TABLE 4.
Individual case safety reports of pregnancy loss with ranibizumab.
| No | Age | Drug | Indication | Adverse event | Report year and quarter |
|---|---|---|---|---|---|
| 1 | NA | Ranibizumab (PS) | Pseudoxanthoma elasticum | Abortion spontaneous | 2008 Q1 |
| 2 | NA | Ranibizumab (PS) | Product used for unknown indication | Abortion spontaneous | 2010 Q3 |
| 3 | NA | Ranibizumab (PS) | Product used for unknown indication | Abortion spontaneous | 2011 Q2 |
| 4 | 28 | Ranibizumab (PS) | Choroidal neovascularisation | Abortion spontaneous, Chorioretinal disorder, Visual acuity reduced | 2011 Q3 |
| 5 | 33 | Ranibizumab (PS/SS) | Retinal vein occlusion | Abortion | 2011 Q4 |
| 6 | 26 | Ranibizumab (PS) | Diabetic retinal oedema | Abortion spontaneous | 2014 Q2 |
| 7 | 46 | Ranibizumab (PS/SS), ACTOVEGIN™ (C), Ofloxacin (C) | Retinal vein thrombosis | Abortion spontaneous | 2014 Q2 |
| 8 | 27 | Ranibizumab (PS), Dexamethasone (C) | Retinal vein thrombosis, Retinal vein occlusion | Abortion spontaneous | 2015 Q1 |
| 9 | NA | Ranibizumab (PS/SS), Levothyroxine sodium (C) | Pathologic myopia, Choroidal neovascularisation | Abortion spontaneous | 2015 Q4 |
| 10 | NA | Ranibizumab (PS/SS) | Diabetic retinopathy, Diabetic retinal edema | Abortion spontaneous | 2015 Q4 |
| 11 | 42 | Ranibizumab (PS/SS) | Macular oedema | Abortion | 2016 Q2 |
| 12 | NA | Ranibizumab (PS) | Product used for unknown indication | Abortion spontaneous | 2016 Q2 |
| 13 | 34 | Ranibizumab (PS) | Product used for unknown indication | Abortion spontaneous | 2018 Q4 |
| 14 | NA | Prednisolone (PS), Ranibizumab (SS), Azathioprine (SS) | Chorioretinitis, Antiangiogenic therapy | Premature separation of placenta, Stillbirth, Product use in unapproved indication | 2021 Q2 |
| 15 | NA | Ranibizumab (PS/SS), Prednisolone (SS), Azathioprine (SS) | Chorioretinitis, Choroiditis, Antiangiogenic therapy | Premature separation of placenta, Stillbirth, Product use in unapproved indication | 2021 Q2 |
| 16 | NA | Azathioprine (PS), Ranibizumab (SS), Prednisolone (SS) | Choroiditis | Premature separation of placenta, Foetal death | 2021 Q2 |
| 17 | NA | Azathioprine (PS), Ranibizumab (SS), Prednisolone (SS) | Choroiditis | Premature separation of placenta, Foetal death, Product use in unapproved indication | 2021 Q2 |
| 18 | 32 | Ranibizumab (PS/SS) | Choroidal neovascularisation | Abortion missed | 2021 Q3 |
| 19 | 38 | Ranibizumab (PS) | Diabetic retinal oedema | Abortion spontaneous | 2021 Q3 |
Abbreviations: C, Concomitant; NA, not available; PS, primary suspect drug; SS, secondary suspect drug. Pregnancy-related exposure preferred terms are omitted.