Anticoagulation of pregnant women with mechanical heart valves.

The management of pregnant women with mechanical heart valves is challenging. Recently, based on small numbers of patients and poor-quality data, correspondence from Aventis Pharmaceuticals Inc has described treatment "failures" and concerns about teratogenicity with the use of the low-molecular-weight heparin (LMWH) enoxaparin. The company issued a "Warning" that enoxaparin should not be used in patients with prosthetic heart valves and a "Precaution" about potential teratogenicity. This has created a huge problem for physicians managing pregnant women with prosthetic heart valves because the alternatives, unfractionated heparin and warfarin, are problematic. There have been case reports of failures (including death from thrombosed valves) with unfractionated heparin, whereas the package insert for warfarin states that the drug is contraindicated during pregnancy because of potential teratogenicity. Initially, LMWHs appeared suitable for pregnant patients with prosthetic heart valves. Unfortunately, the company correspondence, presumably supported by the Food and Drug Administration (FDA), raises medicolegal concerns with use of any LMWH. We believe that pharmaceutical companies and the FDA should not endorse scientifically unsupported claims that eliminate acceptable therapeutic options. This correspondence has created considerable confusion among patients and treating physicians and is likely to lead to frivolous lawsuits and preclude the performance of properly designed trials in pregnant women. We believe a consensus conference among experts in the field to identify key unresolved issues and a commitment by the FDA and industry to perform appropriate studies are now critical.