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THE RIGHT TREATMENT | FOR THE RIGHT PATIENT | AT THE RIGHT TIME | EVERY TIME
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New CDER Research on the Effect of Cannabidiol on Liver Enzymes and Endocrine Measures Highlighted in CDER Impact Story |
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Despite limited and inconsistent human safety data, unregulated cannabidiol (CBD) products are widely available to consumers. In this CDER Impact Story, CDER experts describe a randomized, double-blinded, placebo-controlled study demonstrating that CBD use at doses representative of consumer products is associated with liver enzyme elevations in 5.6% of healthy adults. The study findings have important regulatory implications that can inform discussions about appropriate safeguards and underscore the need for further investigation of the long-term effects of CBD use, its effects on various populations, and the safety of lower doses commonly used by consumers.
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The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today or click the button below and select Clinical Pharmacology Corner under Drugs.
We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov.
This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.
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