Cisapride Risk Summary

Risk Factor: CM
Class: GASTROINTESTINAL AGENTS / Stimulants

Fetal Risk Summary

Cisapride, an oral gastrointestinal prokinetic agent, was withdrawn from the market in the United States in July 2000 because of the risk of serious cardiac arrhythmias and death. The drug is available only through an investigational, limited access program sponsored by the manufacturer.

In female rats, doses of 40 mg/kg/day (25 times the maximum recommended human dose [MRHD]) impaired fertility by prolonging the breeding interval required for conception (1). Similar fertility impairment was observed at maturity in female rats exposed in utero to maternal doses of 10 mg/kg/day. Cisapride was embryotoxic and fetotoxic at doses 12 and 100 times the MRHD in rabbits and rats, respectively (1). Intrauterine growth retardation and increased neonatal mortality were also observed.

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 (2). 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 have been taken during the 1st trimester with birth defects noted in 14 (2.5%) singleton births of the 557 newborns (10 sets of twins). In addition, two birth defects were observed in aborted fetuses. However, few of the aborted fetuses were examined. Cisapride was taken during the 1st trimester in 12 pregnancies. The outcomes of these pregnancies included 2 elective abortions, 1 lost to follow-up, and 10 normal, term babies (one set of twins). In two other cases, cisapride was taken during the 2nd and/or 3rd trimesters (2).

A 1997 prospective multicenter compared the pregnancy outcomes of 129 subjects who had taken cisapride during pregnancy with two groups of matched controls (3). Outcomes included major and minor malformations, birth weight (including birth weight <2500 g), live births (including premature births), spontaneous or induced abortions, fetal distress, and gestational age at birth. All of the subjects and controls had contacted one of 10 antenatal counseling services. The mean daily cisapride dose was 25 mg (range 5120 mg), and the mean length of exposure was 4.6 weeks (range 0.1441 weeks). Among 113 (87.6%) subjects who had taken cisapride during the 1st trimester, 88 (68.2%) had taken it during the period of organogenesis. There were no significant differences in outcomes between the subjects and controls (3).

In summary, cisapride is not an animal teratogen in two species, although embryo and fetal toxicity were observed at doses above the maximum human dose, and it does not appear to be a major human teratogen. However, the data are still too limited to adequately assess the safety of cisapride. Moreover, the studies lacked sensitivity to identify minor anomalies because of the absence of standardized examinations. Late appearing major defects may also have been missed due to the timing of the questionnaires.

Breast Feeding Summary

Cisapride is excreted into human milk (4). Ten women in the immediate postpartum period (mean 1.2 days after delivery), who had elected not to breast-feed their infants, were administered the drug 20 mg orally every 8 hours for 4 days. Milk samples were collected on the 3rd and 4th days before and 1 hour after a dose. A single serum sample was obtained on the 4th day 1 hour after a dose. The mean milk concentrations just before a dose on days 3 and 4 were 4.2 ng/mL and 4.8 ng/mL, respectively, whereas on both days the mean concentrations in the 1-hour samples were 6.2 ng/mL. The serum level at this time was 137 ng/mL, yielding a milk:serum ratio of 0.063. The investigators estimated that a breast-feeding infant would have ingested 1 g/kg/day of the drug, about 0.1% of the mother's dose, an amount 600 to 800 times lower than the usual therapeutic dose for an infant (4).

Although nursing infants were not involved in the above study, the American Academy of Pediatrics considers the drug to be compatible with breast feeding (5).

References

1. Product information. Propulsid. Janssen Pharmaceutical, 1994.
2. 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.
3. Bailey B, Addis A, Lee A, Sanghvi K, Mastroiacovo P, Mazzone T, Bonati M, Paolini C, Garbis H, Val T, De Souza CFM, Matsui D, Schechtman AS, Conover B, Lau M, Koren G. Cisapride use during human pregnancy. A prospective, controlled multicenter study. Dig Dis Sci 1997;42:184852.
4. Hofmeyr GJ, Sonnendecker EWW. Secretion of the gastrokinetic agent cisapride in human milk. Eur J Clin Pharmacol 1986;30:7356.
5. Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 1994;93:13750.
   
   

Questions and Answers

Has anyone noticed any side effects once their cat started Cisapride ?, My cat has been on Cisapride for about a month now. Since he has started on it he only eats half of what he used to. Just to check I didn't give him his pills for one full day and he went back to eating his regular amount. Anyone else experienced this ?

No, but my cat has only been on Cisapride for a couple of weeks. She's got the topical stuff that I have to smear on her ear. Her appetite has actually increased a little now that she's on it.

Does the vet have any ideas?

Great responses, thank you. I have obtained prescription for Cisapride, what should I watch out for?, I live in Mexico during the summer so getting the good food down here is nonexistent. I have been cooking chicken breasts and ground turkey and he likes that . What dosage do you give for your cat? Communication problems at the farmacia might be a problem for me. Thanks again

Please don't give your cat/kitten COOKED turkey and chicken. The cat needs to have it RAW. When meat is cooked the taurine is destroyed and that is an essential amino acid for a cat which it cannot make in its body as dogs and humans can.

You should be able to get wholesome meat from small markets in Mexico - in the States it is hard to find meat (especially ground meat) that is not mass-produced and packaged for sale.

You might be able to find powdered taurine at a pharmacia which you could add to cooked meat. It's still best to feed it raw with uncooked bones from the wings and ribs for the calcium which is also necessary to balance the phosphorus/calcium ratio with the lean muscle meat. Hearts and livers from raw chicken are also good elements to have in your cat's diet.

Where can I purchase Cisapride for my cat & What should it look like?,

Isn't this a prescription?
Ask your vet :)

Can someone tell me how long it takes Cisapride to work in an older cat?, My cat foams a little in the mouth when I give it to him. Is that the medicine working? Today is his second day on it and I haven't seen any change in his constipation. Thanks in advance!

The med usually takes about 2-3 days at least to notice change. He may be foaming because of the taste. I offer a half teaspoon of wet cat food immediately after dosing, and my cat completely forget what just happened. If you have been prescribed Cisapride, you may always have to keep an eye out for bowel changes - my guy has been on this med off and on for 8 years. The last time he went off for 2 months, and his intestines swelled up and were painful. Now he also gets a sprinkle of unflavored Metamucil in a spoonful of wet food every day - just to help keep things moving. If he hasn't had a bowel movement in the next 24 hours, the vet may have to give an enema - a very unpleasant situation for both of you . . .

Cisapride for cats?, My cat has been struggling with chronic constipation for months. After trying numerous treatments, my vet suggested Cisapride. Can someone please tell me their personal experiences with this drug? Did it help their cat? I also hear it is very expensive because it is compounded. How much did you pay?

Please don't cut and paste articles from Google. I already scoured web sites. I want to hear personal stories about Cisapride's effectiveness.

Cisapride is very expensive and my vet will prescribe that as a last resort for constipation. We call the prescription in to a local pharmacy so they can make it up. Unfortunately, I don't know off hand what the price is.

He usually starts a patient out on Lactulose (Enulose) and many have had great results with that. That's about 11.00 a bottle. He may also recommend a change in food (Hill's has a wet food we sell I believe it's w/d high fiber) that should help keeping things moving.

Did he say why he believes your cat is consitipated? Is it a hairball problem or IBD? Did he check for a blockage?

what happens before and after taking cisapride?,

cis-4-amino-5-chloro-N-[1-
[3-(4-fluorophenoxy)propyl]-3-methoxy-...
2-methoxybenzamide
CAS number:81098-60-4
ATC code:A03FA02
Chemical formula: C23H29ClFN3O4
Molecular weight: 465.9
Bioavailability: ~100%
Metabolism: hepatic, intestinal
Elimination half life: 10 hours
Excretion: renal, biliary
Pregnancy category: B1 (Australia)
Legal status: Schedule 4 (Australia)
Delivery: tablets, suspension

Cisapride increases muscle tone in the esophageal sphincter in people with gastroesophageal reflux disease. It also increases gastric emptying in people with diabetic gastroparesis. It has been used to treat bowel constipation.

In many countries it has been either withdrawn or has had its indications limited due to reports about long QT syndrome due to cisapride, which predisposes to arrhythmias.

What herbs are used as laxatives for cats?, My cat has megacolon and once again is unable to pass the hard fecal matter. He is 13 and no more surgeries can be done. Have tried suppositories and enemas. There has to be something to soften the stool and reduce it's size in order to pass. Already tried Cisapride and other medications. I won't give up on him but don't want him to suffer. Please help me find a solution. Thanks

Has he had the colonectomy surgery?

My cat has just been diagnosed with Mega colon. She gets lactulose and cisapride. Any advice??,

mine just got the same meds for his "issues". I am able to put the lactulose in his wet food, and shove the cisapride in a kitty treat - easier to get him the meds that way. Watch for loose poops after a couple days and call vet if it continues, or if he/she seems to have abdominal cramps. No table food and DEFNITIELY no IAMS.

Does anyone know of a good suppliment or food addative that will help alleviate constipation in an older cat?, We have 6 cats. We feed both wet & dry food. Simon (the oldest) although in relatively good physical shape has a problem with constipation. Our vet prescribed two stool softener pills and 2ml of cisapride daily. Simon is so finicky about which wet food he will eat we can't depend on him getting the cisapride by putting it in his wet food. Previously he was on lactulose and cisapride orally, but we have gone now to the stool softeners and cisapride, because trying to squirt 2 different liquids down his throat every day was too tramatic for him. He hides now out of fear of getting his medications. We are hoping someone knows of another suppliment or medication that cats will readily eat mixed with wet food or that is easily tolerated when given orally that will keep him regular. The softeners work for a couple weeks, when we can manage to get two down him daily and he doesn't later throw them up, but after about 3 weeks its back to the vet for another enema. Any Suggestions?

I give my cats pure pumpkin out of a can not the pumpkin pie mix you want pure pumpkin. I mix that with a bit of yogurt in their food and they love it.Good luck;^)

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