Prescription opioid cough and cold medicines that contain codeine or hydrocodone are being stripped of their indications to treat cough in kids, FDA announced Thursday (Jan. 11).
Furthermore, labeling for these products will now include an expanded Boxed Warning, explaining "the risks of misuse, abuse, addiction, overdose and death, and slowed or hard breathing" that can result - even in adults.
The new requirements build on previous restrictions enacted by the agency last year, when the FDA required the addition of a contraindication warning to the labeling, to warn against use in children younger than 12 years old due to risk of ultra-rapid metabolism in certain patients.
"We know that any exposure to opioid drugs can lead to future addiction", Gottlieb said.
The agency said it is requiring manufacturers to change the wording on their labels to make clear that such products should not be used for anyone younger than 18. While today's action was meant to address prescription opioid cough/cold medications, the FDA is considering regulatory action for these OTC products as well.
Steep slopes on Mars reveal structure of buried ice
Colin Dundas, research geologist who led the study said "it was surprising to find ice exposed at the surface at these places". Radio scans by MRO suggest existence of thick, buried ice along the planet's middle latitudes.
Inc. Cuts Position in Golar LNG Partners LP (GMLP)
On a one to five ratings scale where 1.0 indicates a Strong Buy, 2.0 indicates a Buy, 3.0 a Hold, 4.0 a Sell and 5.0 a Stong Sell. Oceanic Investment Management Ltd decreased Golar Lng Ltd Bermuda ( GLNG ) stake by 15.36% reported in 2017Q3 SEC filing.
The agency urged parents to read the labels on prescription bottles. The administration advises parents children prescribed codeine or hydrocodone to talk their health care professional about alternate treatment options.
In any case, there's little that can or should be done to ease most children's cough and colds, the FDA said. The FDA held a risk-association discussion with its Pediatric Advisory Committee, during which experts indicated that cough due to colds or upper respiratory infections generally did not require treatment, and that the risks of prescription opioid cough therapy use did not outweigh its potential benefits. Common side effects of opioids include headache, dizziness and vomiting.
One physician who's dealt with the aftermath of opioid overuse applauded the move.
The FDA will also carry bigger warning about their dangers to adults, NBC News reported.
So what's the advice for parents who may be using these medicines for their child already?
The Goodyear Tire & Rubber Company (GT) has 0 billion shares outstanding now , 96.24% of which belong to institutional investors. TIAA CREF Investment Management LLC boosted its stake in The Goodyear Tire & Rubber Company by 29.0% in the third quarter.
She says that young immigrants shouldn't be shielded from deportation unless Democrats agree to build Trump's massive border wall. Martha McSally , R-Ariz., waves from a T-6 World War II airplane Friday as she leaves for Phoenix in Tucson, Ariz.
With the filings, Cohen becomes the closest person to the President to take on the dossier's explosive claims in court. FBI CANNOT (after all of this time ) VERIFY CLAIMS IN DOSSIER OF RUSSIA/TRUMP COLLUSION.
The Georgia-based Vident Inv Advisory Limited Liability Company has invested 0.02% in Progress Software Corporation (NASDAQ:PRGS). The average Wall Street analyst rating for Progress Software Corporation is Hold, according to the average of 3 analyst scores.
His star burgeoned in the early parts of the 2011 season, when he rushed for 818 yards and 10 touchdowns in seven games. According to Lou Bezjak of The State , Lattimore will be the director of player development on Will Muschamp's staff.
Truepoint Inc decreased its stake in Cintas Corp (CTAS) by 83.95% based on its latest 2017Q3 regulatory filing with the SEC. It dropped, as 37 investors sold CTAS shares while 174 reduced holdings. 18 funds opened positions while 56 raised stakes.
The current run-up of bitcoin may be a bubble, but beneath that bubble is a major technological breakthrough. Monero and Ripple arguably represent the two extremes of the ideological spectrum of cryptocurrencies.
The loss marks the first time Tennessee has dropped a game since being eliminated from last year's NCAA tournament on March 20. Tennessee wasn't as effective in turning points into turnovers - 15 points from turnovers, compared to Texas A&M's 18.
Kasur made worldwide headlines in 2015 when a gang of paedophiles running a child sex ring was busted, Dawn reported. Police authorities have been given the report of the DNA test in the girl's case, the source said.
ValuEngine lowered Entercom Communications from a "buy" rating to a "hold" rating in a research note on Sunday, December 31st. BMO Capital Markets upgraded Premier Oil plc (LON:PMO) on Tuesday, February 2 to "Market Perform" rating.
Rational Advisors LLC purchased a new stake in shares of Lennar during the third quarter valued at approximately $1,438,000. It fall, as 25 investors sold CFX shares while 71 reduced holdings. 115 funds opened positions while 470 raised stakes.
Q's Abdul Qudoos Bizenjo elected as Balochistan CM
A total 54 votes were polled by the lawmakers and Pashtunkhwa Milli Awami Party's (PkMAP) Agha Syed Liaquat Ali bagged 13 votes. Bizenjo belongs to the troubled Awaran district of Balochistan and was elected on a PML-Q ticket during general elections 2013.
Acre Thomas Fire in Southern California Now 100% Contained
Federal and state authorities are now examining the burn area to assess the risks for flooding and other post-fire hazards. In the wake of this week's strong winter storm, the 281,893-acre Thomas Fire was declared fully contained on Friday.