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.
Will Muschamp and his SC staff receive extensions, raises
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.
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?
Palace manager Roy Hodgson will hope to have both back for the trip to the Emirates Stadium to take on Arsenal next week. In better news, Christian Benteke and Wilfried Zaha could return to the setup for Saturday's encounter.
The polling stations will close at 22:00 on Friday night and the election will continue from 8:00 till 14:00 on Saturday. The topless protestor from Ukraine's Femen group was overpowered by bodyguards and then arrested by police.
Reports, however, say this ability to make Duo calls to even those who aren't using the app is now restricted to Android users. However, if the someone without Duo installed wants to make a call, then they'll have to install the app first.
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.
The stock of Plains All American Pipeline , L.P. (NYSE: PAA ) earned "Overweight" rating by Morgan Stanley on Tuesday, October 4. Global Endowment Management LP increased its holdings in Plains All American Pipeline by 40.7% in the 2nd quarter.
The Swiss government ordered a ban on the boiling of live lobsters as part of efforts to reform its animal welfare laws. He gave the crabs two different options for shelter: one that caused repeated shocks and another which didn't.
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.
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.
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.
This week at CES, Lenovo and JBL showed off new Assistant-powered smart displays built in collaboration with Google. There's no doubt Google's first crack at making an optical head-mounted display was ahead of its time.
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.