<< Natural Remedies for a Queasy Stomach

Better Sleep with Acid Reflux >>

FDA Alert: How to Obtain Domperidone

October 11, 2012 by EStella     0

On June 7, 2004, the Food and Drug Administration (FDA) warned compounding pharmacies and firms that supply domperidone for use in compounding that it is illegal to compound domperidone and issued an import alert advising FDA field personnel that they may detain shipments of finished drug products and bulk ingredients containing domperidone. These actions were the result of the Agency's concern about the potential public health risks associated with the use of domperidone by lactating women. Although FDA has determined that domperidone should not be compounded or used to enhance breast milk production in lactating women, there are some patients with severe gastrointestinal disorders, such as severe gastroparesis or severe GI motility disorders that are refractory to standard therapy, who may benefit from the drug and in whom the drug's benefits outweigh its risks.

FDA encourages physicians who would like to prescribe domperidone for their patients with severe gastrointestinal disorders that are refractory to standard therapy to open an Investigational New Drug Application (IND). An IND is a request for FDA authorization to administer an investigational drug to humans. Such authorization would allow the importation, interstate shipment, and administration of the drug even though it is not approved for sale in the U.S. For questions relating to domperidone INDs contact the Division of Drug Information, toll free at (888) INFO-FDA or (301) 796-3400.

Eligibility for Domperidone

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:
- Male or female
- Age 18 or older
- Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy.
- Subjects must have a comprehensive evaluation to eliminate other causes of their symptoms.
- Subject has signed informed consent for the administration of domperidone. The informed consent informs the subject of potential adverse events including:
o increased prolactin levels
o extrapyramidal side effects
o breast changes
o cardiac arrhythmias including QT prolongation
o there is a potential for increased risk of adverse events with the drugs listed in the addendum

Exclusion Criteria:
- History of or current cardiac disease, including ischemic or valvular heart disease, other structural heart defects, cardiomyopathy or congestive heart failure.
- History of or current arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Subjects with minor forms of ectopy (PACs) are not necessarily excluded.
- Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QT syndrome (QTc greater than 450 milliseconds for males, greater 470 milliseconds for females) or family history prolonged QT syndrome.
- Presence of a prolactinoma (prolactin-releasing pituitary tumor).
- Conditions that result in electrolyte disorders, such as severe dehydration, vomiting, malnutrition, eating disorders, renal diseases, or the use of potassium-wasting diuretics or insulin in acute settings. (Note that the presence of vomiting, that may accompany gastroparesis or pseudo- obstruction does not by itself exclude the subject - only if accompanied by electrolyte disturbance must the subject be excluded.)
- Pregnant or breast feeding female.
- Known allergy to domperidone or any components of the domperidone formulation.
- Significantly significant electrolyte disorders.
- Gastrointestinal hemorrhage or obstruction.

Filed under: FDA and Domperidone.

Tags: fda domperidone motilium.

Leave your comment:

Your email address will not be published. Required fields are marked with *.

Name (required, limit 30 characters)

Email (required, will not be published)

Your Comment

Enter Code (not case-sensitive)