Hi cuccina,
Pregnancy alone causes women to be in a more hypercoagulable
state. This means pregnant women are more prone to clotting disorders
than non-pregnant women. Should they have a certain genetic makeup
that further increases clotting problems, these women become even more
at risk for clotting disorders and miscarriage. This genetic disorder
is called methylene hydrofolate reductase (MTHFR). I have posted a
link to a paper on the topic below. Note - The fact that some
preganant women take Lovenox does NOT indicate they DO have this
disorder, and I have included this for your information only.
Lovenox
=======
Lovenox (enoxaparin sodium), also known as Clexane, is a heparin based
anticoagulant.
http://en.sanofi-aventis.com/group/products/p_group_products_cardio_lovenox.asp
Lovenox can inactivate the clotting function of and decrease the
numbers of platelets in the blood, and may cause bleeding. Side
effects of Lovenox include:
Bleeding or oozing from surgical wound
Any other bleeding episodes; for example, bleeding at the site of the
injection, nosebleeds, blood in your urine, or if you cough or vomit
blood
Spontaneous bruising (a bruise not caused by a blow or any apparent reason)
Pain or swelling in any part of your leg, foot, or hip
Dizziness, numbness, or tingling
Rapid or unusual heartbeat
Chest pain or shortness of breath
Vomiting, nausea, or fever
Confusion
http://www.lovenox.com/consumer/about/questions1.do#side-effects
The FDA put out the following alert, in 2002. I am posting brief
excerpts from the paper:
?Prosthetic Heart Valves: The use of Lovenox Injection is not
recommended for thromboprophylaxis in patients with prosthetic heart
valves?
?In the PRECAUTIONS section, Pregnancy subsection a new paragraph has
been added to the Teratogenic Effects subsection regarding congenital
anomalies:
There have been reports of congenital anomalies in infants born to
women who received enoxaparin during pregnancy including cerebral
anomalies, limb anomalies, hypospadias, peripheral vascular
malformation, fibrotic dysplasia, and cardiac defect. A cause and
effect relationship has not been established nor has the incidence
been shown to be higher than in the general population.
The Non-teratogenic Effects subsection has been revised:
Non-teratogenic Effects: There have been post-marketing reports of
fetal death when pregnant women received Lovenox Injection. Causality
for these cases has not been determined. Pregnant women receiving
anti-coagulants, including enoxaparin, are at increased risk for
bleeding. Hemorrhage can occur at any site and may lead to death of
mother and/or fetus. Pregnant women receiving enoxaparin should be
carefully monitored. Pregnant women and women of child-bearing
potential should be apprised of the potential hazard to the fetus and
the mother if enoxaparin is administered during pregnancy.
In a clinical study of pregnant women with prosthetic heart valves
given enoxaparin (l mg/kg bid) to reduce the risk of thromboembolism,
2 of 7 women developed clots resulting in blockage of the valve and
leading to maternal and fetal death. There are postmarketing reports
of prosthetic valve thrombosis in pregnant women with prosthetic heart
valves while receiving enoxaparin for thromboprophylaxis. These events
resulted in maternal death or surgical interventions. The use of
Lovenox Injection is not recommended for thromboprophylaxis in
pregnant women with prosthetic heart valves (see WARNINGS: Prosthetic
Heart Valves).?
http://www.fda.gov/medwatch/SAFETY/2002/lovenox.htm
?If the platelet count falls below 100,000/mm3, Lovenox Injection
should be discontinued.? Your daughter?s obstetrician is surely
monitoring your daughter?s platelet count on a regular basis, to avoid
getting thrombocytopenia (low platelet count).
?All pregnancies have a background risk of birth defects, loss, or
other adverse outcome regardless of drug exposure. The fetal risk
summary below describes mental abnormalities above background risk.
Fetal Risk Summary
Lovenox is not predicted to increase the risk of developmental
abnormalities. Lovenox does not cross the placenta, based on human and
animal studies, and shows no evidence of teratogenic effects or
fetotoxicity.
Clinical Considerations
It is not known if dose adjustment or monitoring of anti-Xa activity
of enoxaparin are necessary during pregnancy.
Pregnancy alone confers an increased risk for thromboembolism, that is
even higher for women with thromboembolic disease and certain high
risk pregnancy conditions. While not adequately studied, pregnant
women with mechanical prosthetic heart valves may be at even higher
risk for thrombosis?
?Human Data -There are no adequate and well-controlled studies in pregnant women.
A retrospective study reviewed the records of 604 women who used
enoxaparin during pregnancy. A total of 624 pregnancies resulted in
693 live births. There were 72 hemorrhagic events (11 serious)in 63
women. There were 14 cases of neonatal hemorrhage.Major congenital
anomalies in live births occurred at rates (2.5%)similar to background
rates.
There have been postmarketing reports of fetal death when pregnant
women received Lovenox Injection. Causality for these cases has not
been determined. Insufficient data, the underlying disease, and the
possibility of inadequate anticoagulation complicate the evaluation of
these cases.?
In reading this site, I am reassured that although there are few
reliable studies done in pregnant women, in looking at the record of
604 women, side effects of Lovenox are not extremely high. The only
dangers listed on several sites are bleeding. Careful monitoring of
your daughter should prevent this from happening. Watch for small red
spots that may appear anywhere on her skin, called hemangiomas and
petechiae which would appear before bruising. Call the doctor should
any bruising or petechiae appear on your daughter?s skin.
http://www.rxlist.com/cgi/generic3/lovenox_wcp.htm
This study came to the following conclusion:
?CONCLUSIONS: The incidence of adverse events reported could be
explained by the high risk profile of the study population. Overall,
this retrospective study suggests enoxaparin is well tolerated during
pregnancy.?
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11762651&dopt=Abstract
Another study:
?In the prophylactic group there were no fetal losses, thromboembolic
events or complications related to enoxaparin. In the therapeutic
group there were four first trimester miscarriages, a termination and
27 live births. Therapeutic enoxaparin prevented further
thromboembolism without complications. One woman was treated with
intermediate dose enoxaparin when she presented at 5 weeks? gestation
on warfarin and 7 weeks after a venous thromboembolism. She developed
a recurrent pulmonary embolus 3 weeks later and was subsequently
treated with therapeutic enoxaparin. In the therapeutic group the
enoxaparin dose/kg correlated poorly with anti-Xa levels, and dose
adjustments were made. Therapeutic mean (SD) trough and peak anti-Xa
levels were 0.33 U/mL (0.14) and 0.86 U/mL (0.24) in the first
trimester and 0.48 U/mL (0.19) and 0.84 U/mL (0.23) in the third
trimester.
Conclusions:
In the present series, prophylactic and therapeutic enoxaparin
treatment during pregnancy was effective and safe. Studies are
required to determine the optimal duration of treatment with
therapeutic enoxaparin following venous thromboembolism in pregnancy
and the clinical relevance of anti-Xa monitoring.?
http://www.ingentaconnect.com/content/bsc/ajo/2003/00000043/00000002/art00010
The following site should reassure you further:
?Can I use Lovenox for pregnant or nursing women?
Lovenox is in pregnancy category B meaning that studies in animals
showed no evidence of teratogenicity or fetotoxicity. Lactating
mothers should be cautioned when receiving Lovenox. Several small
studies have shown that the use of LMWH in pregnant women was safe.
However, there are no adequate and well controlled studies in this
patient population.?
http://www.aahcp.org/dvt/faqs.htm
?Once you accept the necessity for the use of Levonox during pregnancy
you will realize that the only alternative is the use of Heparin.
Levonox works better and is easier to take and to monitor. I have many
patients on Levonox during pregnancy for similar problems such as
yours. Multiple gestations are not a contradiction to its use. The
reason for the trepidations in the use of epidurals is with low
platelets. Levonox use during pregnancy will not cause undue anxiety
or too much thinning of your blood and you shoujld be able to carry to
term without fear of the clotting disorder. Of course you should
always work with a hematologist in conjunction with your obstetrician
or perinatologist.?
http://experts.about.com/q/1007/3438074.htm
?Do not take aspirin, ibuprofen (Motrin, Advil, Nuprin, and others),
ketoprofen (Orudis KT, Orudis, Oruvail), naproxen (Aleve, Naprosyn,
Anaprox, and others), indomethacin (Indocin), or any other
nonsteroidal anti-inflammatory medication without first talking to
your doctor. These medicines may lead to bleeding when taken with
enoxaparin. Ask your pharmacist or doctor before taking any
prescription or over-the-counter medication during treatment with
enoxaparin.?
http://www.drugs.com/MTM/enoxaparin.html
A more scientific paper on miscarriage and clotting factors.
http://www3.oup.co.uk/eshre/press-release/freepdf/170442.pdf
Your daughter?s obstetrician probably has experience using Lovenox
in high risk pregnancies. Ask her/him if this is so. S/he will also
determine how long your daughter should be on this therapy. It?s
possible she will need only during the first trimester, or depending
on her condition, she may need it most of the pregnancy, stopping
shortly before delivery to avoid excessive bleeding. Discuss the
possibility of bleeding should your daughter want a spinal or epidural
form of anesthesia, before she goes into labor. The doctor surely
discussed the risks with your daughter. Together, they probably
evaluated this personal decision the risks of Lovenox with the risks
of not taking it. Many women decide to take the small risk of
complications in order to have children.
Be sure the baby?s pediatrician is aware that your daughter has been
on Lovenox during her pregnancy, so the baby can be properly assessed
at birth. (Vitamin K, a clotting factor, is often given shortly after
birth to babies, to prevent bleeding)
Folgard
========
Folgard is a dietary supplement consisting of folic acid (folate)
and vitamins B6 and B12. Lack of folic acid in a pregnant woman can
cause neural tube defects in the fetus, manifested as spina bifida,
spinal cord defects, Down syndrome, and brain deformities. The doctor
can have blood drawn between the 16th and 18th week of pregnancy, for
an AFP to test for neural tube defects.
?Neural tube defects are quite rare. Out of 1,000 pregnant women, only
one or two will have a baby born with a neural tube defect. Neural
tube defects are birth defects in which the brain or part of the
spinal cord does not form normally, and may not be covered with skin
or bone. In the first weeks of pregnancy, when the fetus is less than
one inch long, the brain and spinal cord begin to form. They form from
a structure along the back of the fetus called the neural tube. The
top of the tube develops into the brain; the rest of the tube becomes
the spinal cord. Neural tube defects occur when the neural tube does
not close properly to form the brain or spinal cord. The exact causes
of neural tube defects are unknown, but heredity plays a part.?
http://www.fha.state.md.us/genetics/html/afp_tst.html
Folgard (Oral) Side Effects
Call your doctor right away if you notice any of these side effects:
· Allergic reaction: Itching or hives, swelling in your face or
hands, swelling or tingling in your mouth or throat, chest tightness,
trouble breathing.
· Unusual bleeding, bruising, or weakness If you notice these less
serious side effects, talk with your doctor:
· Feeling bloated or swollen
· Feeling unusually sleepy or tired
· Mild diarrhea
· Skin tingling, burning, or itching
http://www.healthdigest.org/Folgard-(Oral)_3621_PRO.php
http://www.talkmedical.com/medications/2596/Folgard-Rx-2-2
Women with MTHFR also have a difficult time metabolizing dietary folic
acid, and can benefit from Folgard.
http://www.thorne.com/altmedrev/fulltext/meth1-4.html
I hope this has answered your questions. If anything is unclear,
please not not rate this answer until you have requested an Answer
Clarification. This will allow me to assist your further, if possible.
Congratulation on being a grandma-to-be!
Sincerely, Crabcakes
Search Terms
miscarriage + MTHFR (methylene hydrofolate reductase)
Lovenox + miscarriage + pregnancy
enoxaparin sodium
Folgard |
