Expanded Access Program

The Suzi and Scott Lustgarten Center for GI Motility at Children’s Hospital of Philadelphia (CHOP) offers cisapride and domperidone through expanded access programs. These medications can treat a variety of motility disorders including: gastroesophageal reflux disease with upper GI symptoms, gastroparesis, chronic constipation and other problems with food moving through the digestive system. Although these drugs were removed from the market, some patients may receive benefit from these therapies. With that in mind the FDA has granted special permission for these drugs to be made available and used for treatment when no other treatments have been effective and no suitable alternative is available.

Domperidone Expanded Access Protocol is used to treat serious gastrointestinal motility disorders in patients that are at least 12 years old. Domperidone does not cross the blood-brain barrier causing less nervous system side effects. Domperidone can cause increased risk for cardiac issues like irregular heartbeat and therefore the protocol is regulated by the U.S. Food and Drug Administration. Patients require close cardiac monitoring and frequent visits with their gastroenterologist. There are specific eligibility criteria and your GI physician will let you know if you are a candidate.

Cisapride Limited Access Program is another option available to patients for refractory motility disorders. Cisapride is a gastrointestinal, prokinetic agent that increases motility in the gastrointestinal tract by increasing the excitability of the esophagus, small intestine and colon. Cisapride is regulated by the FDA and is only available at select highly specialized institutions. A risk of cisapride is serious cardiac arrhythmias and for this reason the medication can only be prescribed and dispensed by participating providers to ensure careful monitoring. Patients must meet very strict eligibility criteria and be willing to follow the frequent treatment schedule in order to participate. Your GI physician will let you know if you are a candidate for cisapride therapy.