FDA Warning: Some Epilepsy Treatment Drugs are Mislabeled

photo 2006 Amayzun | more info (via: Wylio)I recently received an urgent E-mail notification from the American Veterinary Medical Association. It seems that Qualitest Pharmaceuticals,...

Dr. Eric Barchas  |  Mar 13th 2011


12/14/2006 - Pillz (ViCoDiN) #4696a.jpgphoto 2006 Amayzun | more info (via: Wylio)
I recently received an urgent E-mail notification from the American Veterinary Medical Association. It seems that Qualitest Pharmaceuticals, a manufacturer that supplies some veterinary products, has made a production error. It has distributed generic Vicodins in pills that for all outward appearances appear to be (and are labeled as) phenobarbital.

Phenobarbital is used to treat epilepsy and seizures in dogs and cats. It also may be used as a sedative. Vicodin is used to treat pain in humans. One of Vicodin’s ingredients, acetaminophen, is deadly poisonous to cats. In dogs the safety margin of acetaminophen is low. Animals that receive the mislabeled pills could be at risk of seizures (from lack of appropriate phenobarbital treatment) as well as liver failure and death from acetaminophen.

From the alert:

March 10, 2011 — Today, the U.S. Food and Drug Administration (FDA) issued a warning to veterinarians about the possibility that tablets produced and labeled by Qualitest Pharmaceuticals as phenobarbital may actually be hydrocodone tartrate and acetaminophen tablets.

The company issued a recall of the phenobarbital tablets on February 5, 2011, but the FDA reports that it has recently received reports of severe adverse events associated with the administration of the mislabeled product to pets.

The affected products are Phenobarbital tablets, USP, 32.4 mg, NDC 0603-5166-32 in 1000-count bottles. Affected lot numbers are T150G10B, T120J10E and T023M10A. (The lot numbers are printed on the side of the bottle).

Contact your veterinarian immediately about this matter if your pet takes phenobarbital for seizures or for sedation.