How Ketamine and Ketamine for Children’s Health Works
The ketamine and ketamine hydrochloride capsules are designed to be taken once a day, and will be dispensed by pharmacies as a generic prescription drug for people over the age of 65, according to a press release from the Centers for Medicare and Medicaid Services.
The products, which will be sold as a two-pack of 10 capsules each, are intended for children who have a history of seizures and have been prescribed ketamine, the agency said.
The Ketamine Drug Evaluation and Research (KDAIR) program will help determine whether children’s use of the ketamine capsules are safe.
Children’s health centers will also be able to administer the ketamines to children under 18 years old.
The Ketamine Safety and Monitoring System (KSMMS) will be used to monitor ketamine’s safety and to determine if the product is being used safely, the release said.
“With this new system, we are able to take the most effective, effective, proven treatment option available to children,” Dr. John Bouchard, chief medical officer of the KSMMS, said in a statement.
The FDA is considering allowing the drug to be sold under a generic name to help address concerns about the drug’s safety.
The agency said it will evaluate other options for children’s safety, including a more comprehensive review of the risks and benefits of the drug and its products.