Drug | Clinical indication | Fetal effects | ETASU |
Riociguat (Adempas) | Pulmonary arterial hypertension | Preclinical animal studies demonstrated increased pregnancy loss and congenital cardiac defects. | Yes |
Ambrisentan (Letairis) | Pulmonary arterial hypertension | Preclinical animal studies demonstrated cardiopulmonary, facial and thyroid congenital defects. | Yes |
Bosentan (Tracleer) | Pulmonary arterial hypertension | Preclinical animal studies demonstrated cranial, orofacial and cardiopulmonary congenital defects. | Yes |
Isotretinoin (Accutane) | Cystic acne | Congenital defects of the face, ears, heart and brain | Yes |
Mycophenolate (Cellcept and Myfortic) | Solid organ transplant and autoimmune disease | Congenital defects of the face and ears | Yes |
Macitentan (Opsumit) | Pulmonary arterial hypertension | Preclinical animal studies demonstrated cardiac and orofacial congenital defects. | Yes |
Pomalidomide (Pomalyst) | Multiple myeloma | Preclinical animal studies suggest congenital defects similar to those caused by thalidomide. | Yes |
Lenalidomide (Revlimid) | Multiple myeloma | Preclinical animal studies suggest congenital defects similar to those caused by thalidomide. | Yes |
Thalidomide (Thalomid and Celgene) | Multiple myeloma | Phocomelia and other congenital defects | Yes |
Topiramate+phentermine (Qsymia) | Weight loss | Orofacial defects | Yes |
ETASU, elements to assure safe use.