Propulsid (cisapride)

Propulsid (cisapride) is an oral medication used to treat symptoms of nighttime heartburn due to gastroesophageal reflux disease (GERD). Propulsid is a "prokinetic" agent that increases muscle contractions of the lower esophagus and the lower esophagus sphincter. The lower esophagus sphincter, located between the esophagus and stomach, normally prevents reflux of acid and other stomach contents into the esophagus.

Why Prescribed

Propulsid is prescribed for the treatment of severe nighttime heartburn experienced by adult patients with gastroesophageal reflux disease (GERD).

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FDA Approved Uses

Propulsid was approved by the FDA in tablet form in 1993 and in suspension form in 1995 to treat heartburn and esophagitis due to gastroesophageal reflux.

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Side Effects

Side effects associated with Propulsid use include diarrhea, nausea, headache, stuffy nose, constipation and abdominal pain.

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Warnings and Alerts

On December 31, 1999, the FDA announced that Propulsid had been associated with 341 reports of heart rhythm abnormalities, including 80 reports of deaths. Health professionals were notified that Janssen Pharmaceutica Inc. would stop marketing Propulsid in the United States as of July 14, 2000 due to serious, even fatal heart problems occurring when Propulsid was used alone or with other drugs such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), nefazodone, protease inhibitors (e.g., ritonavir), drugs used to treat irregular heartbeats such as quinidine or sotalol, antidepressants (e.g., tricyclic or certain tetracyclics), antipsychotics (e.g., certain phenothiazines, sertindole), astemizole, sparfloxacin, and terodiline.

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Drug Contraindications

Propulsid should be avoided in patients suffering from intestinal obstruction or perforation. Since Propulsid accelerates stomach emptying, it can increase absorption and effects of other medications. For example, the effects of sedatives such as alcohol and diazepam (Valium) can be accelerated when used together with Propulsid.

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How does Propulsid work?

In patients with gastroesophageal reflux disease (GERD), a weakened lower esophagus sphincter allows reflux of stomach acid into the esophagus, causing heart burn and acid damage to the esophagus (peptic esophagitis). Propulsid decreases stomach acid reflux by strengthening the lower esophagus sphincter, as well as the peristaltic muscle contractions of the lower esophagus. Propulsid also hastens the stomach emptying of solid and liquid meals into the intestines (faster emptying of meals decrease the reflux of stomach acid and other contents into the esophagus).

What is GERD?

GERD (gastroesophageal reflux disease) is a condition in which acid from the stomach flows back (or "refluxes") into the esophagus, which can cause irritation and damage to the lining of the esophagus.

What are the symptoms of GERD?

  • Pain in the chest
  • Hoarseness in the morning
  • Trouble swallowing
  • May feel like food is stuck in the throat
  • Choking sensation
  • Persistent dry cough
  • Bad breath

Are there other medications that are effective for GERD and safer to use than Propulsid?

H2 blockers, such as Tagamet HB (cimetidine), Pepcid AC (famotidine), Axid AR (nizatidine), and Zantac 75 (ranitidine), impede acid production. They are available in prescription strength and over the counter. These drugs provide short-term relief, but over-the-counter H2 blockers should not be used for more than a few weeks at a time.

Proton pump inhibitors include Prilosec (omeprazole), Prevacid (lansoprazole), Protonix (pantoprazole), Aciphex (rabeprazole), and Nexium (esomeprazole), which are all available by prescription. Proton pump inhibitors are more effective than H2 blockers and can relieve symptoms in almost everyone who has GERD. Prilosec is available in an over-the-counter form (Prilosec OTC). Proton pump inhibitors shouldn't be used for more than a few weeks at a time without evaluation by a doctor.

What should I do if I have suffered injuries from using Propulsid?

While all medications have certain, anticipated side effects, a drug manufacturer has a duty to inform physicians adequately regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as "product liability."

If you or a loved one has experienced any health problems from using Propulsid, or if you have lost a loved one due to wrongful death from taking Propulsid, you should contact your doctor immediately and contact an experienced drug litigation attorney to discuss your legal options.

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