* U.S. FDA has recalled large amounts of phenobarbital, for Veterinarians

* U.S. FDA has recalled large amounts of phenobarbital, a common


anti-seizure drug used by veterinarians, upon discovery that the pills are

acetaminophen.

Today in a press release by the American Veterinary Medical Association to

veterinary members, at 3:45 this afternoon, the U.S. Food and Drug

Administration (FDA) announced that a large amount of the common

anticonvulsant phenobarbital produced by the Qualitest Pharmaceuticals are

actually mislabeled acetaminophen and hydrocodone. This is a common drug

prescribed for veterinary patients who suffer from seizure disorders such as

epilepsy. The company announced a voluntary recall of the Phenobarbital

tablets on February 5th, 2011, and the FDA has recently received reports of

severe adverse events associated with administration of mislabeled product

to pets.

In addition, Phenobarbital is actually produced as a human drug that is

commonly used in veterinary medicine, but this recall also affects people on

the medication as well. According to the FDA's prior press

release< http://www.fda.gov/Safety/Recalls/ucm242398.htm>,

the following information is given for human medical advice, "As a result of

this mix-up patients may unintentionally take Hydrocodone and acetaminophen

instead of Phenobarbital. ... Hydrocodone can lead to serious adverse

effects including respiratory depression, CNS depression, coma and death...

Unintentional administration of acetaminophen may result in liver toxicity

in patients on other acetaminophen containing medications, patients with

liver dysfunction, or people who consume more than 3 alcoholic beverages a

day. Additionally, missing doses of Phenobarbital could result in loss of

seizure control."

Possible Complications From Phenobarbital Recall for Patients Receiving

Wrong Medication

Two concerns arise from this situation for owners, patients, and prescribing

veterinarians. First, breakthrough seizures and uncontrolled neurologic

symptoms may begin to emerge in patients with a prior history of well

controlled signs in the past as a result of decreasing phenobarbital levels

in the bloodstream.


Read more at Suite101: Mislabeled Phenobarbital Drug Recall: Seizure

Patients at Risk< http://www.suite101.com/content/mislabeled-phenobarbital-drug-recall-seizure-patients-at-risk-a357744#ixzz1GJQHKs87 >

http://*%20u.s.%20fda%20has%20recalled%20large%20amounts%20of%20phenobarbital,%20a%20common/

*
In addition, adverse effects related to exposure to acetaminophen as a

non-steroidal anti inflammatory while owners are unaware greatly increases

the risk of co-treating with other similar common veterinary-use NSAIDS for

managing arthritis such as Rimadyl, Previcox, Deramaxx, and Metacam. This

greatly increases the potential for adverse drug reactions related to this

class of drug including gastrointestinal ulceration, liver toxicity, and

kidney failure.

What Phenobarbital Drugs Are Affected?

The affected tablets 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 can be found on the side of the

bottle.

The recalled lots were distributed between *September 21, 2010* and *December

29, 2010*, to wholesale and retail pharmacies nationwide, including Puerto

Rico.


If an owner has discovered to possess any of the affected lots in stock,

discontinue the product immediately and contact *Qualitest *at*1-800-444-4011

* for reimbursement. In addition, if any patients have experienced adverse

effects from these products, medical providers should report the events to

the *FDA’s MedWatch Safety Information and Adverse Event Reporting

Program*< http://www.fda.gov/MedWatch/report.htm>via their online

reporting system or by calling

*1-800-332-1088* for a reporting form which can be completed and return to

the address on the pre-addressed form, or submit a fax to *1-800-FDA-0178*.

Additional Information For Owners Suspicious Their Pet's Medication Is

Mislabeled


According to today's information by *Veterinary Practice

News< http://www.veterinarypracticenews.com/vet-breaking-news/2011/03/10/label-mix-up-prompts-recall-of-human-drug-prescribed-for-animals-extralabel.aspx >

,* "Qualitest Pharmaceuticals, a wholly owned subsidiary of Endo

Pharmaceuticals, gave descriptions of each drug: Hydrocodone Bitartrate and

Acetaminophen Tablets are large (about 16.5 mm in length), pink,

capsule-shaped tablets, debossed (3600) on one side and debossed (V) on the

reverse side. Phenobarbital Tablets are small (about 6.4 mm in diameter),

white, round, biconvex, scored tablets, debossed (5012) and (V) on one side

and plain on the reverse side."



Owners should immediately consult their regular veterinarian if suspicion of

exposure has occurred, avoid additional NSAID anti-inflammatory drugs listed

above, and begin to administer genuine Phenobarbital tablets immediately to

avoid a breakthrough in seizure management. If seizures occur, additional

therapies may be given to assist control while rebalancing blood levels. If

preexisting liver or kidney disease is already known, rechecking blood work

to monitor current health may be a good consideration.