FDA is also requiring the addition of safety information about the risks of misuse, abuse, addiction, overdose, death, and slowed or hard breathing to the Boxed Warning, the most prominent warning, of the drug labels for prescription cough and cold medicines containing codeine or hydrocodone.
The Food and Drug Administration released a statement Thursday saying it will require changes to safety labels on prescription opioid cough and cold medicines that contain codeine or hydrocodone, citing the "serious risks" these medicines pose to children. Experts and pediatricians advised that while coughs in those under 18 sometimes do require treatment, usually the coughs were caused by a cold or upper respiratory infection; the risks of the opioid medication would outweigh benefits.
In September, the FDA met with the Pediatric Advisory Committee to determine the dangers associated with using opioids in children's cough medicine. Both of these determined the risks of slowed or hard breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18.
"Given the epidemic of opioid addiction, we're concerned about unnecessary exposure to opioids, especially in young children", said Scott Gottlieb, MD, FDA commissioner.
"It's critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone".
It is important for parents and caregivers to understand that a cough due to a common cold often does not need medicines for treatment. Labeling changes also address safety information for adults, including an expanded boxed warning indicating the risks of using opioid medications, such as misuse, abuse, addiction, overdose, and death.
In 2015, the FDA also announced an investigation into the possible risks of using codeine-containing medicines to treat coughs and colds in children under 18. Past year the restrictions were expanded to include safety labels that carried the contraindication warning, the FDA's most severe warning, to say that it should not be used for patients under the age of 12.
Parents whose children are now prescribed cold or cough medication containing codeine or hydrocodone are encouraged to talk with their doctors about other treatment options. Always read the labels on prescription bottles.
Some codeine cough medicines are available OTC in a few states, and FDA is also considering regulatory action for these products.
With the Falcons defense playing its best football, Foles and the Eagles will have their hands full in the Divisonal Round. Blake Bortles was a disaster, completing 12-of-23 passes for 87 yards while also adding 10 rushes for 88 additional yards.
The cabinet chaired by Prime Minister Narendra Modi gave its nod to several amendments in the FDI policy, including foreign investments in Air India under the approval route, which is subject to certain conditions.
Meanwhile, Lewis said he anticipates parliamentary maneuvers that would leave the work session running for the immediate future. During a House Democrats news conference, some lawmakers said they hoped address Medicaid expansion while they are in session.
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The stock is now moving below its 20-Day Simple Moving Average of -45.66% with a 50-Day Simple Moving Average of -47.1 percent. According to their observations and findings, the stock could provide a high EPS of $-0.2/share and a low EPS of $-0.21/share.
However, he is now a game-time decision Saturday as the Celtics visit the Brooklyn Nets on the second night of a back-to-back. Celtics: Aren't home again until January 16, a stretch that includes a game in London against Philadelphia on January 11.
Cedric Richmond (D-La.), claimed the president's comments are "further proof that his Make America Great Again agenda is really a Make America White Again agenda." Sen. "I thought about my own family".
After $0.35 actual earnings per share reported by KeyCorp for the previous quarter, Wall Street now forecasts 2.86% EPS growth. Stifel Financial Corporation owns 4.25 million shares. (NYSE:APD) has "Neutral" rating given on Friday, July 29 by Citigroup.
Simpson said he was dubious about Steele's plan to tell the Federal Bureau of Investigation it was a national security issue. The testimony contained numerous revelations about Fusion GPS , its work and its investigation into Trump.
The weather forecaster estimates an 82 percent chance of snow, according to a forecast provided through The Associated Press. Temperatures begin quite mild, in the middle 50s to near 60 degrees! Sunday will be mostly sunny with a high of 28 degrees.
Austin Aries came face to face with Global Champion Eli Drake and has completely flipped IMPACT upside down. Impact says the match and moment will be seen in the coming weeks.
Will Ferrell to host 'SNL' on January 27
Seven days after that, Chris Stapleton will accompany Ferrell on the former " SNL " standout's fourth turn as host . The " Daddy's Home 2 " star was a member of the " Saturday Night Live " cast from 1995-2002.
Monster Beverage Cp (MNST): Monitoring the Technicals
Whereas the traders who further want to see about this, may be interested to see Price to next year's EPS that would be 15.29%. Skylands Capital LLC acquired a new stake in shares of Monster Beverage in the third quarter valued at about $276,000.
Cowen Reaffirms Buy Rating for Pepsico (PEP)
The firm earned "Buy" rating on Monday, October 9 by Wells Fargo. (NASDAQ:PEP) on Friday, April 28 with "Buy" rating. It also upped Capital One Financial Corporation (NYSE:COF) stake by 247,645 shares and now owns 4.22M shares.
Detective Pikachu amiibo and game announced for North America
Another reward for patient fans will be the absurdly large special edition Detective Pikachu amiibo coming out alongside the game. It was announced today that Detective Pikachu will be released as a Nintendo 3DS exclusive in the USA and Europe on March 23.
Walmart abruptly closing 63 Sam's Club stores
"Our goal is to place as numerous impacted associates as possible at other Sam's Clubs or Walmart stores", he said in an email . Meanwhile, stores like Sam's Club, which lacks a clear specialty and faces stiff competition with Costco , have not done well.