Miscarriages Caused by Blood Coagulation Protein or Platelet Deficits Medication
- Author: Rodger L Bick†, MD, PhD, FACP; Chief Editor: Emmanuel C Besa, MD more...
Medication Summary
See the 2002 US-FDA Medwatch Alert regarding Lovenox. The alert is summarized below.
Prosthetic heart valve warnings
Lovenox Injection is not recommended for patients with prosthetic heart valves for thromboprophylaxis. Prosthetic heart valve thrombosis has been reported in these patients, some of whom were pregnant women in whom thrombosis led to maternal and fetal deaths. The thromboembolism risk may be higher in pregnant women with prosthetic heart valves (see Pregnancy Precautions, below).
Pregnancy precautions
- Teratogenic effects: Congenital anomalies in infants of women who received enoxaparin during pregnancy include cerebral anomalies, limb anomalies, hypospadias, peripheral vascular malformation, fibrotic dysplasia, and cardiac defect. The incidence is not higher than in the general population, and cause and effect are not established.
- Nonteratogenic effects
- Fetal deaths have occurred in pregnant women who received Lovenox Injection. A cause-and-effect relationship has not been established in these cases. Pregnant women who take anticoagulants, including enoxaparin, have a greater risk for bleeding at any site, which may lead to fetal or maternal death. Carefully monitor pregnant women on enoxaparin. Inform pregnant women and women with childbearing potential of the potential hazard of enoxaparin in pregnancy to the mother and fetus.
- In one clinical study of pregnant women with prosthetic heart valves, maternal and fetal death occurred in 2 of 7 women given enoxaparin (1 mg/kg bid) to reduce the risk of thromboembolism in whom clots formed that blocked their prosthetic heart valves. Prosthetic valve thrombosis has occurred in pregnant women with prosthetic heart valves who were taking enoxaparin for thromboprophylaxis, resulting in maternal death or surgical interventions. Lovenox Injection is not recommended for thromboprophylaxis in pregnant women with prosthetic heart valves (see Prosthetic Heart Valve Warnings, above).
Adverse reactions and ongoing safety surveillance
Since 1993, more than 80 incidents of epidural or spinal hematoma formation have been reported with spinal/epidural anesthesia or spinal puncture in patients receiving Lovenox Injection.
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| Patient Characteristics (All 351 Patients) | Mean | Standard Deviation | Maximum | Minimum |
| Age, y | 33.3 | 5.63 | 49 | 18 |
| Number of Miscarriages | 2.9 | 2.39 | 9 | 2 |
| Antiphospholipid Found | Patients With APLS, % |
| ACLA-IgG only | 32.6 |
| ACLA-IgM only | 23.4 |
| ACLA-IgA only | 7 |
| ACLA-IgG + IgM | 3 |
| ACLA-IgG + IgA | 1 |
| ACLA IgA + IgM | 0 |
| Lupus anticoagulant only | 2 |
| ACLA + lupus anticoagulant | 2 |
| Subgroup Only (No ACLA or lupus anticoagulant present) | |
| Antiphosphatidylserine | 4 |
| Antiphosphatidylinositol | 2 |
| Antiphosphatidylethanolamine | 5 |
| Antiphosphatidic acid | 5 |
| Antiphosphatidylcholine | 7 |
| Antiphosphatidylglycerol | 1 |
| Anti–annexin-V | 5 |
| B2GP1 | 0 |
| Hexagonal phospholipid | 0 |
| Total | |
| (9 Patients had ACLA + a subgroup antibody) | |
| Total with only a subgroup antibody | |
| APLS patients with only a subgroup antibody, % | 29 |

