FDA warns against us­ing 2 opi­oids on kids

Sun Sentinel Broward Edition - - NATION & WORLD - By Lau­rie McGin­ley The Wash­ing­ton Post

WASH­ING­TON — The Food and Drug Ad­min­is­tra­tion onThurs­day sharply ratch­eted up its warn­ings against giv­ing chil­dren pre­scrip­tion codeine and tra­madolmedicines, say­ing the drugs could cause se­vere breath­ing prob­lems and death in young­sters who me­tab­o­lize the drugs at a faster-than-nor­mal rate.

The agency said it would re­quire man­u­fac­tur­ers to make la­bel changes to warn that the drugs shouldn’t be used for any­one younger than 12 and should be re­stricted in older chil­dren. The FDA also warned breast-feed­ing moth­ers to avoid us­ing the medicines while nurs­ing their ba­bies.

Codeine and tra­madol are opi­oid med­i­ca­tions used to treat pain. Codeine also is used in cough and cold reme­dies and some­times is com­bined with other med­i­ca­tions, such as ac­etaminophen.

Tra­madol only to treat is ap­proved pain in adults, but data show it is be­ing used in chil­dren and ado­les­cents, the FDA said.

Dou­glas Throck­mor­ton, a top of­fi­cial at the FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search, said in tele­phone brief­ing for re­porters that the safety haz­ards are the re­sult of the “unique way” th­ese med­i­ca­tions are bro­ken down in the bod­ies of some chil­dren and adults.

He said that “ul­tra­ra­pid me­tab­o­liz­ers” process the drugsmuch­faster than usual, re­sult­ing in dan­ger­ously high lev­els that can de­press breath­ing and lead to death. Th­ese peo­ple have a ge­netic fea­ture that prompts the liver to con­vert codeine into life-threat­en­ing or fatal amounts of mor­phine in the body.

The ma­jor­ity of se­ri­ous side ef­fects oc­curred in chil­dren younger than 12, some­times af­ter a sin­gle dose, the FDA said.

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.


The FDA is in­creas­ing warn­ings about the dan­gers of two painkillers, warn­ing against their use in chil­dren.

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