CDC: Antibiotic-resistant salmonella outbreak includes Kentucky
Arizona health officials confirm 2 cases of rare illness paralyzing kids
October is optimal time to get a flu shot, experts say
127 suspected and confirmed cases of polio-like condition — CDC
US Health Officials Puzzled by Mystery Paralysis Spreading in Children
FDA Approves The First Marijuana-Derived Drug For Childhood Epilepsy
26 June 2018, 03:27 | Randall Craig
FDA approves first cannabis-based drug
Today's approval of Epidiolex is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies.
US health regulators have approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law.
Two months after a unanimous recommendation by an outside group of FDA experts and some glowing recommendations in the internal review, GW will now set out to open up a new class of meds after demonstrating the drug's ability to prevent seizures in children suffering from rare cases of Lennox-Gastaut syndrome and Dravet syndrome.
Patients with Lennox-Gastaut and Dravet syndromes, which typically emerge in the first few years of life, can suffer from debilitating and recurrent seizures, sometimes dozens a day.
GW Pharma grows its own supply of cannabis in specialized glass houses in the United Kingdom to ensure uniformity in the genetic composition of the plants, which are then processed into a liquid solution of CBD.
In 1985, the FDA signed off on Marinol, which contains a synthetic version of THC, to treat loss of appetite in people with AIDS. "And the FDA is committed to this kind of careful scientific research and drug development", Gottlieb concluded.
In company-sponsored clinical studies, cannabidiol reduced the frequency of patients' seizures.
"For those living with intractable seizures caused by LGS and Dravet syndrome, Epidiolex represents a true medical advancement", said Philip Gattone, president and CEO of the Epilepsy Foundation.
"These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician's care", Gover said.
Epidiolex would also be the first approved therapy for DS, treatments for which are now limited to a combination of seizure medication and drugs to prevent emergencies.
Side effects with the drug include diarrhea, vomiting, fatigue and sleep problems.
"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies" said FDA Commissioner Scott Gottlieb. "There's no time line or clock that starts ticking on us". Until now, the Drug Enforcement Administration has classified CBD as a Schedule 1 substance.
Shauna Garris, a pharmacist, pharmacy clinical specialist and adjunct assistant professor at the University of North Carolina's Eshelman School of Pharmacy, said the drug is effective and works somewhere between "fairly" and "very well". A study at the end of previous year found that almost 70 percent of CBD products sold online were mislabeled.
Kushner: US to Unveil Middle East Peace Plan Soon
He noted that his wife, Catherine, spent nearly three years in Jordan as a child when her father worked there for British Airways. During their first stop, the pair visited a technology lab for digital manufacturing, supported by the Crown Prince Foundation.
Neymar sheds 'tears of joy' after defeating Costa Rica
Neymar will play in Brazil's vital World Cup match against Costa Rica on Friday despite injury fears, coach Tite has confirmed. Just like in Brazil's first game against Switzerland, Neymar could be found on the floor more often than not.
Spain vs. Morocco - Football Match Report
Morocco knew they were out of the tournament but took the game by the scruff of the neck as the match was evenly contested. Spain rode their luck at times on Monday as they scraped the draw which was enough to see them finish as group winners.
Prince William arrives in Israel as part of regional tour
The visit comes just after Israel marked its 70th anniversary of independence and amid surges of violence along the Gaza border. He will stay with his entourage, including Foreign Office officials, at the five-star King David Hotel in Jerusalem .
Mats Hummels fit to face South Korea in World Cup decider
Hummels missed Saturday's dramatic 2-1 win over Sweden through injury, but was able to return to training on Monday. We had just let in a goal and lost the game, so it was pretty sour. "We stand united, we are Sweden", he added.
Harley-Davidson to make more motorcycles outside the US
Companies that make raw materials benefit, while those that turn those raw materials into more advanced products will be hurt. Europe is Harley's second biggest market outside the US and sold nearly 40-thousand motorcycles in the Europe a year ago .