AMITRIPTYLINE
Drugs in Pregnancy and Lactation.|
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Name: AMITRIPTYLINE
Class: Antidepressant
Risk Factor: CM
Fetal Risk Summary
Two reviews found reports of amitriptyline-induced teratogenicity in animals: encephaloceles and bent tails in hamsters (1) and skeletal malformations in rats (2). However, reproduction studies conducted by the manufacturer in mice, rats, or rabbits with oral doses of 2 to 40 mg/kg/day (up to 13 times the maximum recommended human dose [MRHD]) revealed no evidence of teratogenicity (3). The manufacturer does cite the teratogenicity of amitriptyline in mice, hamsters, rats, and rabbits when higher doses were used (3).
The manufacturer states that amitriptyline crosses the placenta (3). The relatively low molecular weight (about 314) is consistent with this finding.
In humans, limb reduction anomalies have been reported with amitriptyline (4,5). However, analysis of 522,630 births, 86 with 1st trimester exposure to amitriptyline, did not confirm an association with this defect (6,7,8,9,10,11,12 and 13). Reported malformations other than limb reduction defects after therapeutic dosing include the following (8,12,13 and 14):
Micrognathia, anomalous right mandible, left pes equinovarus (1 case)
Swelling of hands and feet (1 case)
Hypospadias (1 case)
Bilateral anophthalmia (1 case)
A case of maternal suicide attempt with a combination of amitriptyline (725 mg) and perphenazine (58 mg) at 8 days' gestation was described in a 1980 abstract (15). An infant was eventually delivered with multiple congenital defects. The abnormalities included microcephaly, “cotton-like” hair with pronounced shedding, cleft palate, micrognathia, ambiguous genitalia, foot deformities, and undetectable dermal ridges (15).
Thanatophoric dwarfism was found in a stillborn infant exposed throughout gestation to amitriptyline (>150 mg/day), phenytoin (200 mg/day), and phenobarbital (300 mg/day) (16). The cause of the malformation could not be determined, but both drug and genetic etiologies were considered.
In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 467 newborns had been exposed to amitriptyline during the 1st trimester (F. Rosa, personal communication, FDA, 1993). A total of 25 (5.4%) major birth defects were observed (20 expected). Specific data were available for six defect categories, including (observed/expected) 6/5 cardiovascular defects, 0/1 oral clefts, 0/0 spina bifida, 2/1 polydactyly, 2/1 limb reduction defects, and 1/1 hypospadias. These data do not support an association between the drug and the defects.
Neonatal withdrawal after in utero exposure to other antidepressants (see Imipramine), but not with amitriptyline, has been reported. However, the potential for this complication exists because of the close similarity among these compounds. Urinary retention in the neonate has been associated with maternal use of nortriptyline, an amitriptyline metabolite (see Nortriptyline) (17).
In summary, although occasional reports have associated the therapeutic use of amitriptyline with congenital malformations, the bulk of the evidence indicates these widely used drugs are relatively safe during pregnancy. The single case of gross overdose is suggestive of an association between amitriptyline, perphenazine, or both, and malformations, but without confirming evidence no conclusions can be determined. Because of the experience with tricyclic antidepressants, one review recommended they were preferred during gestation over other antidepressants (2).
Breast Feeding Summary
Amitriptyline and its active metabolite, nortriptyline, are excreted into breast milk (18,19 and 20). A recent study has measured the amount of a second active metabolite, E-10-hydroxynortriptyline, in milk (21).
Serum and milk concentrations of amitriptyline in one patient were 0.14 and 0.15 µg/mL, respectively, a milk:plasma ratio of 1.0 (18). No drug was detected in the infantís serum. In another patient, it was estimated that the baby received about 1% of the mother's dose (20). No clinical signs of drug activity were observed in the infant.
In the third study, the mother was treated with 175 mg/day of amitriptyline (21). Milk and maternal serum samples were analyzed for active drug and active metabolites on postpartum days 1–26. Amitriptyline serum levels ranged from 24 ng/mL (day 1) to 71 ng/mL (days 3–26), while those in the milk ranged from 24 ng/mL (day 1) to only 54% of the serum levels on days 2–26. Nortriptyline serum levels ranged from 17 ng/mL (day 1) to 87 ng/mL (day 26) with milk levels 74% of those in the serum. Mean concentration of the second metabolite, E-10-hydroxynortriptyline, was 127 ng/mL (days 1–26) in the serum and 70% of that in the milk. The total dose (parent drug plus metabolites) consumed by the male infant on day 26 was estimated to be 35 µg/kg (80 times lower than the mother's dose) (21). None of the compounds were detected in the nursing infant's serum on day 26 and no adverse effects, including sedation, were observed in him.
Although levels of amitriptyline and its metabolite have not been detected in infant serum, the effects of exposure to small amounts in the milk are not known (18,19 and 20,22). The American Academy of Pediatrics classifies amitriptyline as a drug whose effect on the nursing infant is unknown but may be of concern (23).
References
- Shepard TH. Catalog of Teratogenic Agents. 6th ed. Baltimore, MD:Johns Hopkins University Press, 1989:44–5.
- Elia J, Katz IR, Simpson GM. Teratogenicity of psychotherapeutic medications. Psychopharmacol Bull 1987;23:531–86.
- Product information. Elavil. AstraZeneca, 2000.
- McBride WG. Limb deformities associated with iminodibenzyl hydrochloride. Med J Aust 1972;1:492.
- Freeman R. Limb deformities: possible association with drugs. Med J Aust 1972;1:606.
- Australian Drug Evaluation Committee. Tricyclic antidepressants and limb reduction deformities. Med J Aust 1973;1:768–9.
- Heinonen OP, Slone D, Shapiro S. Birth Defects and Drugs in Pregnancy. Littleton, MA:Publishing Sciences Group, 1977:336–7.
- Idanpaan-Heikkila J, Saxen L. Possible teratogenicity of imipramine/chloropyramine. Lancet 1973;2:282–3.
- Rachelefsky GS, Glynt JW, Ebbin AJ, Wilson MG. Possible teratogenicity of tricyclic antidepressants. Lancet 1972;1:838.
- Banister P, Dafoe C, Smith ESO, Miller J. Possible teratogenicity of tricyclic antidepressants. Lancet 1972;1:838–9.
- Scanlon FJ. Use of antidepressant drugs during the first trimester. Med J Aust 1969;2:1077.
- Crombie DL, Pinsent R, Fleming D. Imipramine in pregnancy. Br Med J 1972;1:745.
- Kuenssberg EV, Knox JDE. Imipramine in pregnancy. Br Med J 1972;2:292.
- Golden SM, Perman KI. Bilateral clinical anophthalmia: drugs as potential factors. South Med J 1980;73:1404–7.
- Wertelecki W, Purvis-Smith SG, Blackburn WR. Amitriptyline/perphenazine maternal overdose and birth defects (abstract). Teratology 1980;21:74A.
- Rafla NM, Meehan FP. Thanatophoric dwarfism: drugs and antenatal diagnosis. A case report. Eur J Obstet Gynecol Reprod Biol 1990;38:161–5.
- Shearer WT, Schreiner RL, Marshall RE. Urinary retention in a neonate secondary to maternal ingestion of nortriptyline. J Pediatr 1972;81:570–2.
- Bader TF, Newman K. Amitriptyline in human breast milk and the nursing infants serum. Am J Psychiatry 1980;137;855–6.
- Wilson JT, Brown D, Cherek DR, Dailey JW, Hilman B, Jobe PC, Manno BR, Manno JE, Redetzki HM, Stewart JJ. Drug excretion in human breast milk. Principles, pharmacokinetics and projected consequences. Clin Pharmacokinet 1980;5:1–66.
- Brixen-Rasmussen L, Halgrener J, Jorgensen A. Amitriptyline and nortriptyline excretion in human breast milk. Psychopharmacology (Berlin) 1982;76:94–5.
- Breyer-Pfaff U, Nill K, Entenmann A, Gaertner HJ. Secretion of amitriptyline and metabolites into breast milk. Am J Psychiatry 1995;152:812–3.
- Erickson SH, Smith GH, Heidrich F. Tricyclics and breast feeding. Am J Psychiatry 1979;136:1483.
- 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 Amitriptyline
I've been given amitriptyline tablets for severe headaches/neuralgia but they don't seem to relieve the pain any.Has anyone ever been prescribed these and did they eventually work?
My father in law, who is 78 years old, recently expressed discomfort saying it felt like his dose of Amitriptyline was stuck deep in his throat. The next day, he lost his voice, and his throat was very sore (burning sensation). He also started spitting up and coughing up black stuff.
My mother in law took him to GI doctor (they didn't tell the doctor about the pill, just the black stuff) who scheduled a procedure to look at his throat, esophagus and stomach.
When complete, the doctor said that there was no sign of cancer and saw a healing ulcer in his stomach.
Now, my mother in law is wondering if maybe the black stuff was old dried blood from a burn in my father in law's esophagus.
Just wondering -- sounds far fetched to me.
Amitriptyline is the generic of Elavil.
My Steve committed suicide last December 16, and I'm still not over it. Maybe I never will be, in the sense of filling that hole left in my life. I cannot be a party to assisting suicide.
I desperately need to know if the combination of amitriptyline and escitaloprame can cause another to lose control, become aggressive and confused. What are affects and side affects of these drugs individually and combined together.
For effects of them together, you should ask your doctor - preferably a psychiatrist who has experience prescribing these drugs. Or, ask your pharmacist - they might not know the answer, but can tell you where to look. You can also go to scientific websites like www.medscape.com or www.pubmed.gov.
To be honest, you may not get the info you are looking for from these studies. They can be confusing and I don't know how many studies have specifically researched the combination you are asking for. But do the research, and you might come up with something.
Good luck. Sorry if this wasn't as helpful as you hoped.
Taking Amitriptyline and I just now noticed this side effect maybe?, on the side of the bottle. It says "You should avoid prolonged or excessive exposure to the direct and/or artificial sunlight when taking this medicine."
What exactly does that mean? And why should I avoid sunlight when taking this medicine?
I started taking amitriptyline a while back for nerve pain, it apparently doubles an anti-depressant and about a month after i started it i started sweating, a lot. i know sweating is a side effect of the drug, but i sweat when i go to do anything and it doesnt seem normal cuz im used to barely sweating ever. just wondering if neone else has experienced the same thing or if my symptom is just severe.
I just had 30 Mgs of it and i already have a headache and are a little dizzy. Just wondering if that was too much of a dose or too little.
Please answer me my head hurts! I have migraine. Im 16.
I drank 1 Tylenol 500mg then 4 hours later I drank 1 more, and now its been 11 hours since I've drank Tylenol. So is it okay to drink Amitriptyline now? Thanks.
I will choose best answer as soon as I can.
Ya 12 years, for headaches.I've been having side effects for years now and recently scary side effects. I take 100MG a day. Since I started taking them I've gotten these tiny red spots all over my body and they keep coming. The scary effects are anxiety, tingling around lips and fingers. My vision goes weird like I'm in a dream. I get light headed and I can't think right. Simple things I don't know. So I get scared and panic. I believe that all these symptoms are from the Amitriptyline. So I want off. Will it take longer like some of you?
I've only had one glass of white wine and already I feel woozy
Drink one more glass and see how you feel then. Some people can drink on anti-depressants with out any side effects. Some people can't and from there, there is a variety of unpleasant yet not life threatening things that I've seen occur.
You can try it out, JUST MAKE SURE YOU DON'T OVER DO IT!