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CDC Health Advisory: Adverse Effects Linked to Counterfeit or Mishandled Botulinum Toxin Injections

View this CDC Health Alert Network (HAN) Health Advisory as a pdfOfficial CDC Health Advisory distributed via the CDC Health Alert Network

April 23, 2024, 11:00 AM ET
CDCHAN-00507

Adverse Effects Linked to Counterfeit or Mishandled Botulinum Toxin Injections

Summary

The Centers for Disease Control and Prevention (CDC) is issuing this Health Alert Network (HAN) Health Advisory to alert clinicians about risks of counterfeit or mishandled botulinum toxin injections. CDC, the U.S. Food and Drug Administration (FDA), and state and local partners are investigating clusters of 22 people in 11 U.S. states reporting adverse effects after receiving injections with counterfeit botulinum toxin or injections administered by unlicensed or untrained individuals or in non-healthcare settings, such as homes or spas. Eleven patients were hospitalized and none have died. When botulinum toxin diffuses around the injection site, it can result in adverse effects. Botulism is the disease caused by botulinum toxin circulating in the blood and producing effects remotely from the injection site. There may be symptom overlap between the presentation of localized adverse effects from injection of botulinum toxin, especially in the head and neck, and the early symptoms of botulism. Information about the botulinum toxin injection (e.g., dose) can help distinguish between botulism and localized adverse effects but is challenging to obtain for counterfeit products. Clinicians and health departments should consider the possibility of adverse effects from botulinum toxin injections in patients presenting with localized paralysis. Clinicians should immediately contact their state, tribal, local, or territorial health department if they suspect botulism.  

Background

Botulism is a rare and sometimes fatal illness caused by botulinum toxin. Initial botulism symptoms may include double or blurred vision, drooping eyelids, slurred speech, difficulty swallowing, and difficulty breathing. These symptoms may be followed by a descending, symmetric muscle weakness that progresses over hours to days. Administration of botulism antitoxin can neutralize toxin circulating in the blood; therefore, treating botulism patients with botulism antitoxin early in the course of disease can prevent the progression of paralysis and consequent complications. Administration of antitoxin is not indicated for local effects of low-dose injections of botulinum toxin preparations, because the low doses of injected toxin are not likely to reach circulation or produce botulism with its life-threatening manifestations.

Some localized paralytic effects, resulting from diffusion of the toxin around the injection site, are expected from botulinum toxin administration. Most individuals with localized symptoms (e.g., dysphagia after injection to the neck) following low-dose cosmetic or therapeutic injections using FDA-approved products will not require treatment with botulism antitoxin. Iatrogenic botulism can occur after cosmetic or therapeutic injections of botulinum toxin when the toxin circulates in the blood and produces effects remotely from the injection site. Iatrogenic botulism is rare; the most recent laboratory-confirmed domestic case occurred in 2017.

As of April 18, 2024, 22 people with adverse effects have been reported in California, Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York City, Tennessee, Texas, and Washington. Symptom onset dates ranged from November 4, 2023, to March 31, 2024. All symptomatic people were females aged 25 to 59 years. All reported receiving botulinum toxin injections by unlicensed or untrained individuals or in non-healthcare settings, including homes or spas. Most (20, 91%) reported receiving botulinum toxin injections for cosmetic purposes.

Among all 22 people, symptoms began a median of 3 days after exposure (range 0 to 20 days) and included symptoms near the injection site (e.g., blurred vision and ptosis after facial injection), dry mouth, slurred speech, shortness of breath, fatigue, and generalized weakness. Of 20 people with information available, 11 (55%) symptomatic people were hospitalized. Six of the 22 symptomatic people received botulism antitoxin to treat suspected botulism. Seven symptomatic people underwent botulinum toxin testing to determine if they had circulating botulinum toxin, which would support a diagnosis of botulism; results were negative for six symptomatic people and are pending for one symptomatic person. Negative results do not rule out botulism as levels of toxin in serum may have fallen below the limit of detection of laboratory tests. None of the 22 symptomatic people met the case definition for botulism, and none have died.

These adverse events have been linked to improper procurement and administration of botulinum toxin. Botulinum toxin should be administered only by licensed providers, using only recommended doses of FDA-approved botulinum toxin, preferably in a licensed or accredited healthcare setting. Providers should be trained in the proper administration of botulinum toxin, practicing in accordance with state and local requirements.

More information about the counterfeit products may be found on FDA’s website.

Recommendations for Clinicians

Diagnosis, consultation, and treatment

  • Consider the possibility of adverse effects from botulinum toxin injections, including those given for cosmetic reasons, in patients presenting with localized paralysis near the injection site.
    • Ask patients about history of botulinum toxin injections, including the dose.
  • Be aware of symptom overlap between the presentation of localized adverse effects from injection of botulinum toxin and the early symptoms of botulism. To help distinguish early botulism symptoms from localized adverse effects:
    • Assess for symmetry of cranial nerve palsies; symmetric cranial nerve palsies are expected with botulism.
    • Assess for progression of cranial nerve palsies, possibly followed by a descending symmetric flaccid paralysis. These should raise suspicion for botulism.  
  • If botulism is suspected, call your health department immediately for consultation. Health departments and health care providers can contact the CDC clinical botulism service 24/7 at 770-488-7100.
  • If public health clinical consultation supports botulism, request antitoxin and begin treatment as soon as it is available. Do not wait for laboratory confirmation to begin treatment.

Clinician reporting

Counseling patients

  • Counsel patients who report using or being interested in using botulinum toxin about potential adverse effects.
  • Advise patients to receive injections only from licensed providers who are trained in proper administration of FDA-approved botulinum toxin products, preferably in a licensed or accredited healthcare setting. 

Recommendations for Laboratories

  • Diagnostic testing for suspected botulism may be done through the CDC National Botulism Laboratory or state public health laboratories.
  • Laboratory confirmation of botulism is done by demonstrating the presence of botulinum toxin in serum through either mouse bioassay or mass spectrometry.
  • Testing varies by state. Contact the CDC clinical botulism service (available 24/7 at 770-488-7100) or your state health department for further guidance on submitting clinical specimens for testing.

Recommendations for Public Health Professionals

  • Health departments should contact the CDC clinical botulism service 24/7 at 770-488-7100 for consultation and antitoxin release.
  • Health departments should report botulism cases to CDC through the National Notifiable Diseases Surveillance System (NNDSS).
  • Contact botsurveillance@cdc.gov for information on how to report adverse effects following administration of unverified or counterfeit botulinum toxin products, by unlicensed or untrained individuals, or in non-healthcare settings such as homes or spas.

Recommendations for the Public

For More Information

References

  1. Halai U, Terashita D, Kim M, et al. Notes from the Field: Intestinal Colonization and Possible Iatrogenic Botulism in Mouse Bioassay-Negative Serum Specimens Los Angeles County, California, November 2017. MMWR Morb Mortal Wkly Rep. 2018;67(43):12211222. doi:10.15585/mmwr.mm6743a6
  2. Rao AK, Sobel J, Chatham-Stephens K, Luquez C. Clinical Guidelines for Diagnosis and Treatment of Botulism, 2021. MMWR Recomm Rep. 2021;70(No. RR-2):1–30.  doi:10.15585/mmwr.rr7002a1
  3. Rao AK, Lin NH, Jackson KA, Mody RK, Griffin PM. Clinical Characteristics and Ancillary Test Results Among Patients With Botulism — United States, 2002–2015. Clin Infect Dis. 2018;66(suppl_1):S4–S10. doi:10.1093/cid/cix935

The Centers for Disease Control and Prevention (CDC) protects people's health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong partnerships with local, national, and international organizations.

COVID-19 Information & Resources

The COVID public health emergency has ended and you can continue to find information and resources below or through the San Bernardino County Department of Public Health at www.sbcovid19.com.

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Bones and Spine Surgery First Outpatient Spine Robot in Inland Empire

Bones and Spine Surgery - The First Outpatient Spine Robot in Inland Empire
FOR IMMEDIATE RELEASE - March 6, 2023

Loma Linda, California – Bones and Spine Surgery is proud to announce the grand opening of our state-of-the-art Loma Linda Surgical Institute featuring the latest surgical technology – An outpatient spine surgery robot.

The new surgery center, located at 25915 Barton Road, Loma Linda, partnered with the prestigious Loma Linda University Faculty Medical Group, is designed to provide a safe and comfortable environment with cutting-edge technology for patients who need same-day surgery. The center has seven operating rooms and provides a wide variety of services such as arthroscopy, joint replacement, minimally invasive spinal surgery, cataract surgery, colonoscopy, endoscopy, and cardiac procedures. 

The surgery robot is the latest advancement in surgical technology, allowing surgeons to perform complex surgeries with precision, accuracy, and minimal invasiveness. It provides a 3D view of the surgical structures by integrating CT scan details with the patient’s own fluoroscopic anatomy for better visualization. It also has incredible accuracy, enabling surgeons to access hard-to-reach areas of the body with ease. With this new technology, patients can expect a faster recovery time, less pain, and minimal scarring.

“We are thrilled to be the first ambulatory surgery centers in Inland Empire to offer this advanced technology,” Wayne Cheng MD., Professor of Orthopedic Surgery and Chairman/Founder of the company “Our goal is to provide patients with the best minimal invasive solution to solve the most complex spinal problems, and this new surgery robot will be one our tool to help us achieve that.”

The grand opening of the new ambulatory surgery center with a surgery robot will take place on March 12, 2023, 1-3 PM, and we invite the media and the public to join us in celebrating this momentous occasion. The event will feature a guided tour of the facility, a demonstration of the surgery robot, and a Q&A session with our expert surgeons.


For more information or to RSVP for the grand opening, please contact ejimenez@bonesandpsine.com.

PHO Message: Notice to Review Ebola Policies and Proceders

Public Health Officer Message:  Notice to Review Ebola Policies and Procedures
December 14, 2022
DOWNLOAD HERE

Dear Healthcare Provider,

As the Ebola virus disease (EVD) outbreak in Uganda continues to evolve, San Bernardino County Department of Public Health (SBCDPH) will share new evidence and updates from CDPH and CDC. Frontline workers, including urgent care and outpatient clinics, are advised to take extreme precautions upon identification of patients with relevant exposure, history, and compatible symptoms to EVD. Immediate isolation of patients and reporting to the SBCDPH in case of a suspected EVD case is critical.

Re-establishing Ebola-specific policies as part of the ongoing strategic planning and readiness should include equipping staff with proper PPE supplies, training and proficiency in donning/doffing protocols, proper waste management, and implementing routine triage screening questions for international travel patients when presenting with symptoms. It is advised that you involve your educators and infection preventionists in updating practices. For further guidance, please refer to the following CDPH guidance.

Individuals who have recently traveled outside of the county and are conveying the following symptoms can indicate a possible EVD case:

  • Fever
  • Severe headache
  • Muscle pain
  • Weakness
  • Fatigue
  • GI complaints: vomiting, diarrhea, and stomach pain
  • Unexplained bleeding (fever and bleeding are not universally present)

SBCDPH is actively tracking at-risk travelers and are working closely with CDPH. The decision to test and/or transfer a patient to a designated treatment center is made in conjunction with Public Health. There are several designated treatment centers for the Southern California region, and others are currently being identified.

Attached with this notice is a copy of a webinar for frontline healthcare facilities hosted by CDPH and Cedars Sinai. Additional education materials can be found on the CDPH website: https:/ /www.cdph.ca.gov/Programs/CID/DCDC/Pages/Ebola VirusDisease.aspx

Sincerely,

Michael A. Sequeira, MD, Health Officer 
San Bernardino County Department of Public Health

Kristy Roloff, D.O. - SBCMS 2022 Nominee for Drs. Larry Tomes & Nutria Pages Commitment to Children Award

Lights For Little Lives, created and sponsored by The Unforgettables Foundation, honors top family doctors and/or pediatricians from the Inland Empire. Winners are selected through SBCMS, RCMA and Children’s Hospital at Loma Linda University.

SBCMS has selected Kristy Roloff, D.O., MS, MPH, FACOG as the “Top Doc” to be recognized by The Unforgettables Foundation for 2022. Dr. Roloff’s work in the area of maternal fetal medicine has had a tremendous positive impact upon the health of infants, pregnant mothers and families, especially those in Medi-Cal populations, in the Inland Empire. Dr. Roloff will be recognized at the Candlelight Walk on Dec. 31, 2022 at Ronald McDonald House at LLU Children’s Hospital.

The Unforgettables Foundation, led by Chaplain Timothy Evans, provides financial assistance to families with limited resources to help offset the costs of providing a dignified  and respectful burial following the death of a child.

CDPH Alert: Severe Monkeypox (MPX) Infection in People w/ Untreated HIV

CDPH Alert - November 08, 2022
Severe Monkeypox (MPX) Infection in People with Untreated HIV and a Weakened Immune System
DOWNLOAD HERE

Dear California Healthcare Providers,

The monkeypox (MPX) outbreak has slowed in California thanks to the leadership of community members, healthcare providers, public health officials, and local health departments. As efforts continue to increase MPX vaccine access, a new CDC report highlights the potential severity of MPX infection in people with a weakened immune system, particularly in those with untreated HIV. The report describes cases of 57 patients hospitalized with severe MPX complications. Twelve of the 57 patients died; the contribution of MPX to death is still under investigation for some cases. Almost all of the severe cases had a severely weakened immune systems, most often related to untreated HIV infection. Most patients were male (95%) and Black (68%), and delays in initiation of MPX treatment of up to 4 weeks were observed.

This CDC report serves as a reminder that consequences of MPX can be severe for immunocompromised people. While new clinical data evolves on the level of protection provided by JYNNEOS vaccine in the current outbreak, vaccination is considered an important intervention to reduce severity of illness. Ensuring people at risk for MPX infection, including all people with HIV, get vaccinated is critical. Healthcare providers should consider prompt MPX treatment with tecovirimat for all patients with probable or confirmed MPX who have severe MPX disease or involvement of anatomic areas which might result in serious sequelae that include scarring or strictures. Additionally, treatment should be considered for patients who are at risk for severe disease, including: pediatric populations (particularly patients younger than 8 years of age), pregnant or breastfeeding people, people with a condition affecting skin integrity, and people currently experiencing severe immunocompromise – especially those with untreated HIV. For more information on treatment and treatment considerations, refer to the CDPH Health Care Professionals page. Healthcare providers are strongly encouraged to test all patients with suspected MPX for HIV and bacterial sexually transmitted infections (STIs) at the time of testing for MPX, as well as provide HIV treatment as soon as possible.

The California Department of Public Health (CDPH) continues to support and work with community stakeholders, local health departments, and healthcare providers to provide
access to MPX vaccine, treatment guidance, and to address disparities in California. To prevent MPX transmission in California, we need to build on our successes to date and address health equity gaps involving access to MPX vaccine and treatment for people to obtain optimal care.

Sincerely,
Tomás J. Aragón, MD, DrPH 
Director and State Public Health Officer
California Department of Public Health

Additional Resources:

Ebola Prepardness for Frontline Webinar - November 12

Ebola Preparedness for California Frontline Healthcare Facilities: Identify, Isolate and Inform Webinar
November 10, 2022 12:00pm-1:00pm
DOWNLOAD FLYER

The California Department of Public Health and Cedars-Sinai Medical Center are pleased to present on Ebola preparedness for California frontline healthcare facilities, including real-world implementation strategies to identify, isolate and inform regarding patients with symptoms and potential exposure to Ebola. Cedars-Sinai will also provide an overview of their capacity as a Regional Special Pathogens Program.

Objectives:

  • Discuss the current Ebola outbreak status in Uganda, returning traveler monitoring, and criteria for a person under investigation (PUI)
  • Understand expectations for frontline healthcare facilities to identify, isolate and inform their local health department regarding patients with symptoms and potential exposure to Ebola
  • Describe real-world implementation strategies for screening and PUI identification
  • Discuss Ebola treatment capacity at Cedars-Sinai Medical Center

Presenters:

  • CDPH
  • Vit Kraushaar, MD │ Medical Epidemiologist, Infectious Diseases Branch
  • Erin Epson, MD │ Chief, Healthcare-Associated Infections Program
  • Cedars-Sinai Medical Center
  • Jennifer Garland RN, PhD, CIC │ Special Pathogens Clinical Program Manager
  • Jennifer Cuzzolina, RN, MSN, CIC │ Special Pathogens Clinical Program Coordinator
  • Jonathan Grein, MD │ Director, Hospital Epidemiology

Primary Audience:

  • Healthcare epidemiologists and infection preventionists, infectious disease physicians, emergency medicine physicians and nurses, clinical laboratory staff at acute care hospitals, other emergency care settings including urgent care clinics, critical access hospitals
  • Local public health communicable disease, public health laboratory, and emergency preparedness staff

Registration Link: reg.learningstream.com/reg/event_page.aspx?ek=0076-0013-21ACC39969034A138FF93EC350B8932D)

For questions, please email HAIprogram@cdph.ca.gov

County of San Bernardino Addresses Surge of Fentanyl Overdoses and Deaths

FOR IMMEDIATE RELEASE - October 17, 2022
Contact:  Francis Delapaz; Communications Officer; (909) 520-5103; Francis.Delapaz@dph.sbcounty.gov

San Bernardino County’s Public Health Officer has issued a health advisory to bring attention to the dangers of fentanyl due to a marked increase of overdose deaths in the county. Health advisories are issued to raise public awareness when a significant threat to public health is identified, along with recommendations to eliminate or mitigate the risk.

In 2018, there were 30 fentanyl overdose deaths in the county. The number rose to 74 residents in 2019, and then to 227 in 2020. Last year, there were 309 fentanyl overdose deaths in the county.

Several County agencies – Public Health, Sheriff, District Attorney, Behavioral Health, County Superintendent of Schools, and Arrowhead Regional Medical Center – are collaborating with community-based organizations, healthcare providers, and schools to develop strategies to raise awareness and identify solutions to reduce fentanyl use.

“Deaths related to opioid use, such as fentanyl, are completely preventable,” said the County’s Health Officer Dr. Michael Sequeira. “Efforts to reduce the effects of opioid overdose and death are a top priority for San Bernardino County.”

Sequeira is also warning people to be aware of the emergence of “rainbow fentanyl,” which is a potentially fatal drug found in pills and powders in a variety of bright colors, shapes and sizes that could be attractive to young people.

According to the Centers for Disease Control and Prevention, fentanyl is a cheap synthetic drug 50 to 100 times stronger than morphine and is responsible for more overdose deaths than any other illegal drug in the United States. It is a major contributor to fatal and nonfatal overdoses in the United States. Fentanyl’s increased presence in the drug supply is a key contributor to the increase in overdose deaths.

Many illegal drugs, including counterfeit prescription opioid pills, heroin, cocaine, methamphetamine, and ecstasy, can be mixed with fentanyl with or without a person’s knowledge, as they would not be able to see, taste, or smell the fentanyl.

The Department of Public Health is working on implementing various strategies to protect the community, including:

  • Increasing the availability and accessibility of Naloxone. Naloxone is a life-saving medication that can reverse an overdose from opioids—including heroin, fentanyl, and prescription opioid medications—when given in time.
  • Integrating harm reduction intervention services in the community. Harm reduction emphasizes engaging directly with people who use drugs to prevent overdose and connect them to support services.
  • Providing opioid awareness and overdose prevention education.

Anyone who encounters fentanyl in any form should not handle it and should call 911 immediately.

Recognizing the signs of opioid overdose can save a life. Here are some things to look for:

  • Small, constricted “pinpoint pupils”
  • Falling asleep or losing consciousness
  • Slow, weak, or no breathing
  • Choking or gurgling sounds
  • Limp body
  • Cold and/or clammy skin
  • Discolored skin (especially in lips and nails)

To learn more about how Public Health is working to address the opioid epidemic, visit https://wp.sbcounty.gov/dph/programs/health-edu/opioid-initiative.  For information about alcohol/substance use treatment options, call the Department of Behavioral Health Substance Use Disorder 24-hour helpline at (800) 968-2636.  Help is a phone call away.

Updated COVID-19 Vaccines Providing Protection Against Omicron Variant Available at No Cost

The Department of Health & Human Services (HHS), through CMS announced that people with Medicare, Medicaid, Children’s Health Insurance Program coverage, private insurance coverage, or no health coverage can get COVID-19 vaccines, including the updated Moderna and Pfizer-BioNTech COVID-19 vaccines, at no cost, for as long as the federal government continues purchasing and distributing these COVID-19 vaccines.

The FDA has authorized the Moderna and Pfizer-BioNTech updated vaccines that target the original COVID-19 viral strain and two Omicron variants (BA.4/BA.5) that are currently the most prevalent in the U.S. Individuals are eligible for their updated vaccine shot at least two months after completing at least their primary vaccination series (two doses of Pfizer-BioNTech, Moderna, or Novavax, or one dose of Johnson & Johnson)—regardless of how many monovalent COVID-19 boosters they have received to date.

CMS issued 4 new CPT codes effective August 31, 2022:

Code 91312 for Pfizer-BioNTech COVID-19 Vaccine, Bivalent Product:

  • Long descriptor: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, bivalent spike protein, preservative free, 30 mcg/0.3 mL dosage, tris-sucrose formulation, for intramuscular use
  • Short descriptor: SARSCOV2 VAC BVL 30MCG/0.3ML

Code 91313 for Moderna COVID-19 Vaccine, Bivalent Product:

  • Long descriptor: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, bivalent, preservative free, 50 mcg/0.5 mL dosage, for intramuscular use
  • Short descriptor: SARSCOV2 VAC BVL 50MCG/0.5ML

Code 0124A for Pfizer-BioNTech COVID-19 Vaccine, Bivalent - Administration – Booster Dose:

  • Long descriptor: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, bivalent spike protein, preservative free, 30 mcg/0.3 mL dosage, tris-sucrose formulation, booster dose
  • Short descriptor: ADM SARSCV2 BVL 30MCG/.3ML B

Code 0134A for Moderna COVID-19 Vaccine, Bivalent - Administration – Booster Dose:

  • Long descriptor: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, bivalent, preservative free, 50 mcg/0.5 mL dosage, booster dose
  • Short descriptor: ADM SARSCV2 BVL 50MCG/.5ML B

Visit the COVID-19 Vaccine Provider Toolkit for more information, and get the most current list of billing codes, payment allowances, and effective dates. Note: You may need to refresh your browser if you recently visited their webpage.

See the full news alert.