Shortage of Addison's Disease Drug Prompts FDA Advisory

July 25, 2018
Kerry Lengyel

Due to a shortage of Percorten-V, the FDA is advising veterinarians to use an alternate drug option to treat canine Addison’s disease.

Percorten-V (desoxycorticosterone pivalate injectable suspension) is approved for use as replacement therapy for the mineralocorticoid deficit seen in dogs with primary adrenocortical insufficiency—also known as Addison’s disease or hypoadrenocorticism. Due to a manufacturing issue, however, the market is experiencing a shortage of this drug.

In Addison’s disease, a dog’s adrenal glands do not produce enough aldosterone or cortisol, 2 key hormones that regulate important health functions.

According to the FDA, Percorten-V is considered a medically necessary drug, which means it is the FDA’s policy to work with the manufacturer to help ensure there is an adequate supply of the drug to treat the animals that need it.

Elanco, the drug’s manufacturer, explained on its website that technical challenges in the manufacturing process are being investigated with a focus on expediting resolution.

“Elanco deeply regrets that this production issue is impacting the veterinarians and pets that rely on us to manage this serious disease,” the company wrote, “and is working persistently to hurry this product back to those who need it.”

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Currently, the timeframe to resume production is unknown.

During this shortage, the FDA is advising veterinarians to prescribe an alternate FDA-approved product for their canine patients with Addison’s disease: Zycortal Suspension, manufactured by Dechra. For more information about this drug, veterinarians can visit the Dechra website.