Fentanyl

The U.S. Food and Drug Administration cleared the use of Alltest Fentanyl Urine Test Cassette, which is the first over-the-counter test for the preliminary detection of fentanyl in urine. The test works by placing three drops of fresh urine onto a cassette containing a fentanyl test strip. After 5 minutes the test result will appear as colored lines. Although the test does not distinguish between certain drugs and medications. 

The Reagan-Udall Foundation partnered with the Food and Drug Administration (FDA) for the "Mitigating Risks from Human Xylazine Exposure" virtual and in-person webinar that occurred early October 2023. This public meeting explored real-world experiences and scientific evidence on emerging data trends for human xylazine exposure and examined concrete strategies for drug development and clinical research that directly supports the mitigation and reduction of risks associated with human exposure to xylazine. The meeting materials, recordings, and slides are now available for viewing. 

The National Institute on Drug Abuse (NIDA) Center for the Clinical Trials Network (CCTN) held an event where health care professionals and federal partners discussed xylazine-related testing, treatment, and wound care. As the White House has deemed fentanyl adulterated with xylazine an emerging threat, it is important to identify and adapt to the rapidly changing practices of patient care.

This presentation provided an overview of the (1) current U.S. prevalence of opioid abuse and OUD and their societal consequences, (2) impacts of the opioid epidemic on rural geographic areas and populations, (3) recent emergence of synthetic opioids (e.g., fentanyl) and xylazine in the U.S. drug supply, and (4) most empirically supported treatment for patients with OUD.

The Office of National Drug Control Policy (ONDCP) released a plan in response to fentanyl being adulterated or associated with xylazine, which was declared as an emerging drug threat in April 2023. Due to the effect of combining these substances, people may be less responsive to naloxone in an overdose situation. The response plan includes evidence-based prevention, treatment, and supply reduction action steps, goals, and performance measures. 

The Centers for Disease Control and Prevention released data showing a significant increase – 276 percent in 21 jurisdictions from 2019 to 2022 – in overdose deaths involving Xylazine, a nonopioid sedative that’s been detected in illicitly manufactured fentanyl drug products. 

With the proliferation of fentanyl and other adulterants in the national illicit drug supply, people who use drugs (PWUD) are at greater risk of overdose. Among more than 107,000 drug overdose deaths that occurred between July 2021–June 2022, 64% involved synthetic opioids like fentanyl. Lowering the high rates of overdose among PWUD is possible, as evidence-based practices exist to prevent and respond to overdose, including fentanyl test strips and advanced drug checking equipment. To inform health departments’ harm reduction programming, the National Council for Mental Wellbeing – with support from the Centers for Disease Control and Prevention – developed Enhancing Harm Reduction Services in Health Departments: Fentanyl Test Strips and Other Drug Checking Equipment, an educational brief grounded by real-world experience. 

The first phase of the campaign created by the White House Office of National Drug Control Policy (ONDCP) and Ad Council was launched to education young people on the dangers of fentanyl and the life-saving effects of Naloxone, a medicine that reverses opioid-related overdoses. This campaign expands on the Ad Council's The Real Deal on Fentanyl platform.

The Reagan-Udall Foundation for the FDA (FDA Foundation), in partnership with several operating divisions within the Department of Health and Human Services (HHS), convened two roundtable meetings to understand the perspectives of the harm reduction community, clinicians, and researchers about using fentanyl drug checking and screening as harm reduction and clinical strategies.