tiptrot.com
tiptrot.com August 16, 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

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.

Poll Finds Donald Trump's Support Inching Up to 50 Percent
The results represent a significant turnaround from February, when 62% said they saw Trump as someone who keeps his promises. The poll, which was conducted on 5-9 April, show that 45% of Americans believe Trump "keeps his promises".

Funeral for Robert Godwin, Sr. scheduled for Saturday
Owner Blake Frederick says suspect Steve Stephens visited Sherwin Shooting Sports within the past year. The online video reportedly stayed on Facebook for nearly three hours before it was taken down.

NCAA Returns Events to NC After State Rolls Back LGBT Law
The bill was signed shortly before an NCAA deadline that would have forced the state to wait longer to host events in the future. In response, the NCAA disqualified North Carolina from hosting neutral-site championship events for the 2016-17 academic year.

'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.

NFL Notes: Pats expected to open season vs. Chiefs
A fourth-round draft pick of the Patriots in 2015, White played in all 16 games this past season for the first time in his career. While we have seen Super Bowl rematches occur in Week 1 many times in recent years, it seems that it won't be happening in 2017.

Bruins lose in OT again; Senators grab series lead
The Senators outshot the Bruins 10-3 in the first , taking advantage of several defensive breakdowns on their side of the ice. His return means Tommy Cross will likely be scratched after making his playoff debut in Game 3.

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.

Kashmir colleges, universities to remain shut on Tuesday
On Saturday, as many as 50 students were injured in clashes with local police and paramilitary forces; some were hit by pellets. Students of the S P College in Srinagar blocked the Maulana Azad Road on Monday as police used tear smoke in a bid to clear it.

Mexican's immigration status is in dispute over deportation
He had minor run-ins with the law, four convictions to be exact: one for shoplifting and three for driving without a license. Montes allegedly tried to retrieve his wallet in a friend's auto and was unable to provide proof of his DACA status.