BACLOFEN
Drugs in Pregnancy and Lactation.
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Name: BACLOFEN
Class: Muscle Relaxant
Risk Factor: C
Fetal Risk Summary
Only two reports have been located that describe the use of the muscle relaxant, baclofen, in human pregnancy. Because of its specialized indication to control spasticity secondary to multiple sclerosis and other spinal cord diseases and injuries, its use in pregnancy is anticipated to be limited.
When baclofen doses 7–13 times the recommended human dose were administered to pregnant rats and rabbits, increased incidences of omphaloceles and incomplete sternebral ossification were observed in rat fetuses, and an increased incidence of unossified phalangeal nuclei of the fetal limbs was noted in rabbits (1). Shepard reviewed three studies involving rats, mice, and rabbits in which the drug was administered during organogenesis and all reported negative teratogenic findings (2). In contrast, a 1995 study in pregnant rats using 30 or 60 mg/kg on day 10 of gestation observed vertebral arch widening at the lower dose, similar to that produced by valproic acid in rats (3). The author concluded that baclofen could produce spina bifida or other neural tube defects in rats. Interestingly, the 60-mg/kg dose did not produce this effect, causing speculation that the dose caused a greater severity of neural tube defects, and thus a greater number of unrecorded early fetal deaths (3).
Two reports, involving three pregnancies, have been located that describe the use of baclofen in pregnant humans (4,5). A 29-year-old woman with quadriplegia due to an incomplete cervical C6-7 spinal cord lesion following discitis after discography was treated with a continuous intrathecal infusion of baclofen (1000 µg/24 hours) for 15 months to control her intractable spasticity (4). Conception occurred after ovulation stimulation with clomiphene. The baclofen dose was gradually increased to 1200 µg/24 hours to maintain control of her spasticity as the pregnancy progressed. Because of severe symptoms of autonomic dysfunction and loss of spasticity control (even at 1400 µg/24 hours), a cesarean section was conducted under epidural bupivacaine anesthesia in the 35th week of gestation. A 2040-g healthy female infant was delivered with Apgar scores of 9 and 10 (timing not specified).
A second case report, similar to the one above, was published in 2000 (5). A 38-year-old woman became pregnant after approximately 3.5 years of continuous intrathecal baclofen infusion to control severe spasticity resulting from a complete fifth cervical vertebra (C5)-level medular injury. Good control of her spasticity was obtained with intrathecal baclofen (140 mg/day) throughout her pregnancy. A healthy, 2155-g, male infant was delivered by cesarean section at 36 weeks' gestation with Apgar scores of 9 and 10 at one and five minutes, respectively. The birth weight, length (47 cm), and head circumference (33 cm) were appropriate for gestational age (5). No major or minor malformations were noted on physical and ultrasonographic examinations and the child was developing normally at 24 months of age. Three months after delivery of her first infant, the woman became pregnant a second time and again received continuous intrathecal baclofen (140 mg/day) throughout the gestation. A repeat cesarean section was performed at 34 weeks' gestation with delivery of another healthy, 2240-g, male infant with Apgar scores of 8 and 10 at one and five minutes, respectively. The weight, length (46 cm), and head circumference (32 cm) were appropriate for gestational age. No abnormalities were noted in the infant and he was developing normally at 12 months of age (5).
Breast Feeding Summary
In an animal study, the g-aminobutyric acid agonist, baclofen, was a potent inhibitor of suckling-induced prolactin release from the anterior pituitary (6). The drug had no effect on milk ejection. Because prolactin release is required to maintain lactation, the potential for decreased milk production with chronic use may exist. However, no human studies on this topic have been located.
Small amounts of baclofen are excreted into human milk. A 20-year-old woman with spastic paraplegia, who was 14 days postpartum, was given a single 20-mg (94 µmol) dose of baclofen (7). No mention was made as to whether her infant was nursing. Serum samples were drawn at 1, 3, 6, and 20 hours after the dose, and milk samples were obtained at 2, 4, 8, 14, 20, and 26 hours. The highest serum concentration measured, 1.419 µmol/L, occurred at 3 hours whereas the highest milk level, 0.608 µmol/L, was obtained at 4 hours. The total amount of drug recovered from the milk during the 26-hour sampling period was 22 µg (0.10 µ(mol), or about 0.1% of the mother's dose. The authors speculated that this amount would not lead to toxic levels in a nursing infant (7). The American Academy of Pediatrics considers baclofen to be compatible with breast feeding (8).
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References
- Product information. Lioresal. Geigy Pharmaceuticals, 1993.
- Shepard TH. Catalog of Teratogenic Agents. 6th ed. Baltimore, MD:Johns Hopkins University Press, 1989:66.
- Briner W. Muscimol- and baclofen-induced spina bifida in the rat. Med Sci Res 1995;24:639– 40.
- Delhaas EM, Verhagen J. Pregnancy in a quadriplegic patient treated with continuous intrathecal baclofen infusion to manage her severe spasticity. Case report. Paraplegia 1992;30:527–8.
- Munoz FC, Marco DG, Perez AV, Camacho MM. Pregnancy outcome in a woman exposed to continuous intrathecal baclofen infusion. Ann Pharmacother 2000;34:956.
- Lux VA, Somoza GM, Libertun C. Beta-(-4 chlorophenyl) GABA baclofen) inhibits prolactin and thyrotropin release by acting on the rat brain. Proc Soc Exp Biol Med 1986;183:358–62.
- Eriksson G, Swahn C-G. Concentrations of baclofen in serum and breast milk from a lactating woman. Scand J Clin Lab Invest 1981;41:185–7.
- Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 1994;93:137–50.
Q&A about Baclofen
Can a baclofen pump be installed in a 4-year old child who weights 23 kilograms and has severe spasticity as a result of cerebral palsy?
1. Have severe spasms that affect the arms, legs or both.
2. Have spasms that intefere with self-care or daily activities.
3. Have painful spasms
4. Have enough body mass (not necessarily weight) to support a pump and be at least 4 years old.
5. Have adequate strength in the neck and trunk.
6. Have had a good response to a trial of baclofen.
The infusion system itself consists of an implantable pump (6.6cm wide and 2.2cm thick), an intrathecal catheter and a computer. The pump runs on a 3-5 year lithium battery.
You will need to have your child evaluated to find out if he/she is a good candidate.
I've started taking Baclofen for suspected fibromyalgia. It makes me feel a little stoned, but hasn't helped the pain yet. Does it take a while to get into my system and are they're others out there who take this med. and is it successful for the treatment of fibro.
My wife is taking baclofen 10mg. She takes 1/2 tablet three times daily. I was wondering, what type of pain reliever can she take whenever she needs to? We forgot to ask the doctor about that. I checked online, and found out that Ibuprofen interacts with baclofen in a bad way, but I could not find anything about acetaminophen or aspirin or other types of pain relievers.
Here is what I found on Lexi-Comp a professional pharmacy database:
Summary Ibuprofen may enhance the adverse/toxic effect of Baclofen. Severity Moderate Reliability Rating Poor
Patient Management No action required.
Discussion Case report. A baclofen-stable patient (20 mg three times daily) experienced signs and symptoms of toxicity within 3 days of initiating ibuprofen therapy (600 mg three times daily).1 The cause of the observed events is unclear. Ibuprofen may have caused renal dysfunction which in turn may have reduced baclofen elimination. This is only report implicating such an interaction.
I searched two other databases, Clinical Pharmacology and Facts and Comparisons and it said that there were no interactions between the two.
I checked all three and not one of them came up with a drug-drug interaction between acetaminophen and baclofen. So if she is concerned about taking the ibuprofen have her take acetaminophen. If you still have concerns, I would contact your doctor.
Good Luck!!!
I have been unable to walk for 12 days, due to complete feet numbness. Have ms and must take another mri due to this. But tonight after taking the baclofen, maybe 20 minutes later, the numbness got much worse. I just figured it could be this.
What are some other common uses?
I really need them cause im in pain and i had them but they finished up but i don't have any prescription.
Please help the pain is killing me.
http://www.drugs.com/condition/muscle-sp...
However you will still need to see a Doc. Best of Luck
Looking for a better delivery system for valium other than by pill. Need to have a slower and more even release. Injection into the muscle works but not fesiable. An IV injection is too much too fast.
As an educated, active adult with Spastic Cerebral Palsy, I am planning the above procedure to improve my daily functioning. I have tried Botox, oral Baclofen, and had several orthopedic operations when I was a lot younger. Upon talking with various medical professionals, I had 3 options-orthopedic surgery again, selective dorsal rhizotomy-irreversible, and the baclofen pump. I would like to hear from others who have had this procedure done and can give me a better insight as to what to expect, opinions, results, etc. Any first-hand info would be very much appreciated!
I have MS and have actually talked to a Baclofen rep at a MS Exp and know someone with a pump although I haven't had one myself. (I've been on MAX doses of Baclofen - and have had botox for hemi-facial spasms- but my issues were only temporary)
From what I've been told - the pump is a life saver (In that it lets you function more normally). My only concern with it is tolerating the side effects of the baclofen. If you tolerated the side effects well.....I'd say go for it.
(if you do - make sure the pump does not run out of medication. I've heard that can be a nightmare.)
Goodluck!
~jifr!
