The agency has received reports of adverse events in patients using marijuana to treat medical conditions. The FDA is currently reviewing those reports and will continue to monitor adverse event reports for any safety signals attributable to marijuana and marijuana products, with a focus on serious adverse effects associated with the use of marijuana.
Information from adverse event reports regarding marijuana use is extremely limited; the FDA primarily receives adverse event reports for approved products. General information on the potential adverse effects of using marijuana and its constituents can come from clinical trials using marijuana that have been published, as well as from spontaneously reported adverse events sent to the FDA. Additional information about the safety and effectiveness of marijuana and its constituents is needed. Clinical trials of marijuana conducted under an IND application could collect this important information as a part of the drug development process.
