Pfizer shut off supplies of pain drugs to veterinarians when a shortage of an injected opioid meant it couldn’t fill all of the orders it had from hospitals. But relief is now on the way for vets and their animal patients, the FDA says.
The FDA’s Center for Veterinary Medicine (CVM) says it has reached an agreement for Pfizer to divert part of a new source of the drugs for use by veterinarians.
“As a result of CVM’s recent discussion with Pfizer, this product is now available in limited quantities for pain management in animals,” the agency said. “ … Injectable opioids are used in animals to treat pain following severe trauma and to control pain during and after surgery. Adequate pain control is essential in animals, as in humans.”
The drugs will come from a supply the FDA earlier allowed (PDF) Pfizer to import from Canada. Because of the nationwide shortage, the FDA permitted the drug company to buy hydromorphone hydrochloride injection, USP, in 2 mg/ml strength, 1 ml volume ampules from Sandoz, which makes them at a plant in Canada for the Canadian market. Although the labeling is different from the same drug sold in the U.S., it is otherwise identical.
In addition to making some of this supply available to the vet market, Pfizer has also agreed to make morphine sulfate injection, USP available to the U.S. veterinary market when supply increases.
Pfizer last summer suspended sales of injected pain drugs to the veterinary market, diverting those drugs to fill orders from hospitals. It said it would be unable to resume sales for animal use until the shortage at hospitals and surgical facilities has been resolved, which it did not expect to happen before the second quarter of 2019.
The shortage of the hospital-administered pain medications, including morphine and fentanyl, started in 2017 when Pfizer reduced output of prefilled syringes as part of an upgrade at its troubled Hospira sterile drug manufacturing site in McPherson, Kansas.
Last year, Pfizer told customers that because upgrades were taking longer than expected, “full recovery dates of prioritized prefilled syringes” had moved to the first quarter of 2019 and deprioritized syringes to the second quarter of 2019.
While production has resumed, the FDA continues to find issues with the plant. An inspection in July and August resulted in eight observations, seven of them repeats. In response, Pfizer said the site developed and implemented a “robust corrective and preventive action plan” after the inspection. “While there is still additional work to be done against our plan, the site has made significant improvements and progress since the inspection.”