FDA Announces Restrictions on Prescriptions Containing Codeine, Tramadol

FDA Announces Restrictions on Prescriptions Containing Codeine, Tramadol

FDA Announces Restrictions on Prescriptions Containing Codeine, Tramadol

On Thursday, the FDA said it will require that prescription drugs containing codeine or tramadol carry a warning on the label against using them in children under 12 or in women who are breast-feeding. Since 2013, prescription codeine labeling has contained a Boxed Warning and Contraindication for children up to age 18 years of age regarding the risk of life-threatening respiratory depression following the use of codeine for pain management after the removal of the tonsils (tonsillectomy) and/or adenoids (adenoidectomy).

In a report published a year ago in the journal Pediatrics, members of the academy's committee on drugs wrote that although over-the-counter cough and cold medicines containing codeine were available in 28 states and Washington, D.C., "neither the value of suppressing cough nor the effectiveness of codeine in children with acute illnesses has been shown".

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.

Codeine and tramadol are a type of narcotic medicine called opioid.

This is especially concerning in children under 12 years of age and adolescents who are obese or have conditions that may increase the risk of breathing problems, like obstructive sleep apnea or lung disease.

Unlike codeine, tramadol wasn't FDA-approved for pediatric patients; however, in September 2015, the agency noted it was likely being used off-label in children. And the FDA also says such drugs can be unsafe to youths between 12 and 18.

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The move follows Australia's rescheduling of OTC codeine-containing medicines to prescription-only, set to take place on 1 February 2018; New Zealand may be considering doing something similar.

Tramadol, another opioid painkiller, was also mentioned in the most recent FDA warning. The agency also found, in a review of the medical literature, a report of an infant who died after being exposed to codeine while breast-feeding. Since some medicine contains narcotics like codeine and tramadol that are proven to be fatal to kids.

"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. Between January 1969 and March 2016, there were nine cases of breathing problems including three deaths, involving the use of tramadol in children younger than 18.

Codeine is an opioid prescribed for pain relief but is also combined with other medications, such as cough and cold medicines.

Unlike adults, some children don't metabolize the drug, which prompts adults to give a higher dose in order for the medication to be effective.

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