Regulatory Updates: Warnings Regarding Synthetic Marijuana Use by Plasma and Blood Donors

AABB issued an update in 2018 to inform blood collection facilities of recent warnings regarding serious health events related to synthetic marijuana use based on information from state health departments and the Food and Drug Administration (FDA). Officials from FDA’s Center for Biologics Evaluation and Research (CBER) are aware of cases of severe bleeding in individuals who have recently used synthetic cannabinoids contaminated with brodifacoum, a lethal anticoagulant commonly used as a rodenticide. CBER is in communication with the Centers for Disease Control and Prevention (CDC). AABB’s Donor History Task Force and the Blood Bank and Transfusion Standards Committee are also reviewing the early information related to this issue. The CDC website offers general information “About synthetic cannabinoids.” AABB will provide an update as soon as additional information becomes available. The following summarizes AABB’s current understanding of the risks and concerns.

The Indiana State Department of Health (ISDH) has stated that “As of April 5, Illinois public health officials have identified 89 cases of vitamin K dependent coagulopathies (bleeding) associated with synthetic marijuana use. The Indiana Health Alert Network Advisory attributes two deaths to the effects of synthetic marijuana, commonly known as fake pot, fake weed, legal weed, spice, K2, KD, Mind Trip, OMG, Black Giant, Matrix, Scooby Snacks, AK-47, Genie, Sexy Monkey.” Based on this potential life-threatening coagulopathy, the ISDH Advisory provides recommendations regarding blood and plasma donor screening and eligibility. The ISDH also offers additional information on Synthetic Cannabinoids/Spice, including an educational flyer recommending against plasma and blood donation.

Likewise, the Illinois Department of Public Health (IDPH) has been investigating an outbreak of severe bleeding in Chicago, multiple Chicago-area counties, and Central Illinois that has resulted in multiple deaths. IDPH has notified the FDA of three plasma donations made at plasma centers in Illinois. These early cases tested positive for the “rat poison” brodifacoum. The IDPH is encouraging “blood and plasma centers to be vigilant in their screening of potential donors.” An IDPH call to action infographic and links to numerous resources can be found on the IDPH website. 

An early report stated that to date “…it is not clear whether or to what extent there is a risk of transmission of such anticoagulants from potentially contaminated products…Individuals who have used synthetic cannabinoids and been exposed to long-acting anti-coagulants are at risk of severe continued bleeding, including from venipuncture. As this population appears to donate plasma frequently, we recommend thorough screening to reduce the risk of this bleeding, and provide appropriate medical evaluation if such event occurs.” It has been estimated that brodifacoum will stay within the systemic circulation for at least 4 months based on a terminal half-life of approximately 24 days.

At this time, FDA advises both licensed and unlicensed blood establishments to contact their Consumer Safety Officer at CBER with questions on donor screening and product management. At any time, a Medical Director of a blood collection facility may determine that it is necessary to implement more restrictive deferral policies than are required by AABB and FDA, based on local or regional concerns. The Medical Director may use a poster at collection sites to inform the donors (similar to the IDPH infographic or the ISDH flyer), include relevant information in the donor educational material and/or adding a screening question to the current Donor History Questionnaire (DHQ). AABB encourages members to refer to the DHQ User Brochure (found on the AABB DHQ page) for more information on acceptable changes. Blood collection centers electing to screen blood donors for the use of synthetic cannabinoids, based on local or regional concerns, are permitted to add a question(s) to the area for additional questions at the end of the AABB Donor History Questionnaire.