Propoxyphene: Withdrawal - Risk of Cardiac Toxicity

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Ppxyphene: Withdawa - isk f adia Txiity


FDA ntified heathae pfessinas that Xandyne Phamaetias has ageed t withdaw ppxyphene, an piid pain eieve sed t teat mid t mdeate pain, fm the .S. maket at the eqest f the FDA, de t new data shwing that the dg an ase seis txiity t the heat, even when sed at theapeti dses. FDA nded that the safety isks f ppxyphene tweigh its benefits f pain eief at emmended dses. FDA eqested that the genei manfates f ppxyphene-ntaining pdts emve thei pdts as we.
FDA’s emmendatin is based n a avaiabe data inding data fm a new stdy that evaated the effets that ineasing dses f ppxyphene have n the heat . The ests f the new stdy shwed that when ppxyphene was taken at theapeti dses, thee wee signifiant hanges t the eetia ativity f the heat: pnged P inteva, widened QS mpex and pnged QT inteva. These hanges an inease the isk f seis abnma heat hythms.

FDA emmends that heathae pfessinas stp pesibing and dispensing ppxyphene-ntaining pdts t patients, ntat patients enty taking ppxyphene-ntaining pdts and ask them t disntine the dg, infm patients f the isks assiated with ppxyphene, and disss atenative pain management stategies

.S. Fd & Dg Administatin (FDA