Pregnant Women and Xarelto
There have been as yet no extensive human studies of the effect of Xarelto (rivaroxaban) for women who are pregnant. However, there are indications in animal studies that the drug may not be the best option for pregnant women. Extremely high doses of Xarelto resulted in bleeding, miscarriages, or low birth weight in pregnant rabbits and rabbits. The Food and Drug Administration (FDA) has classified the drug as Category C, meaning that the potential for risk to a human mother and fetus is unknown, but have resulted in adverse effects in animal subject, and not recommended unless the benefits outweigh the possible danger.
Xarelto is typically prescribed for patients with atrial fibrillation, non-valvular atrial fibrillation, deep vein thrombosis, and as post-surgical treatment following hip or knee replacement. If a woman who is taking Xarelto becomes pregnant, it may be necessary to discontinue the treatment. It will all depend on what the attending physician believes is in the best interest of the patient.
There are other options that are considered safe for pregnant women with blood clot problems such heparin, but there may be instances where the patient is unable to switch to available alternative medication because of an allergic or other adverse reaction. In such cases, Xarelto may still be a viable option.
It is important to note that a Category C medication may still be safe to use despite the discouraging results of animal studies because animals don’t always have the same reaction to drugs as humans. It is a case of loading the dice on the part of the FDA; ultimately it will boil down to the needs of the mother.
However, as discussed on the website of the lawyers at Williams Kherkher, Xarelto poses an increased risk of uncontrollable bleeding in all patients, pregnant or not. There have already been claims that the drug is inherently too dangerous to be taken, and that drug distributor Janssen Pharmaceutical and maker Bayer AG knew or should have known that the risks outweighed the benefits of taking the drug. If you were prescribed with Xarelto, and you or your baby sustained some serious injury as a result, you may have a case against one or both companies. Consult with a dangerous drug lawyer familiar with Xarelto to find out more about your legal options.