FDA warns against giving kids two potent painkillers: codeine, tramadol

codeineWhen severe colds, flu, or other infections run down youngsters with bad aches or an unrelenting hack, worried parents and doctors may turn to potent painkillers and cough suppressants. But the federal Food and Drug Administration has issued its strongest warnings about key ingredients in some of these, saying kids should not receive medications containing codeine or tramadol.

Both are powerful opioid painkillers. Prescription cough syrups often contain codeine. Tramadol typically is a drug given only to adults, though the FDA says it is seeing it prescribed more often, off label, to kids. Both tramadol and codeine have been prescribed for post-surgery pain for youngsters who have had their tonsils or adenoids removed.

But children, especially those 12 and younger, can have severe reactions to codeine and tramadol. They can slow or labor their breathing.

The agency identified codeine-related breathing problems in patients younger than 18, between January 1969 and May 2015, in 64 cases, including 24 deaths. Between January 1969 and March 2016, the FDA found nine cases of breathing problems, including three deaths, involving tramadol in patients younger than 18. Some of the incidents resulted from a single dose of the drugs.

The FDA long has expressed concern about kids and painkillers, monitoring and restricting codeine and tramadol before. The agency moved its warnings about them and youngsters to the highest level as evidence mounted about how they process the drugs differently and can be harmed by them.

Mothers, the FDA noted, should know that they can pass the risky drugs to their babies by breast feeding. Parents also should be wary of the drugs with older kids, those ages 12 to 18, if the kids are obese or have breathing conditions like sleep apnea. Grown-ups may need to read prescription pain or cough medication labeling closely to ensure that codeine or tramadol aren’t included ingredients.

In my practice, I see the major harms that babies and children can suffer from bad or negligent medical care, and I encounter too many instances where patients suffer injuries due to dangerous drugs. It’s disconcerting that doctors, off label, keep prescribing drugs with a big wallop for adults too often to tiny babies and infants. As the nation battles an epidemic of opioid drug abuse, it’s hard to fathom why doctors needed to be ordered to sharply limit two of these powerful painkillers’ use for kids. But good for the FDA for stepping in.

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