pregnancy

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rls mom

pregnancy

Postby rls mom » Thu Oct 28, 2004 11:26 pm

Has anyone found a drug that is safe to use during pregnancy? I currently take mirapex and my doctor has told me to stop it before becoming pregnant. Two months off the meds has been awful. I'm desperate!

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sardsy75
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Postby sardsy75 » Fri Oct 29, 2004 10:31 am

That question was top of my list at my last Neuro visit in August.

He put the answer in pretty simple terms, there are NO drugs for RLS that can be used safely during pregnancy. I had already heard that from my first neuro, so it just confirmed the inevitable ... getting pregnant ain't gonna be fun! I'm starting to look at it as another challenge to be conquered in my life; but one that i'm not quite ready to face, just yet.

The only things he DID say I could use if we decide to start a family are paracetamol and the like, massages, spa baths, etc; and that it would definitely not be an easy time. However, he did promise to be there and try to come up with a solution if things get too bad; but what that might be, even he's not sure about.

Work with your doc, don't push them away ... you're going to need him/her with you all the way.

There are a number of members here who have already been through this, so i'm sure they will be more than willing to lend an ear and some advice about what they found helpful.

My thoughts are with you! Stay strong!

Take care!
Nadia

My philosophy is simply this: Life is too short to be diplomatic. Your friends should not care what you do, or say; and for those who are not your friends ... their loss!!!

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sardsy75
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Stumbled Across Something

Postby sardsy75 » Sun Oct 31, 2004 3:23 am

OK, I’m putting this out there for the collective “brainiacks” in our group to ponder.

I'm currently researching the drugs used to treat RLS for the RLS Australia Website.

This morning I have been focusing on Bromocriptine Mesylate.

In the "precautions" section of my medication handbook it states:

Safe to use in Pregnancy (A); where (A) indicates that there is no proven direct or indirect harmful effects to the foetus.

I looked up the Australian Medication Regulatory Authority’s Site, http://www.tga.gov.au/docs/html/mip/medicine.htm#CNS and did a search on bromocriptine, and sure enough it came up with “A” again:

Category A
Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.


Just underneath bromocriptine was Cabergoline, with a rating B1:

Category B1
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have not shown evidence of an increased occurrence of fetal damage.


Well, this pricked my ears, as you can well imagine, so I've been doing a little ferreting about the web and have come up with some interesting information:

1) http://www.rxlist.com/cgi/generic3/brom ... ne_wcp.htm

Pregnancy

Category B: Administration of 10-30 mg/kg of bromocriptine to 2 strains of rats on days 6-15 post coitum (p.c.) as well as a single dose of 10 mg/kg on day 5 p.c. interfered with nidation. Three mg/kg given on days 6-15 were without effect on nidation, and did not produce any anomalies. In animals treated from day 8-15 p.c., i.e., after implantation, 30 mg/kg produced increased prenatal mortality in the form of increased incidence of embryonic resorption. One anomaly, aplasia of spinal vertebrae and ribs, was found in the group of 262 fetuses derived from the dams treated with 30 mg/kg bromocriptine. No fetotoxic effects were found in offspring of dams treated during the pre- or post-natal period.

Two studies were conducted in rabbits (2 strains) to determine the potential to interfere with nidation. Dose levels of 100 or 300 mg/kg/day from day 1 to day 6 p.c. did not adversely affect nidation. The high dose was approximately 63 times the maximum human dose administered in controlled clinical trials (100 mg/day), based on body surface area. In New Zealand white rabbits some embryo mortality occurred at 300 mg/kg which was a reflection of overt maternal toxicity. Three studies were conducted in 2 strains of rabbits to determine the teratological potential of bromocriptine at dose levels of 3, 10, 30, 100, and 300 mg/kg given from day 6 to day 18 p.c. in 2 studies with the Yellow-silver. strain, cleft palate was found in 3 and 2 fetuses at maternally toxic doses of 100 and 300 mg/kg, respectively. One control fetus also exhibited this anomaly. In the third study conducted with New Zealand white rabbits using an identical protocol, no cleft palates were produced.

No teratological or embryo-toxic effects of bromocriptine were produced in any of 6 offspring from 6 monkeys at a dose level of 2 mg/kg.

Information concerning 1276 pregnancies in women taking bromocriptine has been collected. In the majority of cases, bromocriptine was discontinued within 8 weeks into pregnancy (mean 28.7 days), however, 8 patients received the drug continuously throughout pregnancy. The mean daily dose for all patients was 5.8 mg (range 1-40 mg).

Of these 1276 pregnancies, there were 1088 full term deliveries (4 stillborn), 145 spontaneous abortions (11.4%), and 28 induced abortions (2.2%). Moreover, 12 extrauterine gravidities and 3 hydatidiform moles (twice in the same patient) caused early termination of pregnancy. These data compare favorably with the abortion rate (11%-25%) cited for pregnancies induced by clomiphene citrate, menopausal gonadotropin, and chorionic gonadotropin.

Although spontaneous abortions often go unreported, especially prior to 20 weeks of gestation, their frequency has been estimated to be 15%. The incidence of birth defects in the population at large ranges from 2%-4.5%. The incidence in 1109 live births from patients receiving bromocriptine is 3.3%.
There is no suggestion that bromocriptine contributed to the type or incidence of birth defects in this group of infants.


2) http://www.emedicine.com/med/topic3264.htm

Dopamine agonists and fetal development

In principle, fetal exposure to dopamine should be limited. Accordingly, when patients are started on therapy for hyperprolactinemia, mechanical contraception can be advised for the first 2-3 cycles so that an intermenstrual period can be established. By doing this, the woman will know when she has missed a period when unprotected intercourse is resumed. As soon as this occurs, a pregnancy test can be obtained and bromocriptine stopped. This approach limits dopamine agonist exposure to a maximum of 3-4 weeks.

Bromocriptine has been shown in more than 6000 pregnancies to not increase the incidence of spontaneous abortions, trophoblastic disease, multiple pregnancies, or congenital malformations. In 2 studies in which bromocriptine was given before elective therapeutic abortions at 6-9 weeks, no effects were seen on estriol, estradiol, progesterone, testosterone, dehydroxyepiandrosterone, dihydroxy epiandrosterone sulfate, androstenedione, cortisol, and human placental lactogen levels. Maternal and fetal PRL levels were suppressed.

Follow-up of children exposed to bromocriptine during early pregnancy has also not demonstrated any adverse effects up to age 9 years. In approximately 100 women who took bromocriptine during weeks 20-41 of gestation, only 2 abnormalities (one talipes and one undescended testicle) were noted. The incidence is comparable to (or even less than) that of the normal population.

Data on the safety of pergolide during pregnancy are too limited to recommend its use. Cabergoline is a newer dopamine agonist that can be administered in a convenient once-a-week dosing schedule. It is particularly useful in patients who cannot tolerate bromocriptine because of its adverse effects. Outcome data available on 265 pregnancies in which cabergoline was administered to facilitate ovulation do not show increased risks of preterm ectopic or multiple birth deliveries or malformations.

Based on this, one may be reasonably certain that termination of the pregnancy is not necessary if a patient inadvertently becomes pregnant while taking cabergoline. However, until the safety of cabergoline is clearly established, bromocriptine should still be considered the therapy of choice if pregnancy is the desired outcome.


3) http://www.pituitary.org.uk/newsletter/ ... atters.htm

Your doctor will probably ask you to stop taking bromocriptine or quinagolide as soon as a pregnancy is confirmed (see ME letter). This is on the general principle that all drug treatment should be reduced to a minimum during pregnancy. Many thousands of 'bromocriptine babies' have now been born; there has been no increased incidence of malformation and the children have developed normally (see MP and LJ letters). Furthermore, the pregnancies have not been associated with an increased miscarriage rate. The same is true for quinagolide but the number of pregnancies is much lower because it's a newer drug (176 pregnancies up until 1996).

The situation is slightly different for cabergoline because it is such a long-acting drug (and therefore stays in the body for a few weeks after it's stopped), and also newly introduced. Your specialist will probably recommend you stop treatment one month before attempting to conceive. If you have been on the medicine for several months, normal egg-releasing cycles can persist for 3-6 months after stopping treatment. Having said this, as of early 1997, 277 pregnancies have been reported in women taking cabergoline at the time of conception. These pregnancies seem to have been just as successful as for bromocriptine and quinagolide so it's likely that the 'one month rule' will be withdrawn eventually, provided this early success is maintained.


4) http://www.infoparkinson.org/En/Contenu ... matern.asp

Pregnancy and Parkinson’s disease

The decision to have a child is always of great importance, and all the more so when you has a progressive disease. Ten-to-twenty percent of people with Parkinson’s disease will have their first symptoms before age 50, which can lead some women to reconsider their desire to have a child. It is normal to harbour some concerns. The main fears are linked to the effect of the medications on the fetus, of course, but also the impact of the pregnancy on the progress and course of the disease.
Most studies on animals have been unable to show with certainty that levodopa has a negative effect on the embryo. During laboratory experiments, the medication is always administered in association with a decarboxylase inhibitor (carbidopa or benzyrazide), which are agents associated with visceral and skeletal anomalies in study animals. However, in humans, none of these inhibitors appear to cross the placental barrier.

In addition, dopaminergic agonists bromocriptine, pergolide and lisuride do not appear to be harmful for animal fetuses. However, two medications are of greater concern, namely amantadine, marketed as Symmetrel®, and selegiline, also known as Eldepryl®. It has been shown that amantadine is teratogenic, i.e. toxic, for rats and their embryos. As for selegiline, its use in rats triggered biochemical disturbances in the brain, behavioural disturbances and convulsions. Lastly, no data exists on the safety of anticholinergics (Kemadrin, Artane).

Clinical experiments

The results of clinical experiments reported in the literature highlight the following points:

• Treatment with levodopa has triggered no complications during pregnancy and delivery for mothers, and no malformations or health problems in babies
• The use of agonists has also proven to be safe for the mother and has caused no specific problems in the child
• Five cases of major congenital malformations have been observed out of a total of 51 newborns exposed to amantadine during the first trimester
• No precise data is available concerning the impact of antiparkinsonian agents on breastfeeding. However, researchers have shown that the usual doses of dopaminergic agonists suppress lactation. The question remains as to whether levodopa and selegiline are present in maternal milk
• Amantadine has been shown to be present in small quantities in maternal milk, although no adverse event has been reported in the breastfed children

Other studies report that the neurological conditions of some women with Parkinson’s disease had deteriorated during or after pregnancy. Is there a direct link with the disease? Other factors may be involved, according to one theory on this subject. The significant metabolic changes and hormonal imbalances associated with pregnancy, especially the decrease in estrogen postpartum, are factors which may contribute to the changing neurological picture. This imbalance may lead to an upward adjustment of the medication.

Therefore,

• Pregnant women treated with levodopa (Sinemet®, Prolopa®) or a dopaminergic agonist (Mirapex®, Requip®, Permax®, Parlodel®) may continue their treatment during pregnancy
• The use of amantadine (Symmetrel®) and selegiline (Eldepryl®) is not recommended
• As the effect of antiparkinsonian agents on breastfeeding is not well documented, it is preferable, at this stage, to consider commercial milk formulas a better choice for feeding the baby

Having a child is one of the most wonderful of human achievements. However, in some circumstances, such as having a degenerative disease, it requires very careful reflection. It is normal to think about the mother’s health, as well as that of the unborn child. Persistent questions and concerns about a possible pregnancy are completely legitimate. In sharing with the care and medical team their desire to start a family, the prospective parents can get all the information available on pregnancy and Parkinson’s disease.


I can understand a doctor’s/neurologist’s hesitation at using any drugs during pregnancy for anyone suffering a mild, or even moderate form of RLS, but as someone who has a severe case of it, if we work together as a team (me, hubby, GP, OBGYN & Neuro, etc) the thought of not having to go through such excruciating RLS symptoms for the entire period gives me a new hope.

Although I’m far from being “clucky” right at this moment, I am thinking more and more about starting a family, sooner rather than later.

I have an appointment with a new (third) neurologist in three weeks time, so this topic will definitely be at the top of my list.

Any thoughts or comments from our more esteemed medical members of the group (as well as everyone else, of course!) would be more than welcome!
Nadia



My philosophy is simply this: Life is too short to be diplomatic. Your friends should not care what you do, or say; and for those who are not your friends ... their loss!!!

Twitchy Canadian
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Location: Ontario, Canada

Postby Twitchy Canadian » Thu Nov 11, 2004 2:35 am

hey Nadia.....excellent post! Very helpful and informative. :D One thing puzzles me tho:
Pregnant women treated with levodopa (Sinemet®, Prolopa®) or a dopaminergic agonist (Mirapex®, Requip®, Permax®, Parlodel®) may continue their treatment during pregnancy

I am (was) on Mirapex until 3 days ago. I had an appointment with my GP on Monday and again he told me to get off Mirapex (I weaned myself of Clonezpam a few weeks ago) He told me that Mirapex stayed in the system for only a 24-48 hr period, so I was safe to take it until a few days before conception. He made sure I would too, since he only gave me a prescription for 10 days. I decided to try to stop immediately (just to see if I could do it) That first night was a living he**, but 2 nights later my symptoms, altho still here, are relatively mild and certainly tolerable.
From everything I've read and been told so far, Mirapex is a class 'C' drug and a definate no-no during pregnancy. This article you quoted from is dated Aug 2003.....and from a Canadian source as well....are some docs (mine included) missing the boat here? :?
I'm also curious to know if there is anyone else out there who stopped their meds for whatever reason and their symptoms lessened.....very weird.....
Twitchy Canadian

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