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The FDA has not approved ketamine products for the treatment of psychiatric disorders. The agency says there is increased risk in compounded ketamine.
The U.S. Food and Drug Administration issued a warning urging consumers and healthcare providers to be aware of the risks involved with using compounded ketamine products for the treatment of any psychiatric disorder.
The FDA says it has not approved the use of the drug for treating psychiatric disorders, but there have still been documented uses of compounded ketamine to treat disorders including depression, post-traumatic stress disorder, anxiety and obsessive-compulsive disorder.
The agency says compounded drugs can serve an important purpose in the practice of medicine for some patients when there are no FDA-approved drugs that are medically appropriate.
The FDA says there are known safety issues with the use of ketamine including the risk of abuse, misuse, increased blood pressure, psychiatric events, depression of the respiratory system and lower bladder and urinary tract symptoms.
The FDA has put Ketamine hydrochloride into the Schedule III controlled substance category, and approved it for intravenous or intramuscular injection as a general anesthesia.
But the FDA warned that"Patients who receive compounded ketamine products from compounders and telemedicine platforms for the treatment of psychiatric disorders may not receive important information about the potential risks associated with the product."
The FDA says that home use of ketamine products adds even more risk because the patient isn't being monitored by a health care provider. The agency says additional clinical studies are needed to look into the drug's benefit-risk profile.
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