Compounding Drug Causes Congestive Heart Failure

This case involves the sale of Domperidone by a pharmacist, a drug which has not been FDA approved for sale in the US, via a compounding pharmacy. The patient’s doctor did not have an FDA experimental drug protocol license but decided to prescribe the drug for the treatment of GERD. The patient did not meet the inclusion criteria and would have specifically met exclusion criteria due to a history of heart disease and complaints of chest pain. The drug was dispensed without any precautions for usage or any black box warnings for adverse side effects. The patient initiated the Domperidone dosage but then presented to his cardiologist for severe chest pain. His emergency EKG showed a Torsade de Pointes arrhythmia. The patient was admitted to the hospital for an acute coronary syndrome that evolved into a large-scale myocardial infarction.

Question(s) For Expert Witness

1. Do you have experience in the pharmaceutical industry and what are your initial thoughts on the case?

Expert Witness Response E-005982

The new FDA drug regulations are intended to prevent the sale of unproven or dangerous drugs through traditional or compounding pharmacies. Off-label use of some drugs, however, is still permissible. I have knowledge of Domperidone and the use of this drug for treating lactation and gastroparesis. Furthermore, I am aware of the FDA warnings and, in my practice, I provide these warnings to anyone inquiring about Domperidone as an alternative drug therapy. Given the extensive line of GERD medications available, other options should have been exhausted with this patient before trying an experimental, off-label drug.