The Day

FDA approves first marijuana-based drug for seizures

- By MATTHEW PERRONE AP Health Writer

British drugmaker GW Pharmaceut­icals studied the drug in more than 500 Washington — U.S. health regulators on children and adults with hard-to-treat Monday approved the first prescripti­on seizures, overcoming numerous legal hurdrug made from marijuana, a milestone dles that have long stymied research into that could spur more research into a drug cannabis. that remains illegal under federal law, deFDA officials said the drug reduced seispite growing legalizati­on for recreation­zures when combined with older epilepsy al and medical use. drugs. FDA chief Scott Gottlieb said his

The Food and Drug Administra­tion apagency had supported research on cannaprove­d the medication, called Epidiolex, bis-derived products “for many years.” to treat two rare forms of epilepsy in pa“This approval serves as a reminder tients 2 years and older. But it’s not quite that sound developmen­t programs that medical marijuana. properly evaluate active ingredient­s con

The strawberry-flavored syrup is a putained in marijuana can lead to important rified form of a chemical ingredient found medical therapies,” Gottlieb told reporters.inthecanna­bisplant—butnottheo­ne that gets users high. It’s not yet clear why The FDA has previously approved synthe ingredient, called cannabidio­l, or CBD, thetic versions of another cannabis ingrereduc­es seizures in some people with epdient for medical use, including severe ilepsy. weight loss in patients with HIV.

Epidiolex is essentiall­y a pharmaceut­ical-grade version CBD oil, which some parents already use to treat children with epilepsy. CBD is one of more than 100 chemicals found in marijuana. It doesn’t contain THC, the ingredient that gives marijuana its mind-altering effect.

Physicians say it’s important to have a consistent, government-regulated version.

“I’m really happy we have a product that will be much cleaner and one that I know what it is,” said Dr. Ellaine Wirrell, director of the Mayo Clinic’s program for childhood epilepsy. “In the artisanal products there’s often a huge variation in doses from bottle to bottle depending on where you get it.”

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

 ??  ??

Newspapers in English

Newspapers from United States