Risk Evaluation and Mitigation Strategies (REMS) for drugs in pregnancy
| 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.