tiptrot.com
tiptrot.com December 11, 2017


FDA further restricts pain medication use in kids

22 April 2017, 01:48 | Nichole Osborne

FDA further restricts pain medication use in kids

FDA further restricts pain medication use in kids

Parents shouldn't give their children any medications containing the narcotics codeine or tramadol, because they can cause life-threatening breathing problems, the U.S. Food and Drug Administration warned Thursday.

Some children and adults are genetically predisposed to process opioid drugs more quickly, the FDA said.

FDA's review of adverse event reports submitted to the agency from January 1969 to May 2015 identified 64 cases of serious breathing problems, including 24 deaths, with codeine-containing medicines in children younger than 18 years.

To view the full article, register now.

Now, labels for both codeine and tramadol are being updated to include additional Contraindications and Warnings; among the updates are Contraindications for use of codeine or tramadol in all children younger than 12 years of age, warnings about their use in children 12-18 years of age with certain medical conditions, and a stronger warning recommending against their use in nursing mothers. Codeine labeling already warns against post-surgical use for kids. The new warning further limits the agency's previous restriction of codeine use in children younger than age 18.

Almost 1.9 million kids aged 18 or younger received a prescription for a codeine-containing medication in 2014, and almost 167,000 were prescribed a medication containing tramadol, the FDA said.

"We understand that there are limited options when it comes to treating pain or cough in children and that these changes may raise some questions for healthcare providers and parents", explained Throckmorton.


Nursing mothers who are taking codeine or tramadol can pass unsafe levels of opioids to their babies through breast milk.

Tramadol is a prescription drug that is only approved for adults to treat pain, the agency noted.

Regarding codeine use during breastfeeding, a literature search revealed numerous cases of respiratory depression and sedation, including one infant death, especially in mothers who have the CYP2D6 ultra-rapid metabolizer genotype.

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

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".

Aside from breathing issues, codeine also causes nausea, vomiting, abdominal pain, constipation, and skin allergies.

For more on opioid medications in pediatrics, visit the Boston Children's Hospital. The FDA recommends that parents talk to a doctor before giving their children such drugs and notes that colds and coughs in kids "are generally mild and go away in a few days, so they may not need to take any medicine".



Other News

Trending Now

Here's What Trump's 'Buy American, Hire American' Order Means
At one debate, he called for fully ending the program, saying: "It's very bad for our workers and it's unfair for our workers. The commerce secretary will review how to close loopholes in existing rules and provide recommendations to the president.

Trump administration says no US trading partners manipulate currency
No countries were determined to have met all three of these criteria, but Japan , South Korea, Taiwan, Germany and Switzerland all met two of them.

Britons can show EU preferences in election -EU's Verhofstadt
Then EBA was set up in 2011 to increase transparency in the European financial system and conduct stress tests on lenders. The Prime Minister has used her Easter message to speak out about the right of Christians to speak out about their faith.

Netflix on the verge of hitting 100 million subscribers
Be proactive - Use the "Flag as Inappropriate" link at the upper right corner of each comment to let us know of abusive posts. Netflix didn't add as many new users in the last quarter as investors had been expecting, both in the USA and internationally.

Giants to open in Dallas for third straight season
We hope to avoid a Thursday night dud with Chiefs-Raiders in an AFC West showdown that could prove huge in the playoff race. After an 11-5 regular season and numerous records set in the process, the Falcons made a run all the way to Super Bowl LI.

White House, Pentagon miscommunicated on aircraft carrier's location
The Trump White House either lied about the aircraft carrier, or were lied to, and didn't care enough to check on the truth. President Donald Trump the next day said on the Fox Business Network that 'we are sending an armada. "We have submarines.

Berkeley Cancels Planned Ann Coulter Event; She Still Plans To Speak
Ann Coulter's planned appearance at the University of California, Berkeley next week has been called off for security concerns. The Berkeley administrators cited these events in their email about the decision to cancel Coulter.

Kathrine Switzer, first woman to officially run Boston Marathon, back in race
Keflezighi, 41, said he plans to enter the New York Marathon , which he won in 2009, one last time in the fall before retiring. At the time , she didn't think it was a big deal since another woman ran the race without a number the year before.

WWE Smackdown main event (live coverage tonight)
Mahal won a number one contender's match on tonight's SmackDown to advance to Backlash, where he'll challenge for the title. Randy Orton came out and congratulated Mahal, but said his prize won't be the WWE Championship, it will just be an RKO.

'John: 316' allegedly written on Hernandez's forehead when he was found dead
Sources told WCVB that the correction officer who was responsible for doing the rounds that morning is now on paid leave. Hernandez was found dead early Wednesday, hanging by a bedsheet in his cell at the Souza Baranowski Correctional Center.