Compounding Drug Causes Congestive Heart Failure

Case Overview

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.

Questions to the Pharmacology expert and their responses

Do you have experience in the pharmaceutical industry?

I have knowledge of Domperidone and the use of this drug for treating lactation and gastroparesis.

What are your initial thoughts on the case?

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. 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.

About the expert

This certified compounding pharmacist has received his training from a top pharmacy program and holds clinical and academic positions in his field at both pharmacy and medical schools. He has given invited lectures on compounding pharmacy, and has authored major publications on the topic. Furthermore, he has been in practice since 1977 and has owned a compounding-only pharmacy since 2003.