FDA address shortage of animal opioids by providing human drugs
December 13, 2018
The Food and Drug Administration announced it has worked with Pfizer Inc. to help alleviate a shortage of certain injectable opioids available to treat pain in animals, by facilitating the availability of a limited amount of product labeled for human use.
Most of the opioid pain medications used in veterinary medicine are approved for use in humans but also used in animals, FDA noted. This is called extra-label use, FDA said.
In September 2018, the FDA's Center for Veterinary Medicine became aware that veterinarians that had relied on these products for pain control in their patients were no longer able to obtain them through their standard distribution channels, due to a recent shortage of injectable opioids and to Pfizer's decision to restrict distribution of such products for human use only during the ongoing shortage.
The FDA had already given Pfizer permission to import Hydromorphone Hydrochloride Injection, USP, in 2 mg/ml strength, 1 ml volume ampules to help alleviate the ongoing opioid shortage in human medicine. As a result of CVM's recent discussion with Pfizer, this product is now available in limited quantities for pain management in animals.
In addition to hydromorphone, Pfizer also has made Morphine Sulfate Injection, USP, in vials and ampules available to the U.S. veterinary market. These products are in short supply but will continue to be available to veterinary practitioners when supply increases.