Lansoprazole
Risk Factor: BM
Class: GASTROINTESTINAL AGENTS
/ Antisecretory Agents
Contents of this page:
Fetal Risk Summary
Breast Feeding Summary
References
Questions and Answers
Fetal Risk Summary
Lansoprazole is a proton pump inhibitor that blocks gastric acid secretion by a direct inhibitory effect on the gastric parietal cell (1). It is used for the treatment of gastric and duodenal ulcer, erosive esophagitis, gastroesophageal reflux disease (GERD), and pathologic hypersecretory conditions, such as Zollinger-Ellison syndrome. It is also used in combination with amoxicillin and/or clarithromycin for Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence.
Reproductive studies have been conducted in pregnant rats and rabbits at oral doses up to 40 and 16 times, respectively, the recommended human dose based on body surface area (1). No evidence was found that these doses impaired fertility or caused fetal harm. Similar to other proton pump inhibitors, lansoprazole is carcinogenic in mice and rats producing dose-related gastric, testicular, and liver tumors (1). In addition, positive results were seen with lansoprazole in the in vitro human lymphocyte chromosomal aberration assays, but the Ames mutation assay and other genotoxic animal tests were negative (1).
In a study published in 1990, lansoprazole at a dose of 50 or 300 mg/kg was not teratogenic in pregnant rats, but a decrease in fetal weight occurred (2). Schardein also cited a 1990 study, which appears to be similar to the one cited above, that found no evidence of teratogenicity in rats and rabbits (3).
It is not known if lansoprazole crosses the human placenta. The molecular weight (about 369) is low enough, however, that passage to the fetus should be expected. Another proton pump inhibitor, omeprazole, has a molecular weight (about 345) and chemical structure that is very similar to lansoprazole, and it is known to cross the human placenta (see Omeprazole).
A 1998 non-interventional observational cohort study described the outcomes of pregnancies in women who had been prescribed one or more of 34 newly marketed drugs by general practitioners in England (4). Data were obtained by questionnaires sent to the prescribing physicians one month after the expected or possible date of delivery. In 831 (78%) of the pregnancies, a newly marketed drug was thought to had been taken during the 1st trimester with birth defects noted in 14 (2.5%) singleton births of the 557 live newborns (10 sets of twins). In addition, two birth defects were observed in aborted fetuses. However, few of the aborted fetuses were examined. Lansoprazole was taken during the 1st trimester in six pregnancies. Seven healthy newborns (one premature; one set of twins) were delivered (4).
Data from the Swedish Medical Birth Registry were presented in 1998 (5). A total of 553 infants (6 sets of twins) were delivered from 547 women who had used acid-suppressing drugs early in pregnancy. A number of other pharmaceutical agents, identified only by drug category, were also used by these women. Seventeen infants with birth defects were identified (3.1%; 95% Confidence Interval [CI] 1.84.9) compared with the crude malformation rate of 3.9% in the Registry. The odds ratio (OR) for a congenital malformation, stratified for birth year, maternal age, parity, and smoking was 0.72 (95% CI 0.411.24) (5). The OR for malformations after proton pump blocker exposure was 0.91 (95% CI 0.451.84) compared to 0.46 (95% CI 0.171.20) for H2-receptor antagonists (OR 0.86, 95% CI 0.332.23; p=0.13). Of the 17 infants with birth defects, 10 had been exposed to proton pump blockers, 6 to H2 antagonists, and 1 to both classes of drug. Six of the defects in the proton pump inhibitor group were cardiovascular defects (see also Omeprazole), whereas only one such defect occurred in those exposed to H2 antagonists. Lansoprazole was the only acid-suppressing drug exposure in 13 infants. Two birth defects were observed in this group: atrial septum defect and an undescended testicle (5).
In a study published in 1999, investigators linked data from a Danish prescription database to a birth registry to evaluate the risks of proton pump inhibitors for congenital malformations, low birth weight, and preterm delivery (<37 weeks') (6). From a total of 51 women who had filled a prescription for these drugs sometime during pregnancy, 38 (omeprazole N=35, lansoprazole N=3) had done so during the interval of 30 days before conception to the end of the 1st trimester. A control group, consisting of 13,327 pregnancies in which the mother had not obtained a prescription for reimbursed medication from 30 days before conception to the end of her pregnancy, was used for comparison. The prevalence of major congenital anomalies in controls was 5.2%. Three major birth defects (7.9%), two of which were cardiovascular anomalies, were observed from the 38 pregnancies possibly exposed in the 1st trimester (specific drug exposure not given): ventricular septum defect; pyloric stenosis; and one case of patent ductus arteriosus, atrial septum defect, hydronephrosis, and agenesis of the iris. In comparison to controls, the adjusted (for maternal age, birth order, gestational age, and smoking, but not for alcohol abuse) relative risks for the three outcomes were congenital malformations 1.6 (95% CI 0.55.2), low birth weight 1.8 (95% CI 0.213.1), and preterm delivery (not adjusted for gestational age) 2.3 (95% CI 0.96.0). Although the study found no elevated risks for the three outcomes, the investigators cautioned that more data were needed to assess the possible association between proton pump inhibitors and cardiac malformations or preterm delivery (6).
In summary, the lack of teratogenicity in animals is reassuring, but the limited human pregnancy experience prevents an assessment of the risk from this drug. Birth defects, including cardiac defects, have been reported in pregnancies exposed to a proton pump inhibitor (see also Omeprazole), but there is no evidence of a causal association. Most likely, the observed defects were the result of many factors, including possibly the severity of the disease and concurrent use of other drugs. The data do warrant continued investigation. In addition, the studies lacked the sensitivity to detect minor anomalies because of the absence of standardized examinations. Late appearing major defects may also have been missed due to the timing of some data collection. The carcinogenicity data are a potential concern, but the dose-related nature of the tumors and the presumable limited in utero exposure to the drug during human gestation probably indicates a negligible risk. However, as with all drug therapy, avoidance of lansoprazole during pregnancy, especially during the 1st trimester, is the safest course. If lansoprazole is required or if inadvertent exposure does occur early in gestation, the known risk to the embryo/fetus appears to be low. Long-term follow-up of offspring exposed during gestation is warranted.
Breast Feeding Summary
No reports describing the use of lansoprazole during human lactation have been located. Both lansoprazole and its metabolites are excreted in the milk of lactating rats (1), and their excretion in human milk should be expected. Because of the carcinogenicity observed in animals, and the potential for suppression of gastric acid secretion in the nursing infant, the use of lansoprazole during lactation should probably be avoided.
References
- Product information. Prevacid. Tap Pharmaceuticals, 2001.
- Schardein JL, Furuhashi T, Ooshima Y. Reproductive and developmental toxicity studies of lansoprazole (ag-1749) in rats and rabbits. Yakuri to Rinsho 1990;18:S277383. As cited by Shepard TH. Catalog of Teratogenic Agents. 8th ed. Baltimore:Johns Hopkins University Press, 1995:245.
- Schardein JL, Furuhashi T, Ooshima Y. Reproductive and developmental toxicity studies of lansoprazole (AG-1749) in rats and rabbits. Jpn Pharmacol Ther 1990;18(Suppl 10):11929. As cited by Schardein JL. Chemically Induced Birth Defects. 2nd ed. New York:Marcel Dekker, 1993:447.
- Wilton LV, Pearce GL, Martin RM, Mackay FJ, Mann RD. The outcomes of pregnancy in women exposed to newly marketed drugs in general practice in England. Br J Obstet Gynaecol 1998;105:8829.
- Kallen B. Delivery outcome after the use of acid-suppressing drugs in early pregnancy with special Reference to omeprazole. Br J Obstet Gynaecol 1998;105:87781.
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Nielsen GL, Sorensen HT, Thulstrup, Tage-Jensen U, Olesen C, Ekbom A. The safety of proton pump inhibitors in pregnancy. Aliment Pharmacol Ther 1999;13:10859.
Questions and Answers
I have been taking 30mg lansoprazole in morning and 300 mg Zantac at night for 6 months?, The Doctor prescibed due to small ulcers and gastritus seen in endoscopy. Both my father and two grandfathers suffered from same.Is it safe to take long term,as soon as i have a break from them, the pain returns,have been taking lansoprazole on and off for ten years.
Like Denise said.. you should bring this up to your doctor.. but, I can tell you that Im going through the same thing, and have been taking these medicines for 5yrs.. the only thing that changes for me is I get immuned to them and then the doc has to up the dosage.. so, I dont think he'd up the dosage and let me be taking them for so long if it were dangerous... GOOD LUCK!!!!
I have been taking lansoprazole 30mg for two months for confirmed endoscopy peptic ulcers?, As the pain and sickness has not improved, I have been prescribed zantac.which after five days has improved the pain and sickness.
Is it because zantac if more expensive,than lansoprazole.
They act in different ways. Zantac is an antihistamine and reduces the effect of the histamines in the stomach that cause acid to be produced. Lanzaprosole is a Proton-pump inhibitor which has a direct effect on the acid producing bits of your stomach, also by inhibiting the action of a chemical. Not sure why one has worked better for you but since it has, stick with it.
Is it safe to drink alcohol whilst on Lansoprazole tablets?, I dont mean excessive, go out n get plastered drinking.
Just a bottle of wine (shared between 2) or a few pints of cider.
Yes it's fine. I've been on Lanzoprazole and Omeprazole for years, and never, ever had any problems with the occasional glass of wine. Both are proton pump inhibitors - they just limit the amount of acid your stomach produces. They do not effect alcohol metabolism, in other words, will not make you feel more, or less, drunk or ill .
All drugs come with a health warning - even paracetamol and ulcer cream. They have to cover their butt's...but if you don't feel comfortable with it, don't do it! Whatever happens..it wont kill you :)
Cheers (hic)
Can I take 30mg Lansoprazole caspules to Thailand?, Hi I am taking 30mg Lansoprazole caspules for my stomach acid. I am go to Thailand for 2 weeks in April. Does anyone know if I can take these tablets with me please. Thank you for your help.
I take the same medication as you and I take Lansoprazole with me every time I visit Thailand.If you run out of the medication you can buy medical drugs over the counter ,which I usually get at Boots chemist in Pattaya.
I have been taking lansoprazole 30 mg for six months?, as diagnosed by endoscopy with gastritus with small ulcers in stomack.I am still getting pain and burning above navel at night, why is this.
Cant tell you why, but I have just been prescribed those and it says on the help sheet not to take them for longer than a month as there effectiveness will wear off.
Google ways to control the acid with diet, I tried this and the general advice was the same as most sensible eating plans. Don't eat late at night, small and often portions, cut back on alcohol, the usual.
It also said try raising the head end of your bed to create an incline, this may help with the acid reflux.
Apart from that, best you ask a doctor. good luck
Is the gelatine used in Lansoprazole capsules of animal or vegetable origin?,
animal origin sure of that
I get burning in the back of my throat after I eat. The doctor has prescribed me Lansoprazole - is this right?, I don't smoke, drink caffeine, eat chocolate. I rarely drink alcohol and I tend to just drink water.
I have been prescribed lansoprazole for gastric reflux as anything i eat..whether it be bland or not seems to stay in the upper part of my gullet. I get burning and my throat and nose bleeds with this. I am sick every day and am due to see a gasterologist about it soon. It has been a long term problem for me. If the tablets are working then great as they are supposed to relieve it.Unfortunately they dont for me.If it gets worse then go back to your GP for more tests.
take care XX
is any one on lansoprazole and clopidogrel, if so do the two together cause any interactions?, I have read so many problems with the two makes me wonder if its worth it all.
Thank you.
Hi, there is no drug interaction between lansoprazole and Clopidogrel. All medication has side effects, most of the time people don't experience major side effects.
If you are experiencing side effects that are impeding on your life, then have a chat with your Dr- there other medications. There is never a 'one pill suits all'. With all drugs, there is a risk benefit ratio and this should always be taken into consideration.
It's very important that you take Clopidogrel if you have been prescribed it, don't stop taking your medication without speaking with your Dr first.
does lansoprazole slows gallbladder motility?, They says my gallbaldder motility has reduced to 18%. I was taking the Lansoprazole for sometime. Does this medicine causes slow in Gall motility. I feel a heaviness around the area. Is there any medicice which can improve the Gall motility?
Thanks in advance.
no relation between the two , gall bladder is not motile but contractile ,
