FDA works with Pfizer on injectable opioids for veterinary use
January 4, 2019
dvm360, dvm360 February 2019, Volume 50, Issue 2
Agency collaborates with human pharma company to keep hydromorphone, morphine available for surgical and trauma pain in animals during supply shortage.
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In mid-December, the FDA announced that it was working with Pfizer Inc. to help alleviate a shortage of certain injectable opioids for treating 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 in an extralabel capacity, the agency says in a media release.
“FDA is aware that the opioid shortage has been acutely felt in the veterinary community, just as it has in hospitals and healthcare settings providing critical care and pain management in human medicine,” the agency says in a letter to veterinarians released in December.
In September, the FDA's Center for Veterinary Medicine (CVM) became aware that veterinarians who relied on these products for pain control in their patients were no longer able to obtain them through their standard distribution channels, according to the release. This was due to a recent shortage of injectable opioids and to Pfizer's decision to restrict distribution of such products for human use during the ongoing shortage.
The CVM met with Pfizer about the veterinary community's need for injectable opioids and discussed how a limited supply imported from other countries could be made available for use in the U.S. veterinary market, the release states. The FDA had already given Pfizer permission to import injectable hydromorphone to help alleviate the shortage in human medicine. As a result, this product is now available in limited quantities for pain management in animals, the release indicates.
In addition to hydromorphone, Pfizer has also made injectable morphine available to veterinarians in the U.S., according to the release. The CVM says these products are in short supply but will continue to be available to veterinary practitioners when supply increases.
Veterinarians can purchase the products through their normal distribution chains, which have been alerted that they are now available in limited supply for the veterinary market, according to the CVM. Pfizer reports that it expects the opioid shortage to end early this year and that it will continue to keep these products available to the veterinary market in the interim.