TRANEXAMIC ACID

Drugs in Pregnancy and Lactation.

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Name: TRANEXAMIC ACID
Class: Hemostatic
Risk Factor:    BM

Fetal Risk Summary

This hemostatic agent, a competitive inhibitor of plasminogen activation, is used to reduce or prevent hemorrhage in hemophilia and in other bleeding disorders. The drug blocks the action of plasminogen activators (e.g., tissue plasminogen activator [alteplase; t-PA], streptokinase, and urokinase) by inhibiting the conversion of plasminogen to plasmin. No adverse fetal effects were observed in reproductive toxicity testing in mice, rats, and rabbits (1, 2). Both Schardein (3) and Shepard (4) cited a 1971 study in which doses up to 1500 mg/kg/day were given to mice and rats during organogenesis without causing adverse fetal effects.

Tranexamic acid crosses the human placenta to the fetus (5). Twelve women were given an IV dose of 10 mg/kg just before cesarean section. Cord serum and maternal blood samples were drawn immediately following delivery, a mean of 13 minutes after the dose of tranexamic acid. The mean drug concentrations in the cord and maternal serum were 19 µg/mL (range <4–31 µg/mL) and 26 µg/mL (range 10–53 µg/mL), respectively, a ratio of 0.7.

Twelve women with vaginal bleeding between 24 and 36 weeks' gestation were treated with 7-day courses of tranexamic acid, 1 g orally every 8 hours (6). Additional courses were given if bleeding continued (number of patients with repeat courses not specified). Four women underwent cesarean section (placenta previa in three, breech in one) and the remainder had vaginal deliveries. One of the newborns was delivered at 30 weeks' gestation, but the gestational ages of the other newborns were not specified. All of the newborns were alive and well. Two of the mothers were receiving treatment at the time of delivery, and the drug concentrations in the cord blood were 9 and 12 µg/mL.

A pregnant woman with fibrinolysis was treated with tranexamic acid and fibrinogen for 64 days until spontaneous delivery of a normal 1400-g girl at 30 weeks' gestation (7). No adverse fetal or newborn effects attributable to the drug were reported. Tranexamic acid was used in a woman with abruptio placentae during her third pregnancy (8). She had a history of two previous pregnancy losses because of the disorder. Treatment with tranexamic acid (1 g IV every 4 hours for 3 days, then 1 g orally 4 times daily) was begun at 26 weeks' gestation and continued until 33 weeks' gestation, at which time a cesarean section was performed because of the risk of heavier bleeding. A healthy 1430 g male infant was delivered.

The use of tranexamic acid in a woman with Glanzmann's thrombasthenia disease was described in an abstract published in 1981 (9). Treatment was started at 24 weeks' gestation and continued until spontaneous delivery at 42 weeks' gestation of a healthy boy. A study published in 1980 described the use of tranexamic acid in 73 consecutive cases of abruptio placentae, 6 of which were treated for 1–12 weeks (10). Six (8.2%) of the newborns were either stillbirths (N=4) or died shortly after delivery (N=2), a markedly reduced mortality rate compared with the expected 33%–37% at that time (10). None of the deaths were attributed to the drug. No cases of increased hemorrhage, thromboses, or maternal deaths were observed.

Tranexamic acid (4 g/day) was used in a 21-year-old primigravida at 26 weeks' gestation for the treatment of vaginal bleeding (11). She also received terbutaline and betamethasone for premature labor. Tranexamic acid was administered as a single dose on admission, and 6 days later a 10-day course was initiated for continued bleeding. Acute massive pulmonary embolism occurred at the termination of tranexamic acid, and following 2–3 days of treatment with heparin and streptokinase, a preterm 1140-g male infant was spontaneously delivered. No adverse effects in the fetus or newborn attributable to the drug therapy were noted.

A retrospective study published in 1993 examined the question of whether tranexamic acid was thrombogenic when administered during pregnancy (12). Between 1979–1988 in Sweden, among pregnant women with various bleeding disorders, 256 had been treated with tranexamic acid (mean duration 46 days), whereas 1,846 had not been treated (controls). Two patients (0.78%) in the treated group had pulmonary embolism compared with 4 (0.22%) (3 deep vein thromboses, 1 pulmonary embolism) (odds ratio 3.6, 95% confidence limits 0.7–17.8) in the control group. In the subgroups of those patients who were delivered by cesarean section (168 treated, 439 controls), the rates of thromboembolism were 1 (0.60%) and 4 (0.91%) (odds ratio 0.65, 95% confidence limits 0.1–5.8), respectively. Thus, no evidence was found indicating that the use of tranexamic acid during gestation was thrombogenic. Although the purpose of this study did not include examining the effects of the therapy on the fetus or newborn, the authors concluded that in the absence of a thrombogenic risk, there was no reason to change the indications for its use during pregnancy.

In summary, no adverse effects attributable to use of tranexamic acid during pregnancy, either in animals or humans, have been reported in the fetus or newborn. The drug crosses the placenta to the fetus, but its reported lack of effect on plasminogen activator activity in the vascular wall (10,12) (versus its known effect in the peripheral circulation) may protect the fetus and newborn from potential thromboembolic complications.

Breast Feeding Summary

Tranexamic acid is excreted into human milk. One hour after the last dose following a 2-day treatment course in lactating women, the milk concentration of the agent was 1% of the peak serum concentration (13). In adults, approximately 30%–50% of an oral dose is absorbed (1). The amount a nursing infant would absorb is unknown, as is the effect of the small amount of drug present in milk.

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References

  1. Product information. Cyklokapron. Pharmacia, 1996.
  2. Onnis A, Grella P, Lewis PJ. The Biochemical Effects of Drugs in Pregnancy. Volume 1. Chichester, England: Ellis Horwood, 1984:385.
  3. Schardein JL. Chemically Induced Birth Defects. 2nd ed. New York, NY: Marcel Dekker, 1993:107.
  4. Shepard TH. Catalog of Teratogenic Agents. 8th ed. Baltimore, MD: Johns Hopkins University Press, 1995:420.
  5. Kullander S, Nilsson IM. Human placental transfer of an antifibrinolytic agent (AMCA). Acta Obstet Gynecol Scand 1970;49:241–2.
  6. Walzman M, Bonnar J. Effects of tranexamic acid on the coagulation and fibrinolytic systems in pregnancy complicated by placental bleeding. Arch Toxicol 1982;Suppl 5:214–20.
  7. Storm O, Weber J. Prolonged treatment with tranexamic acid (Cyklokapron) during pregnancy. Ugeskr Laeg 1976;138:1781–2.
  8. Ästedt B, Nilsson IM. Recurrent abruptio placentae treated with the fibrinolytic inhibitor tranexamic acid. Br Med J 1978;1:756–7.
  9. Sundqvist S-B, Nilsson IM, Svanberg L, Cronberg S. Glanzmann's thrombasthenia: pregnancy and parturition (abstract). Thromb Haemost 1981;46:225.
  10. Svanberg L, Ästedt B, Nilsson IM. Abruptio placentae—treatment with the fibrinolytic inhibitor tranexamic acid. Acta Obstet Gynecol Scand 1980;59:127–30.
  11. Fagher B, Ahlgren M, Ästedt B. Acute massive pulmonary embolism treated with streptokinase during labor and the early puerperium. Acta Obstet Gynecol Scand 1990;69:659–62.
  12. Lindoff C, Rybo G, Ästedt B. Treatment with tranexamic acid during pregnancy and the risk of thrombo-embolic complications. Thromb Haemost 1993;70:238–40.
  13. Eriksson O, Kjellman H, Nilsson L. Tranexamic acid in human milk after oral administration of Cyklokapron to lactating women. Data on file, KabiVitrum AB, Stockholm, Sweden. (Data supplied by R.G. Leonardi, Ph.D., KabiVitrum, 1987).

Index

Q&A about Tranexamic Acid

sue
tranexamic acid?
can i take tranexamic acid for just one day?
dan.free...
This is a serious medication, it can be highly useful to stop bleeding, but it does carry risks see

http://www.medsafe.govt.nz/profs/PUartic...

You should only rely on proper medical advice on this one
aseret
Is tranexamic acid effective in reducing bleeding after dental extraction on a healthy patient?
Gauri K
Yes it has been proven that Traxenamic acid is quite effective in arresting bleeding after dental extraction. In normal patients as well as hemophiliacs.

Other agents equally effective are: Gelfoam, Surgicel, Oxycel, Fibrin glue, and adrenaline pack.

If a patient reports secondary bleeding after leaving the clinic, one can ask him to bite on a folded tea bag, which contains tannic acid which precipitates proteins and causes clot formation. That is until s/he can see you in your clinic again.
Emma T
Where can i get Tranexamic acid?
Is it a perscription drug or can I get it at a drugstore?
Stephani...
Tranexamic acid (commonly marketed as Cyklokapron in the U.S. and as Transamin in Asia) is often prescribed for excessive bleeding. It is an antifibrinolytic that competitively inhibits the activation of plasminogen to plasmin, a molecule responsible for the degradation of fibrin. Fibrin is the basic framework for the formation of a blood clot in hemostasis. It has roughly 8 times the antifibrinolytic activity of an older analogue, ε-aminoacaproic acid.

If you go to a natures sunshine website or call them directly they have a product called blood build that helps the fibrin in the blood. It helped me do exactly what this drug says it does. Call a distributor to find out what product is best for you.
Pepsi Galore!
Tranexamic acid+ Mefenamic acid?
I have bad problems with my periods.. They are very infrequant and i have very heavy bleeding and severe pains and vomitting. i was wondering can you take Tranexamic acid and mefenamic acid together? the mefenamic helps with the pain abit but the tranexamic acid is to help with the flow... i see no problem.... any help greatly appreciated!!
MissA
This is a toughie to answer. Most likely it's safe... the combination of the two is marketed under the brand name "Trenaxa MF". And assuming the same doctor prescribed both meds, and knows your medical history? Yeah, you should be okay.

OTOH if you got them from two different sources and aren't sure of safe dosages, call up your doc or local pharmacist. They'll be able to give you an answer for your specific case.
Abbiie
Does Tranexamic Acid Really Work To Lighten My Periods?
And How Much Lighter Will It Make Them? As I Hate Having That Time Of The Month At School,Also Has Anybody Got Any Ideas To Make My Pads Less Visible,Like Through My Trousers I Always Feel Uncomfortable :(
Dr Frank
Can't help with the pads issue. Tranxenamic is an excellent drug for reducing period loss. It is much under used and under-rated in UK. It is prescribed much more frequently on the Continent and many feel this is why their hysterectomy rates are less than ours.
sexi c
is it safe to take tranexamic acid before surgery ???
i had depo provera shot last month and my period came a week early and has lasted 3 weeks went to dr n he give me those pills i told him i was goin for operation n he seemed he didnt know wat to do he then said stop takin 3 days b4 surgery and dont take ne after for a good few weeks im really scared wat shud i do shud i get a 2nd opinion
Lynn
Ask the surgeon's assistant.
khan shaheb
what is tranexamic acid? and in what decease its use for?
Ajeesh Kumar
Tranexamic acid (commonly marketed as Cyklokapron in the US and as Transamin in Asia) is often prescribed for excessive bleeding. It is an antifibrinolytic that competitively inhibits the activation of plasminogen to plasmin, a molecule responsible for the degradation of fibrin. Fibrin is the basic framework for the formation of a blood clot in hemostasis. It has roughly 8 times the antifibrinolytic activity of an older analogue, ε-aminoacaproic acid.

Menstrual bleeding

Tranexamic acid is commonly used to treat certain types of excessive menstrual bleeding, otherwise known as menorrhagia. UK studies have found that women suffering from menorrhagia often have elevated levels of tissue plasminogen activator, an enzyme responsible for the conversion of plasminogen into plasmin

Haemophilia

Tranexamic acid is also useful in the treatment of bleeding in haemophilia patients (i.e. Tooth extraction in haemophilia patients.

Angioedema

In acquired angioedema types I and II and non-histaminergic angioedema, antifibrinolytics such as tranexamic acid or ε-aminocaproic acid may be effective.

Cardiac surgery

Transexamic acid is used in cardiac surgery, e.g. coronary artery bypass surgery, to prevent excessive blood loss.
krista mae b
drug study for tranexamic acid?
mjb
There are currently 8 ongoing clinical studies looking at tranexamic acid. Here is the link to all eight of them: http://clinicaltrials.gov/ct/search;jses...
Silvia A
formulation that contain tranexamic acid?
Susan S
CYKLOKAPRON Tablets 500 mg (flat, white, round with beveled edges, arcs above and below the letters CY)
Heather y
I was just given some birth control and some tranexamic acid to stop my heavy,prolonged period?
ok...like I said I was just given some stuff to help stop with my heavy,prolonged bleeding. so.....I was curious if anyone else has had to go through the same thing and if so how long did it take to work for you? also....I am worried....what if doesnt work and I need to have something like an hysterectomy?? I am only 28 and do not have any kids and would love to have a few some day, so that would just devastate me! anyways....would there be any other alternatives if the bleeding doesnt stop so I can still preserve my fertility? I am totally freaking out about this! I became anemic because of this stupid thing and had to get a blood transfusion! anyways.....I am hoping some one can please,please,please help me with this! thanks alot!
loveSexy...
I went through this at 16 and am now 27 and regular, I was put on Depo-Provera which worked, the doc had me taking active pills every 4 hours and the bleeding went on for months... I have no kids and not sure if I ever can, but at least you know you are not alone. Good Luck and I hope it stops soon for you.