A deadly drug — sometimes in disguise
Introduced more than 50 years ago, pharmaceutical fentanyl is a man-made opioid sometimes prescribed to treat severe and/or chronic pain.1,2 But this isn’t the kind of fentanyl you’re hearing about in the news these days. Illicitly manufactured fentanyl, the illegal form of the drug, is up to 50 times stronger than heroin.3 It’s also believed to be the main reason for the recent spike in opioid overdose deaths in the US.3,4
No one plans to come face to face with a deadly opioid overdose situation, but it happens every day.3 Be prepared to save a life and carry a life-saving naloxone medication like Kloxxado® (naloxone HCl) nasal spray 8 mg.5
Dangers of illicitly manufactured fentanyl
The surge of illicitly manufactured fentanyl flooding this country is driving a lethal new phase of the US opioid epidemic.1 And it takes just a tiny bit to end someone’s life. Just 2 mg of fentanyl – the amount shown in the photos below – has the potential to cause a deadly overdose.5
As fatal overdoses reach record-breaking levels, it is important to remember that each one of us has the power to potentially save another person from a deadly fentanyl-related overdose.1-3,6 How? By being prepared for an opioid overdose emergency and carrying a lifesaving naloxone medication like Kloxxado® (naloxone HCl) nasal spray 8 mg.6
A lethal dose of illicitly manufactured fentanyl
The images above are used with permission from the United States Drug Enforcement Administration (US DEA).5
Counterfeit, contamination and the future of illicit opioids
Counterfeit pills
Criminal drug networks are mass producing and distributing “fake pills”—counterfeits of prescription opioids such as oxycodone (Oxycontin®, Percocet®), hydrocodone (Vicodin®), antianxiety medicines like alprazolam (Xanax®) and stimulants/amphetamines (Adderall®)—with the intention of deceiving the American public.7
Think you can’t be fooled? See if you can tell the difference between the real and counterfeit prescription drugs below.7
Oxycodone (eg, OxyContin®)
Alprazolam (eg, Xanax®)
Stimulant (eg, Adderall®)
The images above are used with permission from the United States Drug Enforcement Administration (US DEA).7
These are just examples and do not represent the endless varieties of fake pills currently available. Never trust your own eyes to confirm that a pill is legitimate. The only safe medications are those prescribed by your doctor and dispensed by a licensed pharmacy in a container with your name on it.7
Fentanyl contamination
Drug dealers also sometimes mix fentanyl in with other illicit drugs, like cocaine and methamphetamine and other stimulants, without the user’s knowledge.3,8 Some of them do this not only to “stretch” their inventory, but also to create a final product that is more addictive.9 This means that all drugs are potentially deadly because they could contain lethal amounts of fentanyl.3,8,9 According to the Centers for Disease Control and Prevention, more than 150 people die each day from overdoses where synthetic opioids like fentanyl were involved.3
The DEA Laboratory recently found that, of the fentanyl-laced fake prescription pills analyzed in 2022, 6 out of 10 contain a potentially lethal dose of fentanyl.7
The next wave of illicit opioids
Fentanyl overdose
Fentanyl is one of the most common drugs involved in overdose deaths.3 It takes up less space than other opioids (like heroin), so it’s easier to smuggle and transport.5 You can’t see it, taste it or smell it, so fentanyl contamination in both opioids and non-opioids is virtually impossible to detect.3 In a recent string of 500 suspected fentanyl poisonings in St. Louis, for example, more than half of the people did not know what they were taking.18
Taking an illicit substance without knowing if it contains fentanyl or not is risky, to say the least. Adding to the danger is how quickly fentanyl can cause an overdose.19 Unlike a heroin overdose, during which a bystander might have as long as 3 hours to administer naloxone and revive the person, fentanyl poisoning can set in within seconds to minutes.19,20
For people taking prescription fentanyl, overdose risk factors include not taking it as prescribed (such as taking it at higher doses or using it more frequently than needed).21
Other risk factors for fentanyl overdose include:21
- Mixing fentanyl with other illicit substances, such as benzodiazepines, alcohol, cocaine and methamphetamine
- Past history of fentanyl overdose
- Taking fentanyl again after a short period of not taking it
- Low or no tolerance to opioids
- Combining fentanyl with certain prescription drugs, including prescription opioids
- Purchasing and using illicitly manufactured fentanyl
- Using a substance that may contain fentanyl without others nearby to intervene, if needed
Who Should Carry Kloxxado®
Wondering if naloxone should be part of your first aid kit? This checklist will help you decide.
Kloxxado® and synthetic opioid overdose reversal
Because fentanyl is so powerful, an overdose can set in within minutes or even seconds.19 Overdose reversals with fentanyl also often tend to involve multiple doses of naloxone.19,23 As in all cases of opioid overdose, it’s important to reverse the effects of the drug and get the person breathing again as quickly as possible.24 Average time for EMS to arrive on the scene is 7 minutes, but permanent brain damage can occur after just 4 minutes without oxygen.24,25
Overdoses involving increasingly powerful opioids like fentanyl, fentanyl analogs and nitazenes may call for a stronger form of naloxone. Kloxxado® (naloxone HCl) nasal spray 8 mg delivers twice as much naloxone per dose as Narcan® (naloxone HCl) Nasal Spray 4 mg.6,26
During an opioid overdose, every moment matters. Whether you are concerned about a loved one who suffers with substance use disorder or have children or teens who might be influenced to experiment with drugs, it’s time to talk about synthetic opioids and Kloxxado®.6
How to use Kloxxado®
Anyone can administer Kloxxado® in just 4 steps:6
Once Kloxxado® has been given, call 911. Kloxxado® nasal spray is not a substitute for emergency medical care.6
Ideally, emergency medical services (EMS) will arrive before a second dose of Kloxxado® is needed. If the victim has not responded after a few minutes and EMS still has not arrived, however a second dose of Kloxxado® may be necessary. This might happen in the case of a fentanyl overdose, or if the naloxone wears off before the opioids do.6
You can administer additional doses of Kloxxado® every 2 or 3 minutes (in alternating nostrils) if the overdose victim does not respond, responds insufficiently or loses consciousness.6
Kloxxado® Patient Brochure
Read about the key benefits of Kloxxado® nasal spray.
Fentanyl and overdose FAQs
Naloxone, the medicine in Kloxxado®, works only if a person has opioids in their system.*† It has no effect if opioids are not present.† Administering naloxone is unlikely to harm someone, but it could save their life if they are experiencing an opioid overdose.†
* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021
† Access to Naloxone Can Save a Life During an Opioid Overdose. US Food and Drug Administration website. Available at: https://www.fda.gov/consumers/consumer-updates/access-naloxone-can-save-life-during-opioid-overdose. Accessed March 5, 2023.
If you or someone you love is at risk for misusing opioids, resources and help are available. Find information about substance use disorder treatment options on findtreatment.gov, a product of the Substance Abuse and Mental Health Services Administration. Connect with harm reduction resources near you at harmreduction.org, the official website of the National Harm Reduction Coalition.
Across Kloxxado® nasal spray’s two pharmacokinetics (PK) studies, adverse reactions were reported in two subjects for each of the following: abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope.*
Risks include: Risk of Recurrent Respiratory & CNS Depression; Risk of limited efficacy with partial agonists or mixed agonist/antagonists; Precipitation of severe opioid withdrawal; Risk of CV effects.*
For more information, please see the full Prescribing Information and Important Safety Information.
To report an adverse event or product complaint, please contact us at us.hikma@primevigilance.com or call 1-877- 845-0689 or 1-800-962-8364. Adverse events may also be reported to the FDA directly at 1-800-FDA-1088 or www.fda.gov/medwatch.
* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021
Kloxxado® nasal spray is administered in the nostril and does not require evidence of breathing through the nose during administration.*
Opioids work by attaching to specific receptors found in the brain and in the nervous system.† This includes the nerves that sense pain, as well as the nerves that control breathing.† Taking too many opioids can lead to an overdose and that can stop someone from breathing.†
Naloxone, the active ingredient in Kloxxado®, stops the opioids from attaching to the receptors on the nerves.* This reverses the effects and symptoms of the overdose.*‡
Get emergency medical help right away in any case of known or suspected overdose emergency. Kloxxado® nasal spray is not a substitute for emergency medical care.* Administer in accordance with the instructions provided in the Kloxxado® Quick Instructions for Use.
Each device is a single dose.* If an additional dose is needed, you must use another device.*
* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021.
† White JM & Irvine RJ. 1999, “New Horizons/Mechanisms of fatal opioid overdose,” Addiction, 94(7):961–972.
‡ NIDA 2021. “Naloxone DrugFacts,” National Institute on Drug Abuse, https://www.drugabuse.gov/publications/drugfacts/naloxone, Accessed May 3, 2021.
Kloxxado® is a nasal spray that contains a single spray with 8 mg of naloxone HCl.* Kloxxado® can be used by anyone to reverse the effects of an opioid overdose until medical help arrives.* Each box of Kloxxado® contains two individually packaged single-spray devices.*
Always carry Kloxxado® with you in case of an opioid emergency.
* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021
Facing Fentanyl Now
Learn how families are working together to help their kids be safe from illicit fentanyl poisoning.
References
- Stanley TH. The Fentanyl Story. J Pain. 2014;15(12):1215-1226.
- Fentanyl DrugFacts. National Institute on Drug Abuse website. Available at: https://nida.nih.gov/publications/drugfacts/fentanyl. Accessed March 21, 2023.
- Fentanyl Facts. Centers for Disease Control and Prevention website. Available at: https://www.cdc.gov/stopoverdose/fentanyl/index.html. Accessed March 21, 2023.
- Prescription Behavior Surveillance System (PBSS) Issue Brief. Centers for Disease Control and Prevention website. Available at: https://www.cdc.gov/drugoverdose/pdf/pbss/PBSS-Report-072017.pdf. Accessed March 30, 2023.
- Facts about Fentanyl. US Drug Enforcement Administration website. Available at: https://www.dea.gov/resources/facts-about-fentanyl. Accessed March 21, 2023.
- Kloxxado® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021.
- One Pill Can Kill. US Drug Enforcement Administration website. Available at: https://www.dea.gov/onepill. Accessed March 21, 2023.
- Drug Overdose Death Rates. National Institutes of Health/National Insitute on Drug Abuse website. Available at: https://nida.nih.gov/research-topics/trends-statistics/overdose-death-rates. Accessed April 17, 2023.
- If fentanyl is so deadly, why do drug dealers use it to lace illicit drugs? ABC News website. Available at: https://abcnews.go.com/Health/fentanyl-deadly-drug-dealers-lace-illicit-drugs/story?id=96827602. Accessed March 23, 2023.
- DEA Reports Widespread Threat of Fentanyl Mixed with Xylazine. US Drug Enforcement Administration website. Available at: https://www.dea.gov/alert/dea-reports-widespread-threat-fentanyl-mixed-xylazine. Accessed March 21, 2023.
- DEA issues alert about widespread threat of xylazine. CNN Health website. Available at: https://www.cnn.com/2023/03/20/health/dea-xylazine-warning/index.html. Accessed March 21, 2023.
- FDA alerts health care professionals of risks to patients exposed to xylazine in illicit drugs. US Food and Drug Administration website. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-risks-patients-exposed-xylazine-illicit-drugs. Accessed April 2, 2023.
- Warning Issued for Emerging Synthetic Opioid in Ohio. Dave Yost—Ohio Attorney General website. Available at: https://www.ohioattorneygeneral.gov/Media/News-Releases/April-2022/Warning-Issued-for-Emerging-Synthetic-Opioid-in-Oh. Accessed March 22, 2023.
- Five Quick Facts: Carfentanil. Get the Facts About Drugs/Just Think Twice website. Available at: https://www.justthinktwice.gov/article/five-quick-facts-carfentanil. Accessed April 17, 2023.
- First Responders Prepare for Possible Surge in Deadly Carfentanil Use in NH. News from New Hampshire and NPR website. Available at: https://www.nhpr.org/health/2017-04-27/first-responders-prepare-for-possible-surge-in-deadly-carfentanil-use-in-n-h#stream. Accessed April 17, 2023.
- Understanding Fatal Overdoses to Inform Product Development & Public Health Interventions to Manage Overdose (slide presentation). Reagan-Udall Foundation for the FDA. Available at: https://reaganudall.org/sites/default/files/2023-03/Understanding%20Fatal%20Overdoses_Slides_Day%201.pdf. Accessed April 17, 2023.
- Millennium Health Signals Report™. Fentanyl in Focus. Perspectives on Polysubstance Use in 2022. Volume 5. Available at: https://www.millenniumhealth.com/signalsreport/. Accessed April 17, 2023.
- Alabama medical experts issue fentanyl warning: Do not take any drugs not prescribed by a medical professional. Alabama.com website. Available at: https://www.al.com/news/2022/10/alabama-medical-experts-issue-fentanyl-warning-do-not-take-any-drugs-not-prescribed-by-a-medical-professional.html. Accessed March 22, 2023.
- Somerville NJ et al. Characteristics of Fentanyl Overdose—Massachusetts, 2014-2016. MMWR. 2017;66(14):382-386.
- US Department of Health and Human Services (HHS), Office of the Surgeon General, Facing Addiction in America: The Surgeon General’s Report on Alcohol, Drugs, and Health. Washington, DC: HHS, November 2016.
- Fentanyl Overdose. Addiction Info for Rehab and Recovery website. Available at: https://addictioninfo.org/fentanyl-overdose/. Accessed March 23, 2023.
- Opioid Overdose. Substance Abuse and Mental Health Services Administration website. Available at: https://www.samhsa.gov/medications-substance-use-disorders/medications-counseling-related-conditions/opioid-overdose. Accessed March 24, 2023.
- Abdelal R, Banerjee AR, et al. Real-world study of multiple naloxone administration for opioid overdose reversal among bystanders. Harm Reduct J. 2022;19(49). https://doi.org/10.1186/s12954-022-00627-3
- Zibbell J, et al. Non-Fatal Opioid Overdose and Associated Health Outcomes: Final Summary Report. US Department of Health and Human Services. Available at: https://aspe.hhs.gov/sites/default/files/migrated_legacy_files//190846/Nonfatal.pdf. Accessed April 2, 2023.
- Mell HK, et al. Emergency Medical Response Services Response Times in Rural, Suburban, and Urban Areas. JAMA Surg. 2017;152(10):983-984.
- Narcan® (naloxone HCl) Nasal Spray [prescribing information]. Plymouth Meeting, PA: Emergent Devices Inc., 2020.
- Access to Naloxone Can Save a Life During an Opioid Overdose. US Food and Drug Administration website. Available at: https://www.fda.gov/consumers/consumer-updates/access-naloxone-can-save-life-during-opioid-overdose. Accessed March 24, 2023.