Although nearly 70% of the population cohort had conditions requiring medications, there was no increase in the number of reported adverse events while taking CBD products.
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Results of a recent study from Validcare investigating the safety of hemp-derived cannabidiol (CBD) products reported no evidence of liver disease and no increase in the prevalence of elevated liver function tests when compared with a population with analogous rates of medical conditions, according to a news release.
The 7-month long clinical investigation of 839 participants was designed to address the FDA’s requests for science-based data on CBD use so that the agency can effectively determine safety and proper regulatory pathways for hemp-derived CBD products.
Related: FDA Sends 2 More Warning Letters to Companies Selling OTC CBD Products
The FDA has been cracking down on companies purporting unfounded health claims for CBD products and has affirmed its interest in “exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety,” Amy Abernethy, MD, PhD, FDA principal deputy commissioner, said in a recent news release.
As such, the Validcare study offers clinical evidence depicting the safety of hemp-derived CBD products in regard to liver function and adds to the growing compendium of data depicting the potential benefits of CBD.
The study aimed to observe the prevalence of liver effects in adults taking orally administered hemp-derived CBD products for a minimum of 60 days.
“What we observed to date is no clinical evidence of liver disease in any participants,” said co-investigator and Drug Topics® Editorial Advisory Board member Jeff Lombardo, PharmD, BCOP. “We observed slight, clinically insignificant elevations of liver function tests in less than 10% of consumers irrespective of age, product composition and form and the amount consumed.”
Lombardo explained that 3 of the 839 participants showed levels of the liver enzyme alanine aminotransferase (ALT) that were 3 times higher than normal. “These 3 consumers are taking prescription medications that are known to elevate liver enzymes, and we are investigating whether prescribed medications or other factors contribute to these outliers,” he said.
Investigators reported that although nearly 70% of participants in the study had a health condition requiring medications, data showed no increase in the rate of adverse events (AEs). Additionally, similar study demographics have previously shown an 11% elevation in liver function tests; however, the Validcare study demonstrated an elevation of about 9%.
“We are encouraged by these findings and hopeful this study provides FDA with sufficient science-based data to determine and take action on a safe regulatory path forward,” said Keith Aqua, MD, co-principal investigator of the study.
The principal investigators met with the FDA on March 15 to review preliminary liver safety data and discuss establishing a direct communication feed to the agency in order to facilitate raw, blinded analyses.
Reference
- Validcare’s Clinical Study Reports Preliminary Results of CBD Liver Study. News Release. Validcare; March 23, 2021. Accessed March 31, 2021. https://validcare.com/press/validcares-clinical-study-reports-preliminary-results-of-cbd-liver-safety/.
Source: drugtopics.com
