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  1. Safety & Availability (Biologics)

Important Information for Blood Establishments Regarding Brodifacoum Contamination of Synthetic Cannabinoids

June 29, 2018

Important Information for Blood Establishments Regarding Brodifacoum Contamination of Synthetic Cannabinoids

The Food and Drug Administration (FDA) has recently received several reports of Source Plasma donors who used synthetic cannabinoids contaminated with brodifacoum, which is an anticoagulant commonly used as a rodenticide.  Source Plasma is used for further manufacturing into plasma-derived products, and it is not directly transfused into individual patients.

To date, FDA has not received any reports of brodifacoum contamination of blood components intended for transfusion.  Individuals who have used synthetic cannabinoids (e.g. “fake weed”, “spice”, “K2”) contaminated with brodifacoum can experience severe abnormalities in coagulation because of the long-acting vitamin K antagonist activity of brodifacoum.  Consequently, potential safety concerns exist for both the blood donor and the donated blood components.  FDA is providing the following information and considerations in response to questions from blood and Source Plasma establishments on this new information.

Donor Eligibility

To be eligible for donation, all blood donors must be in good health and are subject to the donor eligibility requirements set forth in FDA regulations (21 CFR 630.10 and 630.15).  A potential donor is not eligible if a blood establishment identifies any factor that may cause the donation to adversely affect the health of the donor or the safety of the blood component (21 CFR 630.10 (a)). The blood establishment’s responsible physician should decide how to address a donor who presents with a history of synthetic cannabinoid use, and whether to screen all donors for a history of synthetic cannabinoid use based on the ongoing risks in their respective regions.

FDA is aware that some blood establishments have implemented donor education and donor deferral strategies to address the potential risks of brodifacoum contamination.  These strategies include displaying posters and distributing flyers to inform donors of the dangers of synthetic cannabinoids.  In some establishments, donors have been asked to acknowledge their reading of the newly provided information and report if the information pertains to them.  Some blood establishments have elected to add questions to the donor history questionnaire and institute deferral periods of up to one year following use of synthetic cannabinoids.

If a donor voluntarily reports use of synthetic cannabinoids, the blood establishment may wish to consider counseling the donor on the health consequences of brodifacoum contamination and the importance of seeking appropriate medical care.

Product Disposition

Blood components intended for transfusion or further manufacture may carry a risk if collected from a donor exposed to brodifacoum.  These risks, if any, remain uncertain.  Therefore, blood establishments that receive post-donation information that a donor has used synthetic cannabinoids may wish to consider whether to quarantine undistributed, in-date blood components that have not been pooled for manufacture dating back six months, and whether to notify consignees to quarantine such components so they will not be transfused or used for further manufacture.

With respect to plasma that has already been pooled for further manufacture or plasma derivatives manufactured from such donations, typical manufacturing protocols for plasma derivative products include pooling plasma from large numbers of donors.  The pooling would result in dilution of potential brodifacoum contamination.

Additional Information

Blood establishments may wish to consider communicating with their respective Departments of Health concerning brodifacoum contamination.  To date, most cases of brodifacoum contamination of synthetic cannabinoids have occurred in the Midwest region.  For further information on the topic and the latest updates, blood establishments can visit the Centers for Disease Control and Prevention website or contact their local Department of Health.

 

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