Efforts to keep cisapride available meet dead end
Regulatory restrictions have prevented the AVMA from keeping open the channels of veterinary access to a human drug effective in treating megacolon in cats.
The only US manufacturer of the drug cisapride had announced March 23 it would voluntarily stop marketing the approved human-labeled drug July 14 of this year. Use of the drug has been associated with reports of human heart rhythm abnormalities, usually in patients taking other medications or suffering from underlying conditions known to increase risk of cardiac arrhythmia associated with cisapride.
Limited access to the drug is still provided for human patients for whom other therapies are not effective and who meet clinical eligibility criteria. Knowing that, the AVMA encouraged the company to explore the possibility of continuing to provide cisapride to veterinarians for its unique use in cats. The American Association of Feline Practitioners, Academy of Feline Medicine, and AVMA worked together to gather information to share with the manufacturer on the importance of this drug.
The company gave the issue due consideration but concluded there is no legal means to involve animals. The pathway for the limited access program for humans is an investigational drug approach. The company does not have investigational exemption for animal drugs and has no animal drug division in the United States.