FDA Changes Safety Label for Pediatric Prescription Opioid Medication

FDA Changes Safety Label for Pediatric Prescription Opioid Medication

The US Food and Drug Administration (FDA) on Thursday announced safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone as the risks of these medicines outweigh their benefits in children younger than 18.

Additionally, labels will also include updated safety information for use in adults, including an expanded boxed warning notifying about the risks of misuse, abuse, addiction, overdose, death, and slow or hard breathing that can result from exposure.

The FDA said it conducted extensive reviews of available data and sought expert advice on opioid use in the treatment of childhood pain and cough.

The FDA pointed to known side effects of opioid medications, including "drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache".

Karnataka CM Siddaramaiah meets Congress chief Rahul Gandhi in Delhi
Karnataka will go to polls later this year with the tenure of the current state assembly ending in May. He said the Congress would win a comfortable majority in the assembly polls due in a few months.

"It's critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone", he added.

The new warnings are consistent with the labels on other drug products with opioids, including painkillers. 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.

The FDA will remind parents that most coughs and colds don't need any treatment at all.

The FDA says treating sick children with medicines that contain opioids poses "serious risks that don't justify their use".

Five People Missing After California Mudslides; Thomas Fire Finally Out
The death toll went up to 18 Friday afternoon, and the number of missing people in Santa Barbara County was lowered to five. It wasn't fully contained until this week . "We were all bad children and ignored the warning", he said.

One physician who's dealt with the aftermath of opioid overuse applauded the move.

It's always important to read medicine labeling, too - even if it's not obtained by prescription.

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.

Robert Whittaker out of UFC 221 title fight with Luke Rockhold
A former Cuban Olympic silver-medalist wrestler, Romero was scheduled to face Branch at a UFC Fight Night event on February 24. Because of the change in main event, fans will be able to request full refunds of purchased tickets for UFC 221.

Related News:

  • Michigan State Spartans vs. Michigan Wolverines: Preview and Prediction

    Michigan State Spartans vs. Michigan Wolverines: Preview and Prediction

    He wants to make sure Michigan limits Michigan State on the offensive glass, particularly sophomore center Nick Ward . Throw in the seven-game win streak prior to that game, and John Beilein's squad should be brimming with confidence.
    Dark Souls Trilogy Box Set Coming To PlayStation 4 in May

    Dark Souls Trilogy Box Set Coming To PlayStation 4 in May

    Previously, all games of the " Souls " sub-genre of roleplaying games (RPGs) were only released on the PlayStation, Xbox, or PC. According to a recent report, Bandai Namco has plans to bring both Dark Souls II and Dark Souls III to Nintendo Switch .
    Legendary broadcaster Keith Jackson dies at age 89

    Legendary broadcaster Keith Jackson dies at age 89

    The announcer left an imprint on the game few can approach, with Jackson's presence immediately elevating the action on the field. Keith Jackson was the voice of college football . "This is the flawless time", Jackson told The New York Times in May 2006.
  • Trump Says Won't Sign Immigration Bill Without Funding for Border Wall

    Trump Says Won't Sign Immigration Bill Without Funding for Border Wall

    The White House had argued that DACA was an "unconstitutional exercise of authority" by the Obama administration. While this case plays out in the courts, there's another debate over DACA happening on Capitol Hill.

    Cuba condemns Trump's "racist" statements on Haiti, El Salvador

    Trump has inaccurately claimed that Barack Obama, the nation's first black president , wasn't born in the United States. In Senegal's capital Dakar, administrator Idrissa Fall said "we can not really say that he (Trump) is wrong".
    The Handmaid's Tale: Here's your haunting first look at season 2

    The Handmaid's Tale: Here's your haunting first look at season 2

    Miller confirmed that he an Atwood began discussing the shape of season two halfway through season one. Sometimes while writing the scripts, I just really wanted to surprise her, ' he said.
  • Paisley leads South African Open, Grace chasing hard

    Paisley leads South African Open, Grace chasing hard

    This is his second tournament of the 2018 European tour season. "I'm just really excited about it". Austin Connelly made the cut at the BMW SA Open golf championship in Edenvale, South Africa.
    Kids are overusing iPhones, warn two Apple investors

    Kids are overusing iPhones, warn two Apple investors

    The letter cites a collection of studies that show that as little as 3 hours spent on smartphones every day can harm children's physical and mental well-being.
    Carrie Underwood Joins With Ludacris for 'The Champion'

    Carrie Underwood Joins With Ludacris for 'The Champion'

    Now that Super Bowl LII is approaching soon, Carrie Underwood has released the annual championship's anthem entitled " The Champion " featuring Ludacris .
  • A Glimpse Into Insider Trading And Ownership At Schlumberger Limited (SLB)

    The stock of Schlumberger Limited (NYSE: SLB ) earned "Market Perform" rating by BMO Capital Markets on Wednesday, October 11. The total amount of shares outstanding is 1.39 billion, giving the company a market capitalization of about 103.74 billion.

    Marathon Petroleum (MPC) Getting Somewhat Positive Media Coverage, Analysis Shows

    Forbes J M & Co Llp decreased its stake in Tjx Cos Inc (TJX) by 93.67% based on its latest 2017Q3 regulatory filing with the SEC. Edward Jones upgraded Marathon Petroleum from a "hold" rating to a "buy" rating in a research note on Friday, October 6th.
    Eastward-looking Zeman is favourite as Czechs vote for president

    Eastward-looking Zeman is favourite as Czechs vote for president

    Among the leading candidates, Zeman has been the most outspoken on migration, linking Muslim immigration to security threats. CSU will release the results on its website, and the final results are to be available on Saturday evening.


Most liked

Tottenham vs Everton - Betting Tips and Predictions
Everton have gone nine league and cup games without a win away to Spurs since November 2008, drawing three times and losing six. Pochettino said he was not anxious by the club's potential inactivity, however, adding: "I am confident always".

Cops on standby as EFF goes on H&M rampage
The campaign group Models Of Diversity, which pushes for more diversification across the industry, said H&M should be "ashamed". Though the child's mother did not see a problem with it, the popular clothing chain apologized for the image.

Modest Leganes face Real Madrid in Copa del Rey
Messi then turned provider, lobbing a ideal pass behind Celta's back line to meet the run by Alba, who chipped Alvarez to score. With new signing Philippe Coutinho watching on from the stands, Lionel Messi led the destruction of the Galician side.

Wal-Mart Stores, Inc. (WMT) Shares Bought by Advisor Group Inc
The stock was sold at an average price of $99.29, for a total value of $119,148.00. $37.94M worth of Wal-Mart Stores, Inc. This buyback authorization authorizes the retailer to repurchase shares of its stock through open market purchases.

Micron Technology, Inc. (NASDAQ:MU) Director Sells 3000 Shares of Stock
Currently, the stock carries a price to earnings ratio of 0, a price to book ratio of 8.99, and a price to sales ratio of 4.55. With 1.08 million avg volume, 6 days are for Godaddy Incorporated (NYSE:GDDY)'s short sellers to cover GDDY's short positions.

10 moments from the Golden Globes that made the internet freak out
The Oscar-winning actress stars as a grieving mother who challenges police over the fact her daughter's killer has not been found. For those who didn't see the film , that success might leave some pop culture and movie fans a bit curious.

National Championship thriller scores big ratings for ESPN
Alabama 24, Georgia 14: Remind me never again to doubt Alabama , which proves its point that it is still tops in the nation. Smart, who spent 11 seasons with Saban - eight as defensive coordinator in Tuscaloosa - quickly built 'Bama East.

Dark Souls Announces Remastered Edition, Also Being Released On Nintendo Switch
Additionally, it will have soundtracks for each of the games, knight and bonfire bookends, an encyclopedia, and a special art set. Hidden in the world of DARK SOULS: REMASTERED are nine online covenants to uncover that will motivate your online interactions.

Espanyol boss Flores rules himself out of Stoke running
I'm well, absolutely content with my situation, and I don't have to explain anything else". "We feel happy. He said: "I'm not going to talk about me on such an important day for Espanyol ".

CVS: No Plans To Move Aetna From Hartford
He said he would advocate for Hartford with CVS Health leaders "to build a strong working partnership". The city of Hartford is in its own financial straits, relying on state aid to balance its budget.

Tonya Harding admits that she knew of plan to attack Nancy Kerrigan
"I didn't abuse any of my children", "Spanked?" You will even get a glimpse at the real Tonya Harding doing the triple axle. Tonya Harding dropped a bombshell Thursday night on the ABC interview special Truth and Lies: The Tonya Harding Story.

Bayer Leverkusen vs. Bayern Munich live stream
The reigning champions controlled the proceedings on the pitch from the kick-off. It's an opening fixture that has the capability to be both thrilling and tough.

Chris Christie gives last major speech as NJ governor
Christie's tenure as a "pretty interesting ride", saying he entered office in 2010 as somewhat of an unknown commodity. The prepared text of his remarks didn't show him invoking the name of his friend, President Donald Trump .

Brexit: Over 14000 jobs endangered jobs in German vehicle industry
Meanwhile, Brexit could cost the United Kingdom almost 500,000 jobs in a worst-case scenario, according to a study commissioned by the Mayor of London.

America 'an idea, not a race,' senator tells President Trump
Trump mentioned each of those nations and regions while discussing immigration policy on Jan 11, according to NBC News. This is according to the person who examined him, presidential physician Rear Admiral Ronny Jackson .