LABETALOL

Drugs in Pregnancy and Lactation.

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Name: LABETALOL
Class: Sympatholytic (Antihypertensive)
Risk Factor:    CM*

Fetal Risk Summary

Labetalol, a combined a/b-adrenergic blocking agent, has been used for the treatment of hypertension occurring during pregnancy (1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24, 25,26,27,28 and 29). No teratogenicity was observed in rats and rabbits at oral doses 6 and 4 times the maximum recommended human dose (MRHD), respectively (30). However, increased fetal resorptions occurred in both species at doses approximately equivalent to the MRHD. In rabbits, IV doses up to 1.7 times the MRHD revealed no drug-related fetal harm (30).

Labetalol crosses the human placenta to produce cord serum concentrations averaging 40%–80% of peak maternal levels (1,2,3,4 and 5). Maternal serum and amniotic fluid concentrations are approximately equivalent 1–3 hours after a single IV dose (4). After oral dosing (1–42 days) in eight women, amniotic fluid concentrations of labetalol were in the same range as, but lower than, the plasma concentrations in six of the women (6). The pharmacokinetics of labetalol in pregnant patients have been reported (7,8). A 1988 article briefly reviewed some of the experience with labetalol in pregnancy (31).

In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 29 newborns had been exposed to labetalol during the 1st trimester (F. Rosa, personal communication, FDA, 1993). Four (13.8%) major birth defects were observed (one expected). Details on the malformations were not available, but no anomalies were observed in six defect categories (cardiovascular defects, oral clefts, spina bifida, polydactyly, limb reduction defects, and hypospadias) for which specific data were available. Although the number of exposures is small, the incidence of malformations is suggestive of an association, but other factors, including the mother's disease, concurrent drug use, and chance, may be involved.

No published reports of fetal malformations attributable to labetalol have been located, but experience during the 1st trimester, except for the surveillance study described above, is lacking. Most reports have found no adverse effects on birth weight, head circumference, Apgar scores, or blood glucose control after in utero exposure to labetalol (9,10,11,12 and 13). One case of neonatal hypoglycemia has been mentioned, but the mother was also taking a thiazide diuretic (2). Offspring of mothers treated with labetalol had a significantly higher birth weight than infants of atenolol-treated mothers, 3280 g vs. 2750 g (p<0.001), respectively (14). However, in a study comparing labetalol plus hospitalization with hospitalization alone for the treatment of mild preeclampsia presenting at 26–35 weeks' gestation, labetalol treatment did not improve perinatal outcome, and a significantly higher number of labetalol-exposed infants were growth retarded, 19.1% (18 of 94) vs. 9.3% (9 of 97) (p<0.05), respectively (15).

Fetal heart rate is apparently unaffected by labetalol treatment of hypertensive pregnant women. However, two studies have observed newborn bradycardia in a total of five infants (16,17). In one of these infants, bradycardia was marked (<100 bpm) and persistent (17). All five infants survived. Hypotension was noted in another infant delivered by cesarean section at 28 weeks' gestation (1). In a study examining the effects of labetalol exposure on term (37 weeks or greater) newborns, mild transient hypotension, which resolved within 24 hours, was observed in 11 infants compared with 11 matched controls (18). Maternal dosage varied from 100 to 300 mg 3 times daily with the last dose given within 12 hours of birth. The mean systolic blood pressures at 2 hours of age in exposed and nonexposed infants were 58.8 and 63.3 mm Hg (p<0.05), respectively. Other measures of b-blockade, such as heart and respiratory rates, palmar sweating, blood glucose control, and metabolic and vasomotor responses to cold stress, did not differ between the groups. The investigators concluded that labetalol did not cause clinically significant b-blockade in mature newborn infants (18).

Several investigations have shown a lack of effect of labetalol treatment on uterine contractions (1,2 and 3,16,19,20 and 21). One study did report a higher incidence of spontaneous labor in labetalol-treated mothers (6 of 10) than in a similar group treated with methyldopa (2 of 9) (22). In another report, 3 of 31 patients treated with labetalol experienced spontaneous labor, one of whom delivered prematurely (23). The authors attributed the uterine activity to the drug because no other causes were found. However, because most trials with labetalol in hypertensive women have not shown this effect, it is questionable whether the drug has any direct effect on uterine contractility.

Labetalol does not change uteroplacental blood flow despite a drop in blood pressure (2,4,5,24,25). The lack of effect on blood flow was probably caused by reduced peripheral resistance.

Labetalol apparently reduces the incidence of hyaline membrane disease in premature infants by increasing the production of pulmonary surfactant (1,2,4,16,26). The mechanism for this effect may be mediated through b2-adrenoceptor agonist activity that the drug partially possesses (1,2,4,16,26).

Follow-up studies have been completed at 6 months of age on 10 infants exposed in utero to labetalol (27). All infants demonstrated normal growth and development. In addition, no ocular toxicity has been observed in newborns, even though labetalol has an affinity for ocular melanin (1,2,26).

In summary, the use of labetalol for the treatment of maternal hypertension does not seem to pose a risk to the fetus, except possibly in the 1st trimester, and may offer advantages over the use of agents with only b-blocker activity. However, one study has demonstrated intrauterine growth retardation (IUGR) when the drug was used for the treatment of mild preeclampsia. Some b-blockers may cause IUGR and reduced placental weight (e.g., see Atenolol and Propranolol). Treatment beginning early in the 2nd trimester results in the greatest weight reductions. This toxicity has not been consistently demonstrated in other agents within this class or with labetalol. The lack of toxicity documentation may reflect the number and type of patients studied, the duration of therapy, or the dosage used. Although growth retardation is a serious concern, the benefits of maternal therapy with labetalol (or b-blockers) may, in some cases, outweigh the risks to the fetus and must be judged on a case-by-case basis. As for other toxicity, the majority of newborns have shown no adverse clinical signs after exposure except for mild transient hypotension, but they should be closely observed during the first 24–48 hours for bradycardia, hypotension, and other symptoms of a/b blockade. Long-term (>6 months) studies of infants exposed in utero to labetalol have not yet been conducted.

[*Risk Factor D if used in 2nd or 3rd trimesters.]

Breast Feeding Summary

Labetalol is excreted into breast milk (1,6). In 24 lactating women, 3 days postpartum, administration of 330–800 mg/day produced a mean milk level of 33 ng/mL. No adverse effects were observed in the nursing infants. One patient, consuming 1200 mg/day, had a mean milk concentration of 600 ng/mL, but this woman did not breast-feed. Three women, 6–9 days postpartum, consumed daily doses of labetalol of 600, 600, and 1200 mg and produced peak milk concentrations of the drug of 129, 223, and 662 ng/mL, respectively (6). Peak concentrations of labetalol in the milk occurred between 2–3 hours after a dose. Measurable plasma concentrations of labetalol were found in only one infant: 18 ng/mL at 4 hours and 21 ng/mL at 8 hours. Although no adverse effects have been reported, nursing infants should be closely observed for bradycardia, hypotension, and other symptoms of a/b-blockade. Long-term effects of exposure to labetalol from milk have not been studied but warrant evaluation. The American Academy of Pediatrics considers labetalol to be compatible with breast feeding (32).

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References

  1. Michael CA. Use of labetalol in the treatment of severe hypertension during pregnancy. Br J Clin Pharmacol 1979;8(Suppl 2):211S–5S.
  2. Riley AJ. Clinical pharmacology of labetalol in pregnancy. J Cardiovasc Pharmacol 1981;3(Suppl 1):S53–S9.
  3. Andrejak M, Coevoet B, Fievet P, Gheerbrant JD, Comoy E, Leuillet P, Verhoest P, Boulanger JC, Vitse M, Fournier A. Effect of labetalol on hypertension and the renin-angiotensin-aldosterone and adrenergic systems in pregnancy. In Riley A, Symonds EM, eds. The Investigation of Labetalol in The Management of Hypertension in Pregnancy. Amsterdam:Excerpta Medica, 1982:77–87.
  4. Lunell NO, Hjemdahl P, Fredholm BB, Lewander R, Nisell H, Nylund L, Persson B, Sarby J, Wager J, Thornstrom S. Acute effects of labetalol on maternal metabolism and uteroplacental circulation in hypertension of pregnancy. In Riley A, Symonds EM, eds. The Investigation of Labetalol in The Management of Hypertension in Pregnancy. Amsterdam:Excerpta Medica, 1982:34–45.
  5. Nylund L, Lunell NO, Lewander R, Sarby B, Thornstrom S. Labetalol for the treatment of hypertension in pregnancy. Acta Obstet Gynecol Scand 1984;118(Suppl):71–3.
  6. Lunell NO, Kulas J, Rane A. Transfer of labetalol into amniotic fluid and breast milk in lactating women. Eur J Clin Pharmacol 1985;28:597–9.
  7. Rubin PC. Drugs in pregnancy. In Riley A, Symonds EM. eds. The Investigation of Labetalol in The Management of Hypertension in Pregnancy. Amsterdam:Excerpta Medica, 1982:28–33.
  8. Rubin PC, Butters L, Kelman AW, Fitzsimons C, Reid JL. Labetalol disposition and concentration-effect relationships during pregnancy. Br J Clin Pharmacol 1983;15:465–70.
  9. Lamming GD, Broughton Pipkin F, Symonds EM. Comparison of the alpha and beta blocking drug, labetalol, and methyl dopa in the treatment of moderate and severe pregnancy-induced hypertension. Clin Exp Hypertens 1980;2:865–95.
  10. Lotgering FK, Derkx FMH, Wallenburg HCS. Primary hyperaldosteronism in pregnancy. Am J Obstet Gynecol 1986;155:986–8.
  11. Mabie WC, Gonzalez AR, Sibai BM, Amon E. A comparative trial of labetalol and hydralazine in the acute management of severe hypertension complicating pregnancy. Obstet Gynecol 1987;70:328–33.
  12. Plouin P-F, Breart G, Maillard F, Papiernik E, Relier J-P. Comparison of antihypertensive efficacy and perinatal safety of labetalol and methyldopa in the treatment of hypertension in pregnancy: a randomized controlled trial. Br J Obstet Gynaecol 1988;95:868–76.
  13. Pickles CJ, Symonds EM, Broughton Pipkin F. The fetal outcome in a randomized trial of labetalol versus placebo in pregnancy-induced hypertension. Br J Obstet Gynaecol 1989;96:38–43.
  14. Lardoux H, Gerard J, Blazquez G, Chouty F, Flouvat B. Hypertension in pregnancy: evaluation of two beta blockers atenolol and labetalol. Eur Heart J 1983;4(Suppl G):35–40.
  15. Sibai BM, Gonzalez AR, Mabie WC, Moretti M. A comparison of labetalol plus hospitalization versus hospitalization alone in the management of preeclampsia remote from term. Obstet Gynecol 1987;70:323–7.
  16. Michael CA, Potter JM. A comparison of labetalol with other antihypertensive drugs in the treatment of hypertensive disease of pregnancy. In Riley A, Symonds EM. eds. The Investigation of Labetalol in The Management of Hypertension in Pregnancy. Amsterdam:Excerpta Medica, 1982:111–22.
  17. Davey DA, Dommisse J, Garden A. Intravenous labetalol and intravenous dihydralazine in severe hypertension in pregnancy. In Riley A, Symonds EM, eds. The Investigation of Labetalol in The Management of Hypertension in Pregnancy. Amsterdam:Excerpta Medica, 1982:52–61.
  18. MacPherson M, Broughton Pipkin F, Rutter N. The effect of maternal labetalol on the newborn infant. Br J Obstet Gynaecol 1986;93:539–42.
  19. Redman CWG. A controlled trial of the treatment of hypertension in pregnancy: labetalol compared with methyldopa. In Riley A, Symonds EM, eds. The Investigation of Labetalol in The Management of Hypertension in Pregnancy. Amsterdam:Excerpta Medica, 1982:101–10.
  20. Walker JJ, Crooks A, Erwin L, Calder AA. Labetalol in pregnancy-induced hypertension: fetal and maternal effects. In Riley A, Symonds EM, eds. The Investigation of Labetalol in The Management of Hypertension of Pregnancy. Amsterdam:Excerpta Medica, 1982:148–60.
  21. Thulesius O, Lunell NO, Ibrahim M, Moberger B, Angilivilayil C. The effect of labetalol on contractility of human myometrial preparations. Acta Obstet Gynecol 1987;66:237–40.
  22. Lamming GD, Symonds EM. Use of labetalol and methyldopa in pregnancy-induced hypertension. Br J Clin Pharmacol 1979;8(Suppl 2):217S–22S.
  23. Jorge CS, Fernandes L, Cunha S. Labetalol in the hypertensive states of pregnancy. In Riley A, Symonds EM, eds. The Investigation of Labetalol in The Management of Hypertension of Pregnancy. Amsterdam:Excerpta Medica, 1982:124–30.
  24. Lunell NO, Nylund L, Lewander R, Sarby B. Acute effect of an antihypertensive drug, labetalol, on uteroplacental blood flow. Br J Obstet Gynaecol 1982;89:640–4.
  25. Jouppila P, Kirkinen P, Koivula A, Ylikorkala O. Labetalol does not alter the placental and fetal blood flow or maternal prostanoids in pre-eclampsia. Br J Obstet Gynaecol 1986;93:543–7.
  26. Michael CA. The evaluation of labetalol in the treatment of hypertension complicating pregnancy. Br J Clin Pharmacol 1982;13(Suppl):127S–31S.
  27. Symonds EM, Lamming GD, Jadoul F, Broughton Pipkin F. Clinical and biochemical aspects of the use of labetalol in the treatment of hypertension in pregnancy: comparison with methyldopa. In Riley A, Symonds EM, eds. The Investigation of Labetalol in The Management of Hypertension in Pregnancy. Amsterdam:Excerpta Medica, 1982:62–76.
  28. Smith AM. Beta-blockers for pregnancy hypertension. Lancet 1983;1:708–9.
  29. Walker JJ, Bonduelle M, Greer I, Calder AA. Antihypertensive therapy in pregnancy. Lancet 1983;1:932–3.
  30. Product information. Normodyne. Schering, 2000.
  31. Frishman WH, Chesner M. Beta-adrenergic blockers in pregnancy. Am Heart J 1988;115:147–52.
  32. Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 1994;93:137–50.

Index

Q&A about Labetalol

erickand...
What is the best way to transition from Diovan HCT 80/15 mg to Labetalol for pregnancy?
I currently take Diovan and have to move to Labetalol.
pizza lover!
i dont really gat your question,sorry
ajoytale...
Has anyone taken the beta blocker Labetalol ? I am pregnant and being told to switch to this one?
Did you have any side effects etc
Ruth
Did you have high blood pressure before you became pregnant or is your high blood pressure because of the pregnancy ( Pregnancy Induced ) ?? What med were you on previously ?? I ask these questions because it will affect my answer. Labetalol is frequently prescribed for pregnancy induced high blood pressure.This can be a sign of pre-eclampsia. If your Doc switched you to this medication then, you should be ok. The side effects:

Drowsiness, fatigue ( feeling tired), weakness, difficulty sleeping,diminished sexual function, scalp tingling ( this will pass after time). However, this doesn't mean that you will get these side effects. The drug companies have to list every sign or symptom of side effects. If you were previously taken medication for your blood pressure, your body is used to being on such medications. If you do develop some of these side-effects that do not go away or they persist or worsen, let your Doc know. You should reduce your salt intake and watch for swelling of your hands, feet, puffiness of your face or near your eyes, headaches or any change in your vision. I hope that this helps. Congrats on your pregnancy.
CAROL T
Has anyone had good readings with the bp drug Labetalol?
My husband has been on it along with the drug tekturna and it has been a week and his readings are still in the 150's. His pulse rate however is down to the 50's.
ralphrep...
I'm sure there are many people who have taken Labetalol and have it do nothing for their BP. Which is why people have to go to doctors. The doctor will look at an individual patient's response and make adjustments accordingly. Speaking of which, the heart rate in the 50's could be a concern. And a BP of 150 isn't all that bad to begin with.

Ralph
MIRACLE
Has anyone had severe tiredness and weakness after taking Labetalol?
After having my baby on 2/9/08 i developed hypertension. I was put on Labetalol 200 mg. 2 in the morning and 2 before bed. i noticed servere weakness and tiredness. i would be exhausted just walking and walking up stairs. the doctor finally took me off of it but i still have unexplained weakness and tiredness after being off the medication for 9 days now. please anyone with any personal experience or know about any side affects like i'm having from this medication please advise.
Bufford M
This is an exceedingly common side effect, especially at high doses (which you were on)

The effects will wear off. Labetolol isn't a really long half life medication, and I'm a bit surprised you are still having effects. It is unusual, by the way, to develop hypertension AFTER having a baby. Much more common is to develop hypertension during pregnancy ( known by the acronym PIH ), and then become normotensive after delivery.

I would suggest that you really need a thorough work up to determine why you developed hypertension at such an unusual time.

Best of luck
thetford...
Anyone taken Labetalol for high blood pressure in pregnancy?
I had high blood pressure before pregnancy. I watch my sodium intake and drink plenty of water, plus I'm taking 2(200mg) of Labetalol 3x a day. Has anyone done this before? Heard of birth defects or anything?
β™₯ lani s
I had high blood pressure during pregnancy of my fourth child but I was prescribed a Methldopa (Aldomet) which was taken 2x daily along with controlled sodium on the diet and modified diet. My boy is now 6 months without any defect and is perfectly healthy.

Labetalol is used to control blood pressure during pregnancy with proper caution as it lowers blood pressure very quickly. It is usually used during the last stage of pregnancy or delivery. I had known some who had taken it without harm caused to the baby, the only possible effect would be the size of the baby which could become a bit smaller. Just watch your sodium intake and the diet as well. Take care.
Isis Grace
Labetalol during pregnancy to reduce high blood pressure?
Have any women taken this medication during pregnancy for chronic hyper tension? I started taking it today and I am curious about other experience with this drug. My dr. first prescribed me Methyldopa (aka Aldomet) which made me so sick, I couldn't function. Now I am taking Labetalol.
Jen, RN
I have many patients that take this. Hopefully the Lebetalol won't cause any vomiting. Any Beta Blocker though will cause lowering of your heart rate, so you may feel like you don't have as much energy, may gain a little more weight with it. But it is very important to keep that blood pressure down. Good luck to you!
supersta...
What does this mean? Labetalol carries the contraindications of a nonselective beta blocker.?
I read this in my pharmacology textbook but I still don't understand what this sentence means.
Mickey D
Nonselective beta blockers are not supposed to be used in certain cases; they are contraindicated. Labetalol acts just as they do and should similarly not be used in those same conditions. For instance, non selective beta blockers are contraindicated in patients with asthma or chronic obstructive pulmonary disease.

The sentence says that the same goes for Labetalol. Same contraindications.
ME
what are the side affects of the blood pressure medicine called labetalol?
Soul Doctor
Labetalol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

dizziness

tingling scalp or skin

lightheadedness

excessive tiredness

headache

upset stomach

stuffy nose

If you experience any of the following symptoms, call your doctor immediately:

shortness of breath or wheezing

swelling of the feet and lower legs

sudden weight gain

chest pain

Take Care and God Bless you !

P.S

I would pay special attention to what "Vrishabha" has said above me, Sound advice !

And the THUMBS DOWN besides my answer tells you that the Medical Industry of conventional medicine does not wants you to know about the side effects of whatever medication you are taking and that is exactly what you have to do. Because its your health. :o)

Best of Health to You.
rain6270
Is labetalol the best drug for mitral valve prolapse?
josephs
Hey don't freak out I have Mitral Valve Prolapse wih severe regurguitation and just has open heart surgery, the fact that the docs have you on medication means that you do not require surgery. Some people can live with as mitral valve problem their whole life. If you are an Amercian rest assured you are the leading people in heart research the actual operation is not so bad after 5 days I was released from hospital. I cannot give you any info about labetalol but I can give you some advice about the mitral valve. Ask you doctors what their opinion of surgery is ask weather they think it is repairable or will need to be replaced if it cant be repaired then you will need to be on medication for the rest of your life.

The reason I had my surgery at the age of 27 was that the doctor said if I had surgery now there would be a good chance of repair whereas if I waited the valve may be too damaged and I would need it replaced, turns out they repaired it. All the best