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FDA Approves Liquid Cannabinoid Product
The FDA has approved an orally administered liquid formulation of the cannabinoid drug dronabinol (Syndros, Insys Therapeutics), a pharmaceutical version of tetrahydrocannabinol (THC). Liquid dronabinol is indicated for use in treating anorexia associated with weight loss in patients with acquired immune deficiency syndrome (AIDS), and in treating nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. The product is currently awaiting scheduling by the Drug Enforcement Administration.
Dronabinol may cause psychiatric and cognitive effects and may impair mental and/or physical abilities. Patients with cardiac disorders may experience hypotension, hypertension, syncope, or tachycardia. Products containing disulfiram or metronidazole should be discontinued at least 14 days before treatment with liquid dronabinol and should not be administered within seven days after treatment.
Clinicians should weigh the potential risks versus benefits before prescribing liquid dronabinol to patients with a history of seizures, including those requiring antiepileptic medications or with other factors that lower the seizure threshold. In addition, clinicians should assess the risk for abuse or misuse in patients with a history of substance abuse or dependence before prescribing liquid dronabinol and should monitor patients for the development of associated behaviors or conditions. Clinicians should also consider dose reductions or discontinuation if symptoms of paradoxical nausea, vomiting, or abdominal pain worsen during treatment.
Source: Insys Therapeutics; July 5, 2016.