FDA Determines Codeine, Tramadol Unsafe For Children

Apr 22, 2017, 01:42
FDA Determines Codeine, Tramadol Unsafe For Children

The Food and Drug Administration on Thursday sharply ratcheted up its warnings about giving children prescription medicines with codeine and tramadol, saying the drugs could cause severe breathing problems and death.

Douglas Throckmorton, MD, deputy center director for regulatory programs, Center for Drug Evaluation and Research said in a statement that they have discovered that some children who take medicine containing codeine or tramadol have experience life-threatening respiratory depression and even death. The new warning further limits the agency's previous restriction of codeine use in children younger than age 18.

FDA announced Thursday that it is restricting the use of codeine and tramadol medicines in children.

More news: Scientists Discover Planet Likely to Have Alien Life

Codeine is a narcotic painkiller and cough suppressant with similar effects to morphine and hydrocodone, which are strong opioid medication. Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults. There are serious risks associated with the drugs, including slowed or hard breathing and death, which appear to be a greater risk in children younger than aged 12 years.

In a related safety memo, the FDA explained that all manufacturers of codeine and tramadol would be required to add several new warnings to their labels. Codeine labeling already warns against post-surgical use for kids. For children ages 12-18, and for breastfeeding mothers, the FDA said, the use of these medications should be limited. Besides a change saying that the drugs shouldn't be used in children under 12, the mandated changes include a new warning for tramadol saying it shouldn't be used in children younger than 18 for post-surgical pain after the removal of tonsils and adenoids.

"Today's actions build on a better understanding of this very serious safety issue, based on the latest evidence", Throckmorton said. It also identified three deaths and six other cases of serious breathing problems reported between January 1969 and March 2016 in children taking tramadol.

More news: North Korea rolls out missiles, other weaponry at parade

At the time, pharmacist Maria Pruchnicki, an associate professor at the Ohio State University College of Pharmacy, told NPR's Rob Stein, "My concern, were I to be prescribing codeine in children, would be that I would, frankly, kill them".

For more on opioid medications in pediatrics, visit the Boston Children's Hospital. According to the FDA's public label database, more than 100 medications containing codeine are approved for sale without a prescription in the U.S.

Parents should also discuss alternative pain medications for their kids with their doctors, as well as effective cough and cold remedies that do not contain opioids, the FDA said.

More news: Trump claims immunity as president from protesters' lawsuit

YOU MIGHT ALSO LIKE
  • Kids make quick work out of Easter egg hunts in Billings

    The Hooker Chamber of Commerce will be hosting an Easter Egg Hunt April 15 from 1 p.m.to 2 p.m.at the chamber building at 102 E. The kids can redeem the eggs at the matching store to receive prizes such as money, candy and small gifts.

    New England Patriots sign Mike Gillislee, re-sign Malcolm Butler

    I was hoping he would be out of Tennessee a couple years ago just to experience something different. The Cajun Cannon also said he thinks trading the #32 overall pick for Butler would be a good idea.

    Carmelo Anthony and La La Anthony Separated

    There are no plans for either parent to move and they have no desire to uproot their 10-year-old son from his life in NY . La La and Carmelo Anthony have reportedly made a decision to separate after seven years of marriage.
  • NYC Plans To Raise Cigarette Prices To Highest In Nation

    NYC Plans To Raise Cigarette Prices To Highest In Nation

    While no current dealers will lose their license, new licenses wouldn't be issued until the total decreases below the cap. The proposal also advocates the creation of a retail license for e-cigarettes, as well as limiting the number of sellers.
    Microsoft Authenticator App Now Supports Phone Sign-in for Microsoft Accounts

    Microsoft Authenticator App Now Supports Phone Sign-in for Microsoft Accounts

    That app, officially known as Microsoft To-Do (codenamed "Project Cheshire") has been in private testing for close to a year. Only after things get settled with Microsoft To-Do, and the company gets confident over the new product, they will let fall.
    Honda's Clarity EV trio is complete: All-electric and Plug-in Hybrid debut

    Honda's Clarity EV trio is complete: All-electric and Plug-in Hybrid debut

    However, it's now only available in California where the foundations of a hydrogen refilling infrastructure are slowly being laid. Honda has set a target of selling 75,000 Clarity cars - fuel cell, hybrid, or all-electric - annually, starting next year.
  • Wizards' Ian Mahinmi to miss at least Games 3, 4 at Hawks

    Nene also had another strong game , as he made all three of shots for seven points to go along with five rebounds. Atlanta's backcourt is simply too inexperienced to compete with a pair of All-Stars at the peak of their careers.
    The latest from the Shanghai auto show

    The latest from the Shanghai auto show

    Lex Kerssemakers, CEO of Volvo Car USA, said in March that he was pushing for its first electric car to fall in the $40,000 range. Volvo's first electric auto will have a 100 kWh battery and be manufactured at its factory in Luqiao, China.
    Hundreds of Palestinian prisoners launch mass hunger strike

    Hundreds of Palestinian prisoners launch mass hunger strike

    The strike is expected to expand to 2,000 prisoners Monday, Israeli newspaper Haaretz reported. According to Barghouti, the hunger strike is meant to end these alleged abuses by Israel.
  • Trump targets visa program he says hurts American workers

    The order specifically asks the secretary to review waivers of these rules that exist in free-trade agreements. As per several USA reports, a majority of the H-1B visas every year is grabbed by Indian IT professionals.

    The Meggitt plc (MGGT) Earns "Overweight" Rating from Barclays PLC

    On Tuesday analysts at HSBC reiterated Barclays PLC's (LON:BARC) shares as "Buy" in a research note issued to investors. The stock of Ithaca Energy Inc (LON:IAE) has "Outperform" rating given on Wednesday, January 20 by RBC Capital Markets.
    Ben and Jen reunite for Easter

    Ben and Jen reunite for Easter

    The couple became separated in June 2015 but have stayed out of the spotlight for most of the time since. Ben Affleck and Jennifer Garner were married in 2005 and have three children.
popular