Federal Drug Administration Announces New Safety Labels For Codeine, Hydrocodone

Federal Drug Administration Announces New Safety Labels For Codeine, Hydrocodone

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.

New safety labeling requirements about who should take prescription opioid cough and cold medicines with codeine or hydrocodone are due to roll out following a United States Food and Drug Administration announcement.

Health care professionals should be aware that FDA is changing the age range for which prescription opioid cough and cold medicines are indicated.

According to the announcement, labeling for those medications is also being updated with additional safety warning for adult use notifying users about the risks of misuse, abuse, addiction, overdose, and death, along with slowed or hard breathing.

It is important for parents and caregivers to understand that a cough due to a common cold often does not need medicines for treatment.

The FDA announced yesterday that it is requiring revisions to the safety labeling on such perscription opioid cough and cold medicines. Consider recommending over-the-counter (OTC) or other FDA-approved prescription medicines for cough and pain management in children younger than 12 years and in adolescents younger than 18 years, especially those with certain genetic factors, obesity, or obstructive sleep apnea and other breathing problems.

More news: Green Turtles In Great Barrier Reef Turning Female Because Of Climate Change
More news: 1.03 is Gilead Sciences Inc's (NASDAQ:GILD) Institutional Investor Sentiment
More news: Zuma and President Kenyatta meet to discuss politics and business

Not only will these medications get new safety labeling about the age of users, they will also get new labels about safe use in general, said the FDA.

In any case, there's little that can or should be done to ease most children's cough and colds, the FDA said. 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. Moreover, the risks of using prescription opioid cough products in children of all ages generally outweigh the potential benefits.

So what's the advice for parents who may be using these medicines for their child already? If a cough medicine is prescribed, ask your child's health care professional or a pharmacist if it contains an opioid such as codeine or hydrocodone. According to the FDA, they should talk to their child's doctor about alternative therapies.

Thursday's action expands a previous warning, issued by the agency last April, against the use of prescription medications containing codeine and tramadol for children younger than 12.

The agency urged parents to read the labels on prescription bottles.

Related Articles

  • Chris Brown Could Face Criminal Charges Over Exotic Monkey

    Chris Brown Could Face Criminal Charges Over Exotic Monkey

    Chris Brown has a done a pretty good job at staying out of trouble lately but the singer is once again facing problems. Internet goers believed the monkey was a gift to Royalty and feared for her safety.
    #11 Terrapins Fall to Michigan State

    #11 Terrapins Fall to Michigan State

    Guard Shay Colley had 17 and Sidney Cooks had 10. "I like the fact that we're taking care of the ball". Miles Bridges was held scoreless at the intermission, going 0-for-3 in 13 minutes of work.
    ISD incoming call termination rate slashed

    ISD incoming call termination rate slashed

    An operator charges their rival an Interconnection Usage Charge when a user ends a domestic call on their network. Back in February 2015, TRAI increased the ITC to 53 paise per minute from 40 paise per minute.
  • University of Alabama coach had playbook stolen before the big victory

    University of Alabama coach had playbook stolen before the big victory

    The backpack had $1,300, a laptop, a passport, his phone and the team's playbook for the championship game against Georgia. According to a police report, Karl Dunbar reported the theft on January 6 at the Marriott Marquis.
    Dark Souls: Remastered is coming to several new platforms

    Dark Souls: Remastered is coming to several new platforms

    Its terrors emanate from its very core, each step bringing you closer to another inevitable death. It first released in 2011 on Xbox 360, PS3, and PC as a spiritual successor to Demon's Souls .
    Region's condo prices increase 24%, houses up 12%

    Region's condo prices increase 24%, houses up 12%

    However, we do foresee an upswing in demand in the latter portion of the year, as prospective buyers adjust to the new realities. Royal LePage is a Brookfield Real Estate Services Inc. company, a TSX-listed corporation trading under the symbol TSX:BRE.
  • COLOMBIA: Government Accuses ELN Of Carrying Out Attacks

    COLOMBIA: Government Accuses ELN Of Carrying Out Attacks

    However, the attacks "should not alter the course of the talks to achieve a political resolution to the conflict", the group said. He added that they're seeking a response from the government to see if it is interested in finding a way out of this incident.
    New 'Teen Titans GO' Movie Trailer Released

    New 'Teen Titans GO' Movie Trailer Released

    Teen Titans GO! To The Movies will also feature Will Arnett as the voice of Slade and Kristen Bell as Jade Wilson. The trailer starts off with the Teen Titans giving fans what they know they want - Wonder Woman .
    Government in crisis talks over company that provides vital services to schools

    Government in crisis talks over company that provides vital services to schools

    It said the firm remained in constructive dialogue about short term financing while "longer term discussions are continuing". "Suggestions that Carillion's business plan has been rejected by stakeholders are incorrect", the firm said in a statement.
  • All the Nintendo Direct Mini news and announcements

    All the Nintendo Direct Mini news and announcements

    Even though the teaser doesn't show us any gameplay footage, it does give us an important detail by revealing a release date. Amazon is taking pre-orders for Dark Souls Remastered on Sony PS4 and Microsoft Xbox One for $39.99 each.
    Football coach Barry Bennell 'abused boy 100 times'

    Football coach Barry Bennell 'abused boy 100 times'

    He said he had believed that Mr Bennell could help him realise his dream of playing football professionally for Manchester City. The court was read a transcript of a police interview with Bennell conducted in February 2017.
    Palestinian leader says USA  out of peace talks until Jerusalem policy reversed

    Palestinian leader says USA out of peace talks until Jerusalem policy reversed

    On Tuesday, King Salman of Saudi Arabia said that his country's position on the Palestinian issue remains the same. Jerusalem is considered a holy city by Muslims, Christians and Jews.