Help sustain IPSIS's efforts to disseminate vital clinical practice and patient safety information. The International Pain and Spine Intervention Society (IPSIS) is a tax-exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.

By donating, you can help sustain IPSIS's efforts to disseminate vital clinical practice and patient safety information. The International Pain and Spine Intervention Society (IPSIS) is a tax-exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.

By donating, you can help sustain IPSIS's efforts to disseminate vital clinical practice and patient safety information. The International Pain and Spine Intervention Society (IPSIS) is a tax-exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.

By donating, you can help sustain IPSIS's efforts to disseminate vital clinical practice and patient safety information. The International Pain and Spine Intervention Society (IPSIS) is a tax-exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.

By donating, you can help sustain IPSIS's efforts to disseminate vital clinical practice and patient safety information. The International Pain and Spine Intervention Society (IPSIS) is a tax-exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.

The updated labeling change reflects robust data from two large FDA-required observational studies, called postmarketing requirements (PMR) 3033-1 and 3033-2, which recently provided new data on how long-term opioid use can lead to serious side effects. After reviewing those results, public comments, medical research and recognizing the absence of adequate and well-controlled studies on long-term opioid effectiveness, the FDA decided to require safety labeling changes to help health care professionals and patients make treatment decisions rooted in the latest evidence.

The FDA has required an additional prospective, randomized, controlled clinical trial to directly examine the benefits and risks of long-term opioid use. The Agency will be closely monitoring the progress of this clinical trial to ensure its timely completion.

The labeling changes will include the following updates:

• Clearer Risk Information: A summary of study results showing the estimated risks of addiction, misuse, and overdose during long-term use.
• Dosing Warnings: Stronger warnings that higher doses come with greater risks, and that those risks remain over time.
• Clarified Use Limits: Removing language which could be misinterpreted to support using opioid pain medications over indefinitely long duration.
• Treatment Guidance: Labels will reinforce that long-acting or extended-release opioids should only be considered when other treatments, including shorter-acting opioids, are inadequate.
• Safe Discontinuation: A reminder not to stop opioids suddenly in patients who may be physically dependent, as it can cause serious harm.
• Overdose Reversal Agents: Additional information on medicines that can reverse an opioid overdose.
• Drug Interactions: Enhanced warning about combining opioids with other drugs that slow down the nervous system — now including gabapentinoids.
• More Risks with Overdose: New information about toxic leukoencephalopathy — a serious brain condition that may occur after an overdose.
• Digestive Health: Updates about opioid-related problems with the esophagus.
  

The FDA sent letters to the relevant applicants outlining the required changes. The companies will have 30 days to submit their labeling updates to the FDA for review.

More information is available in the FDA’s Drug Safety Communication.

Help sustain this vital dissemination of patient safety information with your donations. The International Pain and Spine Intervention Society (IPSIS) is a tax exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.

• Vial National Drug Code (NDC) 0781-3451-70
• Carton NDC 0781-3451-96
• Lot Numbers PG4360 AND NOW ALSO PG4362
• Expiration Date 2027-NOV.

Risk Statement: There is a reasonable probability that the inadvertent administration of penicillin G potassium injection, instead of intended cefazolin injection, may pose serious and potentially life-threatening adverse health consequences, including lack of efficacy leading to less than optimal treatment of severe infections, antibiotic resistance, adverse reactions, severe allergic reactions (e.g., anaphylaxis), drug interactions, cardiac arrhythmias resulting from high potassium especially in patients with kidney impairment, and delayed recovery. The product being recalled was shipped to select wholesalers for further distribution nationwide. To date, Sandoz has not received any reports of adverse events or injuries related to this recall. Sandoz has received a complaint of inadvertent administration of the incorrect product to a patient.

Background: Cefazolin for Injection USP is used for the treatment of infections caused by certain bacteria in many different parts of the body including the treatment of pneumonia. Cefazolin for Injection USP can also be used to prevent infections, before and after surgery. Antibacterial drugs like Cefazolin for Injection USP treat only bacterial infections. They do not treat viral infections. Cefazolin for Injection USP is indicated for adult, elderly, pediatric patients, including newborn term infants.

Although both Cefazolin and Penicillin G Potassium belong to the beta-lactam group of antibiotics, they are indicated for different types of infections, and the spectrum of susceptible organisms also differs. Additionally, while the patient populations overlap, each medicine has specific on-label distinct groups, and the dosing regimens may differ, as well.

Recommendations: Healthcare providers and customers who have this product should immediately stop use of this lot only and contact Sedgwick, the Sandoz Reverse Distributor, directly by phone at (844) 491-7872 or by email at Sandoz6004@sedgwick.com.

For more information click here. For questions about the recall process, please call Sedgwick at (844) 491-7872.

Report any adverse reactions by calling Sandoz at (800) 525-8747.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

Help sustain this vital dissemination of patient safety information with your donations. The International Pain and Spine Intervention Society (IPSIS) is a tax exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.

SEARCHABLE FACTFINDER PAGE
Need to find a quick answer to a patient safety-related question? Let the comprehensive search feature on the all new IPSIS FactFinder page get you sorted. With a growing library of more than 70 FactFinders, you can now type in your search terms to identify those that will answer your question.

By donating, you help sustain IPSIS's efforts to disseminate vital clinical practice and patient safety information. The International Pain and Spine Intervention Society (IPSIS) is a tax-exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.

• Vial National Drug Code (NDC) 0781-3451-70
• Carton NDC 0781-3451-96
• Lot Number PG4360
• Expiration Date 2027-NOV.
  
  

Risk Statement: There is a reasonable probability that the inadvertent administration of penicillin G potassium injection, instead of intended cefazolin injection, may pose serious and potentially life-threatening adverse health consequences, including lack of efficacy leading to less than optimal treatment of severe infections, antibiotic resistance, adverse reactions, severe allergic reactions (e.g., anaphylaxis), drug interactions, cardiac arrhythmias resulting from high potassium especially in patients with kidney impairment, and delayed recovery. The product being recalled was shipped to select wholesalers for further distribution nationwide. To date, Sandoz has not received any reports of adverse events or injuries related to this recall. Sandoz has received a complaint of inadvertent administration of the incorrect product to a patient.

Background: Cefazolin for Injection USP is used for the treatment of infections caused by certain bacteria in many different parts of the body including the treatment of pneumonia. Cefazolin for Injection USP can also be used to prevent infections, before and after surgery. Antibacterial drugs like Cefazolin for Injection USP treat only bacterial infections. They do not treat viral infections. Cefazolin for Injection USP is indicated for adult, elderly, pediatric patients, including newborn term infants.

Although both Cefazolin and Penicillin G Potassium belong to the beta-lactam group of antibiotics, they are indicated for different types of infections, and the spectrum of susceptible organisms also differs. Additionally, while the patient populations overlap, each medicine has specific on-label distinct groups, and the dosing regimens may differ, as well.

Recommendations: Healthcare providers and customers who have this product should immediately stop use of this lot only and contact Sedgwick, the Sandoz Reverse Distributor, directly by phone at (844) 491-7872 or by email at Sandoz6004@sedgwick.com.

For more information click here. For questions about the recall process, please call Sedgwick at (844) 491-7872.

Report any adverse reactions by calling Sandoz at (800) 525-8747.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

Help sustain this vital dissemination of patient safety information with your donations. The International Pain and Spine Intervention Society (IPSIS) is a tax exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.

The effected non-sterile ultrasound gel products were manufactured by NEXT Medical Products Company of Branchburg, New Jersey:

• MediChoice® lots: 240302, 240306, and
  
• ClearImage® lots: 230221, 230256, 240227, 240230

The CDC continues to investigate and cautions that the use of non-sterile ultrasound gel for percutaneous procedures could result in patient harm — risks not limited to scenarios where there is known product contamination, as microorganisms may be present in non-sterile products in general.

The CDC recommends the following:

• Use only single-use ultrasound gel products labeled as “sterile” for ultrasonography in preparation for or during percutaneous procedures.
• Personnel who perform ultrasounds and ultrasound-associated procedures should be trained in the appropriate use of ultrasound gel products.
• An ultrasound gel product label’s claim of “bacteriostatic” or “preservative” without a specific indication of sterility should be considered “non-sterile” for clinical purposes.

Visit the CDC for additional information and resources.

With your donations, help sustain IPSIS's efforts to disseminate vital clinical practice and patient safety information. The International Pain Spine Intervention Society (IPSIS) is a tax-exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.

Your donations help sustain IPSIS's efforts to assess evidence and promote best practice recommendations. The International Pain and Spine Intervention Society (IPSIS) is a tax exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.

Your donations help sustain IPSIS's efforts to assess evidence and promote best practice recommendations. The International Pain and Spine Intervention Society (IPSIS) is a tax exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.

Read the newest IPSIS systematic review on the effectiveness of balloon kyphoplasty for osteoporotic vertebral compression fractures, published in Interventional Pain Medicine (IPM) — the PubMed Central-indexed official journal of the International Pain and Spine Intervention Society.

Learn more about IPSIS's systematic review development efforts here.

Your donations help sustain IPSIS's efforts to assess evidence and promote best practice recommendations. The International Pain and Spine Intervention Society (IPSIS) is a tax exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.

Find the facts about epidural steroid injections and postoperative infection risk in patients undergoing subsequent lumbar spine surgery. Click here to download this newly updated, free IPSIS FactFinder.

Explore the many other FactFinders at IPSISmed.org/FactFinders.

By donating, you can help sustain IPSIS's efforts to disseminate vital clinical practice and patient safety information. The International Pain and Spine Intervention Society (IPSIS) is a tax-exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.

Find the facts about whether alcohol swabbing of newly opened vial tops is necessary to prevent infection. Click here to download this newly updated, free IPSIS FactFinder.

Explore the many other FactFinders at IPSISmed.org/FactFinders.

By donating, you can help sustain IPSIS's efforts to disseminate vital clinical practice and patient safety information. The International Pain and Spine Intervention Society (IPSIS) is a tax-exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.

Find the facts about whether patients with implanted devices can be safely treated with radiofrequency neurotomy. Click here to download this newly updated, free IPSIS FactFinder.

Explore the many other FactFinders at IPSISmed.org/FactFinders.

By donating, you can help sustain IPSIS's efforts to disseminate vital clinical practice and patient safety information. The International Pain and Spine Intervention Society (IPSIS) is a tax-exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.

Find the facts about whether epidural steroid injections increase a patient’s fracture risk. Click here to download this newly updated, free IPSIS FactFinder.

Explore the many other FactFinders at IPSISmed.org/FactFinders.

By donating, you can help sustain IPSIS's efforts to disseminate vital clinical practice and patient safety information. The International Pain and Spine Intervention Society (IPSIS) is a tax-exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.

Find the facts about whether epidural steroid injections can be safely performed in patients with severe cervical central and neuroforaminal stenosis. Click here to download the new, free IPSIS FactFinder.

Explore the many other FactFinders at IPSISmed.org/FactFinders.

By donating, you can help sustain IPSIS's efforts to disseminate vital clinical practice and patient safety information. The International Pain and Spine Intervention Society (IPSIS) is a tax-exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.

Explore the many other FactFinders at IPSISmed.org/FactFinders.

By donating, you can help sustain IPSIS's efforts to disseminate vital clinical practice and patient safety information. The International Pain and Spine Intervention Society (IPSIS) is a tax-exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.

    
Find the facts about the importance of preprocedural advanced imaging review in minimizing risks when performing cervical transforaminal epidural steroid injections. Click here to download the new, free IPSIS FactFinder.

Explore the many other FactFinders at IPSISmed.org/FactFinders.

By donating, you can help sustain IPSIS's efforts to disseminate vital clinical practice and patient safety information. The International Pain and Spine Intervention Society (IPSIS) is a tax-exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.

    
Find the facts about whether epidural steroid injections can be safely performed in patients with severe, multilevel lumbar spinal stenosis. Click here to download the new, free IPSIS FactFinder.

Explore the many other FactFinders at IPSISmed.org/FactFinders.

By donating, you can help sustain IPSIS's efforts to disseminate vital clinical practice and patient safety information. The International Pain and Spine Intervention Society (IPSIS) is a tax-exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.

    
Find the facts about the safe performance of cervical transforaminal epidural steroid injections. Click here to download the new, free IPSIS FactFinder.

Explore the many other FactFinders at IPSISmed.org/FactFinders.

With your donations, help sustain IPSIS's efforts to disseminate vital clinical practice and patient safety information. The International Pain and Spine Intervention Society (IPSIS) is a tax-exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.

    
Find the facts about the safe performance of cervical transforaminal epidural steroid injections. Click here to download the new, free IPSIS FactFinder.

Explore the many other FactFinders at IPSISmed.org/FactFinders.

With your donations, help sustain IPSIS's efforts to disseminate vital clinical practice and patient safety information. The International Pain and Spine Intervention Society (IPSIS) is a tax-exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.

Find the facts about whether there is an association between epidural steroid injections (ESIs) and the development and/or worsening of spinal epidural lipomatosis (SEL). Click here to download the new, free SIS FactFinder.

Explore the many other FactFinders at IPSISmed.org/FactFinders.

With your donations, help sustain IPSIS's efforts to disseminate vital clinical practice and patient safety information. The International Pain and Spine Intervention Society (IPSIS) is a tax-exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.

• Patients associated with this outbreak should receive immediate testing.
• If fungal meningitis is confirmed, patients should immediately begin treatment.

Visit the CDC’s outbreak web page for additional information and resources.

With your donations, help sustain IPSIS's efforts to disseminate vital clinical practice and patient safety information. The International Pain and Spine Intervention Society (IPSIS) is a tax-exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.