FDA OKs First Drug Containing CBD

Henrietta Brewer
June 26, 2018

The FDA paid attention, and Monday approved Epidiolex, the first-ever prescription drug derived from marijuana.

A mother feeds her epileptic son, whom she treats with medical marijuana, in Siedlce, Poland, in October 2017.

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The FDA still hasn't given its blanket approval to marijuana as a "safe and effective drug", though it has OK'd three medications that contain synthetic compounds similar to those found in the marijuana plant. But Garris highlighted that numerous side effects occur when it is taken with other medications, which she said is a concern because most patients are on other medications. The British drugmaker studied the drug in more than 500 patients with hard-to-treat seizures, overcoming numerous legal hurdles to conducting research with cannabis.

"It's also important to note that this is not an approval of marijuana or all of its components", said Dr. Scott Gottlieb, the FDA's commissioner. Cannabis-derived CBD products are available where recreational marijuana is sold, though CBD derived from industrial hemp faces fewer regulations and is even stocked by some grocery stores. Researchers and advocates cautioned against this, however, with the caveat that it's impossible to verify that what's in those products is actually pharmaceutical-grade CBD.

If the DEA reschedules cannabidiol, that would be the beginning of cannabis-derived compounds being recognized by top federal agencies as a legitimate medicine. It was low in THC, what gets you high, and it was hope for Zaki.

Side effects with the drug include diarrhea, vomiting, fatigue and sleep problems.

Several states have legalized CBD oil specifically for the treatment of intractable epilepsy or seizure disorders. At just 4 months old, he started having violent seizures.

The FDA previously cracked down on CBD companies for claiming their products could treat cancer and other conditions.

Epidiolex won't require a special certification to prescribe, Patel said, and it's likely physicians will prescribe it for off-label uses.

Why? Because their product and company status will no longer exist in the legal gray area, and hopefully the mass confusion over which CBD products are legal and which are not will come to an end. It comes from a proprietary strain of cannabis grown by GW that has been bred to have high levels of CBD and low levels of THC, the component that does make people high.

The immediate impact of Monday's approval on these products is unclear. Carreno says that once the drug is descheduled, CBD manufacturers must register with the DEA-and that will make all the difference to the industry in the U.S.

"Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug's uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes", Gottlieb said.

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