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I'm 5 wks and 4 days pregnant, is Tramadol safe?
I have my first OB appt this Tuesday but I have been taking my Tramadol as prescribed. I was told not to stop because it causes withdrawal. I learned that the hard way. What can I do? Is it safe to take my Tramadol while pregnant? Am I hurting my baby?
MEDICAL PROFESSIONAL
Dear SSgt_Best_Girl:
It is stated in the medication drug label that: "withdrawal symptoms may occur if tramadol (hydrochloride) is discontinued abruptly". Reference:http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ae7c54b1-b440-4cca-97e8-e5b825413d32#nlm34070-3
The withdrawals symptoms may include: anxiety, sweating, tremors, insomnia, etc. Thus, it is important to taper tramadol dosage down to avoid withdrawal symptoms. Please talk to your OBGYN regarding how to taper your tramadol dosage.
Tramadol is in the FDA Pregnancy Category C, which means there are no adequate and well-controlled studies in pregnant women. Its safety is not conclusive in human, but studies in animals have shown adverse effect on fetus. The benefit of using medications in Category C needs to outweigh the risks of taking it.
From tramadol manufacture medication label:
**************************************************************************************
"Pregnancy Category C
Tramadol has been shown to be embryotoxic and fetotoxic in mice, (120 mg/kg or 360 mg/m2), rats (≥25 mg/kg or 150 mg/m2) and rabbits (≥75 mg/kg or 900 mg/m2) at maternally toxic dosages, but was not teratogenic at these dose levels. These dosages on a mg/m2 basis are 1.4, ≥0.6, and ≥3.6 times the maximum daily human dosage (246 mg/m2) for mouse, rat and rabbit, respectively.
No drug-related teratogenic effects were observed in progeny of mice (up to 140 mg/kg or 420 mg/m2), rats (up to 80 mg/kg or 480 mg/m2) or rabbits (up to 300 mg/kg or 3600 mg/m2) treated with tramadol by various routes. Embryo and fetal toxicity consisted primarily of decreased fetal weights, skeletal ossification and increased supernumerary ribs at maternally toxic dose levels. Transient delays in developmental or behavioral parameters were also seen in pups from rat dams allowed to deliver. Embryo and fetal lethality were reported only in one rabbit study at 300 mg/kg (3600 mg/m2), a dose that would cause extreme maternal toxicity in the rabbit. The dosages listed for mouse, rat and rabbit are 1.7, 1.9 and 14.6 times the maximum daily human dosage (246 mg/m2), respectively.
Non-teratogenic Effects
Tramadol was evaluated in peri- and post-natal studies in rats. Progeny of dams receiving oral (gavage) dose levels of 50 mg/kg (300 mg/m2 or 1.2 times the maximum daily human tramadol dosage) or greater had decreased weights, and pup survival was decreased early in lactation at 80 mg/kg (480 mg/m2 or 1.9 times the maximum daily human dose).
There are no adequate and well-controlled studies in pregnant women. Tramadol hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonatal seizures, neonatal withdrawal syndrome, fetal death and still birth have been reported during post-marketing.
Labor and Delivery
Tramadol hydrochloride should not be used in pregnant women prior to or during labor unless the potential benefits outweigh the risks. Safe use in pregnancy has not been established. Chronic use during pregnancy may lead to physical dependence and post-partum withdrawal symptoms in the newborn (seeDRUG ABUSE AND DEPENDENCE). Tramadol has been shown to cross the placenta. The mean ratio of serum tramadol in the umbilical veins compared to maternal veins was 0.83 for 40 women given tramadol during labor.
The effect of tramadol hydrochloride, if any, on the later growth, development, and functional maturation of the child is unknown.
Nursing Mothers
Tramadol hydrochloride is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied. Following a single IV 100 mg dose of tramadol, the cumulative excretion in breast milk within 16 hours postdose was 100 mcg of tramadol (0.1% of the maternal dose) and 27 mcg of M1."
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ae7c54b1-b440-4cca-97e8-e5b825413d32#nlm34070-3
**************************************************************************************
Please share your concern and this information with your OBGYN regarding tramadol usage during pregnancy.
Tramadol is in the class of pain medications called opiate analgesics, similar to morphine. This class of medications works by changing the way the brain and nervous system respond to pain, but it has addiction potential. It is indicated to treat moderate to moderately severe pain.
What are you taking this medication for? Are there other safer alternatives for you to consider during pregnancy? If you are pregnant, especially the first 12 weeks, it is best to avoid any medicine that can bring potential harm to your baby, unless the benefits outweigh the risks. Medicines in the FDA's Pregnancy Category A and B are preferred.
It is also very important to follow-up with your OBGYN and pharmacist regarding what other medication(s) you are taking and/or if you have special medical conditions.
Good luck and take care of yourself and your baby!
For more information, please go to:
1. Tramadol - Medline Plus
http://www.nlm.nih.gov/medlineplus/druginfo/meds/a695011.html
2. Pain - Medline Plus
http://www.nlm.nih.gov/medlineplus/pain.html
3. Pregnancy - Womenshealth.gov
http://www.womenshealth.gov/pregnancy/
It is stated in the medication drug label that: "withdrawal symptoms may occur if tramadol (hydrochloride) is discontinued abruptly". Reference:http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ae7c54b1-b440-4cca-97e8-e5b825413d32#nlm34070-3
The withdrawals symptoms may include: anxiety, sweating, tremors, insomnia, etc. Thus, it is important to taper tramadol dosage down to avoid withdrawal symptoms. Please talk to your OBGYN regarding how to taper your tramadol dosage.
Tramadol is in the FDA Pregnancy Category C, which means there are no adequate and well-controlled studies in pregnant women. Its safety is not conclusive in human, but studies in animals have shown adverse effect on fetus. The benefit of using medications in Category C needs to outweigh the risks of taking it.
From tramadol manufacture medication label:
**************************************************************************************
"Pregnancy Category C
Tramadol has been shown to be embryotoxic and fetotoxic in mice, (120 mg/kg or 360 mg/m2), rats (≥25 mg/kg or 150 mg/m2) and rabbits (≥75 mg/kg or 900 mg/m2) at maternally toxic dosages, but was not teratogenic at these dose levels. These dosages on a mg/m2 basis are 1.4, ≥0.6, and ≥3.6 times the maximum daily human dosage (246 mg/m2) for mouse, rat and rabbit, respectively.
No drug-related teratogenic effects were observed in progeny of mice (up to 140 mg/kg or 420 mg/m2), rats (up to 80 mg/kg or 480 mg/m2) or rabbits (up to 300 mg/kg or 3600 mg/m2) treated with tramadol by various routes. Embryo and fetal toxicity consisted primarily of decreased fetal weights, skeletal ossification and increased supernumerary ribs at maternally toxic dose levels. Transient delays in developmental or behavioral parameters were also seen in pups from rat dams allowed to deliver. Embryo and fetal lethality were reported only in one rabbit study at 300 mg/kg (3600 mg/m2), a dose that would cause extreme maternal toxicity in the rabbit. The dosages listed for mouse, rat and rabbit are 1.7, 1.9 and 14.6 times the maximum daily human dosage (246 mg/m2), respectively.
Non-teratogenic Effects
Tramadol was evaluated in peri- and post-natal studies in rats. Progeny of dams receiving oral (gavage) dose levels of 50 mg/kg (300 mg/m2 or 1.2 times the maximum daily human tramadol dosage) or greater had decreased weights, and pup survival was decreased early in lactation at 80 mg/kg (480 mg/m2 or 1.9 times the maximum daily human dose).
There are no adequate and well-controlled studies in pregnant women. Tramadol hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonatal seizures, neonatal withdrawal syndrome, fetal death and still birth have been reported during post-marketing.
Labor and Delivery
Tramadol hydrochloride should not be used in pregnant women prior to or during labor unless the potential benefits outweigh the risks. Safe use in pregnancy has not been established. Chronic use during pregnancy may lead to physical dependence and post-partum withdrawal symptoms in the newborn (seeDRUG ABUSE AND DEPENDENCE). Tramadol has been shown to cross the placenta. The mean ratio of serum tramadol in the umbilical veins compared to maternal veins was 0.83 for 40 women given tramadol during labor.
The effect of tramadol hydrochloride, if any, on the later growth, development, and functional maturation of the child is unknown.
Nursing Mothers
Tramadol hydrochloride is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied. Following a single IV 100 mg dose of tramadol, the cumulative excretion in breast milk within 16 hours postdose was 100 mcg of tramadol (0.1% of the maternal dose) and 27 mcg of M1."
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ae7c54b1-b440-4cca-97e8-e5b825413d32#nlm34070-3
**************************************************************************************
Please share your concern and this information with your OBGYN regarding tramadol usage during pregnancy.
Tramadol is in the class of pain medications called opiate analgesics, similar to morphine. This class of medications works by changing the way the brain and nervous system respond to pain, but it has addiction potential. It is indicated to treat moderate to moderately severe pain.
What are you taking this medication for? Are there other safer alternatives for you to consider during pregnancy? If you are pregnant, especially the first 12 weeks, it is best to avoid any medicine that can bring potential harm to your baby, unless the benefits outweigh the risks. Medicines in the FDA's Pregnancy Category A and B are preferred.
It is also very important to follow-up with your OBGYN and pharmacist regarding what other medication(s) you are taking and/or if you have special medical conditions.
Good luck and take care of yourself and your baby!
For more information, please go to:
1. Tramadol - Medline Plus
http://www.nlm.nih.gov/medlineplus/druginfo/meds/a695011.html
2. Pain - Medline Plus
http://www.nlm.nih.gov/medlineplus/pain.html
3. Pregnancy - Womenshealth.gov
http://www.womenshealth.gov/pregnancy/
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