Health Care

FDA further restricts pain medication use in kids

FDA further restricts pain medication use in kids”

A strengthened warning to mothers that breastfeeding is not recommended when taking codeine or tramadol medicines due to the risk of serious adverse reactions in breastfed infants, which can include excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death.

Furthermore, the FDA also added that children ages 12 to 18 should also be warned against the use of medicine codeine or tramadol.

The agency noted that since 2013, prescription products containing codeine have contained a boxed warning and contraindication for children and teens up to age 18 for pain management after removal of tonsils and adenoids. The FDA is ordering major label changes on prescription drugs containing codeine and tramadol-a requirement that will affect dozens of companies, ranging from giants like Johnson & Johnson to lesser-known names like Vertical Pharmaceuticals of Bridgewater, New Jersey.

Throckmorton said that the agency was both increasing restrictions on the products' labels and issuing a warning to consumers and pediatricians because of new information and concerns about the drugs' risks. These people have a genetic feature that prompts the liver to convert codeine into life-threatening or fatal amounts of morphine in the body. Tramadol is a prescription drug approved only for use in adults to treat moderate to moderately severe pain.

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The FDA hasn't approved tramadol for use in children. They include the FDA's strongest warning, a "contraindication", specifying that tramadol should not be used in children who have had their tonsils removed.

The agency listed 15 medicines affected by the action, plus all of their generics, which included J&J's Tylenol with codeine and Vertical's tramadol med ConZip.

The US Food and Drug Administration warned the public on Thursday regarding the use of certain medications containing narcotics. They also can ask their doctor or pharmacist if a specific medication contains codeine or tramadol.

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.

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"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. In addition, the Agency is considering more regulation surrounding OTC codeine products that are available in some states.

Conclusively, parents should actively check for any warning labels on medication that they plan to give to their children.

Atlanta pediatrician Dr. Maia Walton said she rarely prescribes opioid pain medications to her patients.

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