FDA issues safety alert for pregnant patients using kidney transplant drug.FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. issued a safety alert Nov. 27 for pregnant patients using the kidney transplant drug Myfortic delayed-release tablets, the agency stated in a release. FDA said it has been determined the medication is associated with increased risks of pregnancy loss and congenital malformations. Officials said the pregnancy category for Myfortic has been changed to Category D -positive evidence of fetal risk. Myfortic, manufactured by Novartis, is indicated for the prophylaxis of organ rejection in patients receiving allogeneic allogeneic /al·lo·ge·ne·ic/ (-je-ne´ik) 1. having cell types that are antigenically distinct. 2. in transplantation biology, denoting individuals (or tissues) that are of the same species but antigenically renal transplants, administered in combination with cyclosporine cyclosporine /cy·clo·spor·ine/ (-spor´en) a cyclic peptide from an extract of soil fungi that selectively inhibits T cell function; used as an immunosuppressant to prevent rejection in organ transplant recipients and to treat severe and corticosteroids Corticosteroids Definition Corticosteroids are group of natural and synthetic analogues of the hormones secreted by the hypothalamic-anterior pituitary-adrenocortical (HPA) axis, more commonly referred to as the pituitary gland. . FDA said a transplant patient planning a pregnancy shouldn't use Myfortic unless she cannot be successfully treated with other immunosuppressant drugs. |
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