FDA announces recall of human sedative used extralabel by veterinarians


The US Food and Drug Administration (FDA) announced a voluntary recall of a sedative commonly used in the treatment of human COVID patients due to possible lidocaine cross-contamination. The drug is also used extralabel by some veterinarians as an antianxiety drug and analgesic.

Pharmaceutical company Fresenius Kabi issued a voluntary recall of two lots of injectable Dexmedetomidine (DM) hydrochloride injection (HCI) earlier this week after discovering possible trace amounts of lidocaine in those lots.

The company said that, to date, no adverse reactions have been reported, but noted that, “Administration of DM HCl containing trace amounts of lidocaine to a patient with a lidocaine allergy . . . could result in anaphylaxis, a potentially life-threatening condition.” Some cats and dogs have an allergic reaction to lidocaine. Cats are particularly sensitive.

Injectable DM is widely used for sedation, restraint, and pain relief in veterinary medicine.

To find out the implications of the recall for veterinarians, NEWStat contacted Tamara Grubb, DVM, PhD, DACVAA, assistant clinical professor of anesthesia and analgesia at Washington State University’s College of Veterinary Medicine, and cochair of the 2020 AAHA Anesthesia and Monitoring Guidelines for Dogs and Cats.

Grubb told NEWStat that the recall is likely not a major concern: “DM comes in two different concentrations that are FDA approved for dogs and cats.” She said the only reason to use the human product is because it’s a lower concentration than the concentrations approved for animals, but, “if a veterinarian needed a lower concentration, they could simply dilute the animal-approved DM with sodium chloride (saline) to a concentration that suited their needs.”

Her advice: “Don’t use the human product when two products are FDA approved for veterinary use.”

In addition to lack of FDA approval for use in animals, she said the DM approved for humans is in short supply due to the pandemic—it’s widely used to sedate COVID patients on ventilators.

Although reminiscent of the lack of personal protective equipment available for veterinary hospitals during the early days of COVID so human hospitals could get the first crack, Grubb doesn’t think veterinarians will be asked to stop using human DM. “But if a veterinarian tried to buy it, they might be waitlisted. That’s what happened during the opioid shortage. The drug companies sold their drugs to human doctors [and] pharmacies first.”

“We’ve been impacted by many of the drugs used in human medicine that are associated with anesthesia/sedation for COVID patients,” Grubb said. “Some of the opioids are still in short supply, as are the benzodiazepines [such as midazolam and diazepam]. We can still get those drugs, but [we’re] limited in how many we can buy.”

Grubb said this is primarily happening with drugs that don’t have a veterinary-specific version, meaning we depend on human medicine for supply. “The good thing is that both propofol and ketamine, although heavily used in human medicine—especially right now—also have veterinary products specifically labeled for veterinary patients.”

She said it’s unlikely that doctors in human healthcare could use those same products, so veterinarians aren’t likely to see a shortage due to extralabel human use. But if any of the components needed to make those drugs were funneled to human medicine to make human drugs,  that could impact the ability of the veterinary drug companies to make their products.

It hasn’t happened yet, Grubb said: “But some of the companies that have those drugs are limiting the amount of the drug that each hospital can buy.”

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