after some kinds of surgery if they receive local anesthesia – which only numbs part of the body – instead of being "knocked out" completely with general anesthesia. Young patients who had local anesthesia were less likely to suffer from disrupted breathing following hernia surgery, the study found. "Our research provides the strongest evidence to date on how babies should have anesthesia for hernia repair, the most common procedure among infants," said lead author Dr. Andrew Davidson, an associate professor at Royal Children's Hospital in Melbourne, Australia. "We found that spinal [local] anesthesia is safer than general anesthesia," Davidson explained in a news release from the American Society of Anesthesiologists. There's long been uncertainty about the use of general anesthesia in infants and toddlers. ... Read more

Related support groups: Surgery, Lidocaine, Xylocaine, Bupivacaine, Marcaine, Novocain, Septocaine, Procaine, Prilocaine, Mepivacaine, Tetracaine, Marcaine HCl, Exparel, Epinephrine/Lidocaine, Marcaine Spinal, Articaine/Epinephrine, Carbocaine, Naropin, Bupivacaine/Epinephrine, Chirocaine

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

Risks From Epidural, Spinal Anesthesia Very Low, Study Says

Posted 15 Oct 2014 by Drugs.com

TUESDAY, Oct. 14 2014 – The risks of using epidural and spinal anesthesia during childbirth are extremely low, according to a new study. Researchers analyzed data from more than 80,000 women who received epidural or spinal anesthesia during childbirth and found that the overall rate of complications was just under 3 percent. The most common complications involved medications, including receiving too much or too little anesthesia, or being given unintended or expired medications. The fear of "spinal headache" is common among women about to receive epidural or spinal anesthesia, but this complication – formally known as a post-dural puncture headache – occurred in only 0.2 percent of patients, according to the study. The findings are scheduled for presentation Tuesday at the annual meeting of the American Society of Anesthesiologists in New Orleans. "The rates of complications are ... Read more

Related support groups: Lidocaine, Xylocaine, Bupivacaine, Marcaine, Novocain, Procaine, Septocaine, Labor Pain, Mepivacaine, Tetracaine, Prilocaine, Marcaine HCl, Exparel, Marcaine Spinal, Carbocaine, Naropin, Chirocaine, Sensorcaine, Epinephrine/Lidocaine, Polocaine

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, Sensorcaine-MPF Spinal

FDA Medwatch Alert: Hospira brand Lidocaine and Marcaine: Recall - Presence Of Particulate

Posted 23 Oct 2013 by Drugs.com

UPDATED 10/21/2013 with related product recall information Hospira announced a voluntary nationwide recall to the user level for one lot of 0.25% Marcaine (Bupivacaine HCl Injection, USP), 75 mg/30 mL, Single-dose Vial – Preservative Free (NDC 0409-1559-30), Lot 25-220-DD. The recall is due to a confirmed customer report of discolored solution with visible particles inside the glass vial as well as embedded in the glass. See firm's press release below for further information. [Posted 10/04/2013] AUDIENCE: Health Professional, Risk Manager ISSUE: Hospira, Inc. announced it has initiated a voluntary nationwide recall of one lot of 1% Lidocaine HCI Injection, USP, 10 mg/mL, 20 mL Multiple-dose Fliptop Vial, NDC 0409-4276-01 Lot 25-090-DK (the lot number may be followed by 01 or 02). This action is due to one confirmed customer report of visible particulate, identified in the primary con ... Read more

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

Combo Treatment Might Beat Epidural to Ease Labor: Study

Posted 5 Mar 2013 by Drugs.com

TUESDAY, March 5 – In the first stage of labor, a combined spinal-epidural technique provides faster and better pain relief compared to traditional epidural pain relief, a new study suggests. The research included 800 healthy women who required pain relief during childbirth, and who were divided into two groups. One group received standard epidural pain relief, which involves injections of local anesthetic and pain medications into the epidural space, inside the membranes covering the spinal cord. The other group received the combination approach, which starts with medications injected into the intrathecal space, the deeper space directly around the spinal cord, before using an epidural injection. After the initial epidural or intrathecal injections, both groups received patient-controlled epidural analgesia. The effectiveness of pain relief, rated on a 0-to-10 scale, was compared at ... Read more

Related support groups: Lidocaine, Xylocaine, Bupivacaine, Marcaine, Novocain, Procaine, Septocaine, Labor Pain, Mepivacaine, Tetracaine, Prilocaine, Marcaine HCl, Exparel, Marcaine Spinal, Carbocaine, Naropin, Chirocaine, Sensorcaine, Epinephrine/Lidocaine, Polocaine

Pacira Pharmaceuticals, Inc. Announces U.S. FDA Approval of Exparel For Postsurgical Pain Management

Posted 31 Oct 2011 by Drugs.com

PARSIPPANY, N.J., Oct. 31, 2011 /PRNewswire via COMTEX/ – Pacira Pharmaceuticals, Inc. announces that the U.S. Food and Drug Administration (FDA) has approved Exparel (bupivacaine liposome injectable suspension) 1.3% for administration into the surgical site to produce postsurgical analgesia. In a pivotal hemorrhoidectomy trial of Exparel compared to placebo, where all patients with inadequate pain control received opioids for rescue pain relief, Exparel demonstrated significant reductions in cumulative pain scores with an attendant decrease in opioid consumption for up to 72 hours. "As a non-opioid local analgesic, Exparel represents an evolution in the management of postsurgical pain by providing analgesia for several days with a single intraoperative infiltration," said Dave Stack, president and CEO of Pacira Pharmaceuticals, Inc. "This FDA approval is an important milestone for ... Read more

Related support groups: Pain, Postoperative Pain, Bupivacaine

Hypnosis Plus Local Anesthesia Might Work Well for Some Surgeries

Posted 14 Jun 2011 by Drugs.com

TUESDAY, June 14 – Certain surgeries that typically require the use of general anesthesia could be safely performed with localized anesthesia in combination with hypnosis, Belgian researchers suggest. The finding stems from a pair of very small case-control studies that explored the combo's potential during surgical procedures performed for breast cancer patients and thyroid patients, respectively. The studies revealed that, relative to general anesthesia, the local anesthesia/hypnosis approach sped up the healing process, reduced the need for post-surgery opioid drugs and reduced hospitalization time. "There is still a lot of debate around the exact mechanism that allows hypnosis to reduce pain perception," said study author and professor Fabienne Roelants in a European Anaesthesiology Congress news release, "but what is absolutely clear is that it does so." She and her colleague ... Read more

Related support groups: Surgery, Lidocaine, Xylocaine, Bupivacaine, Marcaine, Novocain, Septocaine, Procaine, Prilocaine, Mepivacaine, Tetracaine, Marcaine HCl, Epinephrine/Lidocaine, Marcaine Spinal, Articaine/Epinephrine, Carbocaine, Naropin, Bupivacaine/Epinephrine, Chirocaine, Sensorcaine

Ask a Question

Further Information

Related Condition Support Groups

Local Anesthesia, Postoperative Pain, Cesarean Section

Related Drug Support Groups

Marcaine, Marcaine HCl, Sensorcaine, Marcaine Spinal, Sensorcaine-MPF, Sensorcaine-MPF Spinal

Bupivacaine Patient Information at Drugs.com