US FDA ap­proves OxyCon­tin for chil­dren aged 11 and older

The China Post - - LIFE -

The U. S. Food and Drug Ad­min­is­tra­tion ( FDA) on Thurs­day ap­proved the pow­er­ful painkiller OxyCon­tin for a new use in chil­dren 11 to 16 who are suf­fer­ing from se­vere, long- term pain.

OxyCon­tin is an ex­tended- re­lease opi­oid that has long been used to treat around- the- clock pain in adults. But most pain med­i­ca­tions are not ap­proved for use in chil­dren.

The FDA says it asked drug­maker Pur­due Pharma to study how to safely use OxyCon­tin in chil­dren.

“This pro­gram was in­tended to fill a knowl­edge gap and pro­vide ex­pe­ri­enced health care prac­ti­tion­ers with the spe­cific in­for­ma­tion they need to use OxyCon­tin safely in pe­di­atric pa­tients,” Sharon Hertz, an FDA drug di­vi­sion di­rec­tor, wrote in an online post.

Un­der the new ap­proval, doc­tors are di­rected to only pre­scribe OxyCon­tin to chil­dren who can al­ready tol­er­ate a min­i­mum dose of 20 mil­ligrams of oxy­codone, the drug in­gre­di­ent in OxyCon­tin. Tak­ing a sud­den dose of an opi­oid can lead to over­dose and death if pa­tients haven’t pre­vi­ously been ex­posed to the drug type.

The FDA notes that the Dura­gesic patch, which re­leases fen­tanyl, is the only other opi­oid ap­proved for chil­dren.

OxyCon­tin was re- for­mu­lated in 2010 to dis­cour­age pa­tients from crush­ing the tablets for snort­ing or in­jec­tion. Pur­due Pharma dis­con­tin­ued the older ver­sion of its block­buster drug, which was long as­so­ci­ated with prob­lems of ad­dic­tion, over­dose and death.

The FDA notes that the same health warn­ings that ap­ply to adults ap­ply to chil­dren tak­ing OxyCon­tin. Physi­cians should not com­bine the drug with any other med­i­ca­tions that can add to its se­dat­ing ef­fects, which could lead to breath­ing dif­fi­cul­ties.

As a con­di­tion of ap­proval, the FDA is re­quir­ing Stam­ford, Con­necti­cut- based Pur­due to con­duct a fol­low- up study ex­am­in­ing rates of in­jury, over­dose, ac­ci­dents and med­i­ca­tion er­rors in pa­tients ages 11 to 17. The fi­nal study is due April 2019.

Doc­tors pre­scribe opi­oids for a wide range of ail­ments, from post- sur­gi­cal pain to arthri­tis and mi­graines. Med­i­cal ex­perts con­tinue to dis­agree over the ap­pro­pri­ate role of the drugs, with some ar­gu­ing that they should be re­served for the most se­vere cases, such as can­cer pain or end- of- life care.

The FDA men­tions se­vere pain due to trauma, surgery or can­cer as po­ten­tial uses for opi­oids in chil­dren.

OxyCon­tin was the first in a class of long- act­ing opi­oids de­signed to de­liver pow­er­ful, around- the- clock pain re­lief. The pills and tablets are for­mu­lated to slowly re­lease their drug con­tents over 12 or more hours. But abusers of­ten try to get a mas­sive, heroin- like high by re­leas­ing the en­tire dose at once via chew­ing, snort­ing or in­ject­ing crushed tablets’ con­tents.

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