I write this in memory of my cat Gypsy, who died needlessly after treatment for a minor injury.  She suffered acute kidney failure following “Metacam” oral dosing. 

I have tremendous guilt not having researched this drug thoroughly before its administration.  If publishing this editorial can save the lives of other cats, Gypsy’s death will not have been in vain..
Metacam (Meloxicam) is a non-steroidal anti-inflammatory for dogs, farm animals and cats.
Cats are approved for a one-time subcutaneous injection only (no oral dosing).

 

 

An FDA study (Adverse Drug Experience Report 2006) shows approximately a 32% acute kidney failure in cats that are orally dosed.  Other side effects are: vomiting, diarrhea, lethargy, decreased appetite and depression. 

The drug company Boehringer Ingelheim is not responsible for misuse. The cat package insert (which I did not receive) states:
Cats: a single one-time subcutaneous dose, NOT to be followed by a second dose of Metacam or any other NSAIDs. (Non-steroidal anti-inflammatory) Metacam has a very Low Safety Margin, meaning there is little difference between a safe dose and one that is toxic. Small animals are particularly vulnerable, especially cats who are very sensitive to drugs.  Oral dosing is very dangerous!
There are few drugs available for cats, so I do empathize with the drug choice dilemma.  Nevertheless, the veterinarian must have comprehensive and current data regarding the drugs they choose to use, weighing the risks and benefits.

The problem starts with “Off-label Use” a practice in both human and veterinary medicine. The practitioner prescribes drugs for a purpose outside the scope of the drug’s approved label, however prescribing against “specific label directions” puts them on a very slippery slope.  This is especially true with no informed consent!

Be your pet’s advocate and ask:

1. Are my cat’s liver and kidney blood tests acceptable?
2. May I have copies of the drug product sheets?
3. What are serious side effects of this drug?
4. My pet weighs less than 10 lbs…is this safe?
5. Is this drug FDA approved?   If not…why?
6. What other drugs are approved?
7. Do the benefits outweigh the risks?

Metacam is justifiably not approved in Canada or the USA for oral dosing of cats.

Gypsy was privately cremated June 16, 2008 at Hazelwood Acres,  Thunder Bay.

Submitted by:
A. Bishop

 

Background

Metacam & Cats

This article discusses six frequently heard statements regarding the use of Metacam in cats.
Taken as a set, these statements paint a very positive picture. However, when each statement is individually scrutinized, many interesting truths emerge.

#1     “Metacam is approved for cats”

Metacam is marketed worldwide in three forms (injectable solution, oral suspension, and chewable tablets) and for five target species (dogs, cats, horses, cattle, and pigs). So the country issuing the approvals and the forms and target species covered by those approvals must accompany any general statements about its approval status. The following table shows the approval dates for dogs and cats in the United States.


FDA Approval Dates

Target Species Drug Form……….dogs & cats
Injectable (NADA 141-219) 12 Nov 2003 28 Nov 2004
Oral suspension (NADA 141-213) 15 Apr 2003 not approved
Note that the FDA approval for cats is limited to onetime use of the injectable form; subsequent oral dosing is specifically contraindicated. [1]
The FDA grants a five-year marketing exclusivity period for new animal drugs; Metacam Oral’s exclusivity expires on 15 April 2008, at which time generic versions will become available in the USA.

#2    “Metacam has been used for 10 years in Europe”

Again, we need to disambiguate this statement with more specific information from the European Medicines Agency.[2]
EMEA Approval Dates Target Species Drug Form dogs/ cats
Injectable EU/2/97/004/006 10 Nov 1999 09 Aug 2002
 Oral susp EU/2/97/004/003 07 Jan 1998 not approved
Now we see that European approval in cats (again, for one-time injection only) is much more recent.
Note also that Novopharm UK has recently (April 2006) received EMEA approval for the generic version Flexicam Oral.[3]

 #3    “35 million doses of Metacam have been sold”

This may indeed be true, but this is likely a worldwide aggregate figure and the vast majority of these doses have been for use in dogs and farm animals.

It’s better to ask more specific and relevant questions such as “How many doses of Metacam Injection for Cats have been sold in the USA?” or “How many doses of Metacam Oral have been sold for cats in this country?”

#4   “Metacam has an unparalleled safety record”

This may indeed be true for dogs; the target animal safety studies[4] filed with the FDA show that dogs can tolerate single 120X doses (where 1X = 0.1 mg/ml) and repeated daily 5X doses for six months with no deaths. However, when four cats were given repeated daily 3X doses for eight days, one died and another was moribund.[5] It is therefore clear that Metacam’s safety in dogs cannot be extrapolated to cats. 
  
FDA’s Adverse Drug Experience Summaries (6)

Meloxicam in Cats, Route:  Oral  
Parenteral
No. of animals evaluated:  328  71


Clinical Sign   
Anorexia  152  34
BUN high (blood)  145  38
Creatinine high (blood)  143  37
Depression/lethargy 135  31
Kidney failure  105  17
Vomiting  102  25
Azotemia  55  15
Death  52  16
Phosphorous high (blood)  51  15
Death (euthanized)  37  9
Dehydration  33  8
Weight loss  29  4
Diarrhea  25  1

#5    “Deaths in cats are idiosyncratic”

Idiosyncratic refers to an unusual drug reaction that is particular to an individual or group. Since there are no adequate field trials for Metacam in cats, there is no data to define “usual” reactions. It is therefore impossible to determine whether the death of any particular cat is idiosyncratic or not.

#6   “There’s nothing wrong with off-label use”

Off-label drug use is a widespread practice in both human and veterinary medicine; however, prescribing directly against label directions (i.e. do not use in cats) is not common.
Recent jurisprudence (Richardson vs. Miller[7]) in the field of human medicine shows that the practitioner is exposed to significant legal liability when ignoring label contraindications, and particularly so when informed consent is not given!

Off-label prescription of Metacam for cats is especially problematic in Canada, where other NSAIDs (ketoprofen and tolfenamic acid) have approved labeling for short-term repeated use in cats. 
This makes Metacam difficult to justify!

References:

[1] Product sheet: Metacam Solution for Injection for Cats Boehringer Ingelheim Vetmedica, Inc. (revised October 2004)
http://www.bi-vetmedica.com/.../Metacam_Cat_RP.pdf

[2] Metacam European Public Assessment Report
http://www.emea.eu.int/vetdocs/vets/Epar/metacam/metacamM.htm

[3] Flexicam European Public Assessment Report
http://www.emea.eu.int/vetdocs/vets/Epar/flexicam/flexicam.
htm
[4] Freedom of Information Summary for NADA 141-213 (Metacam Oral)
 
http://www.fda.gov/cvm/FOI/141-213.pdf

[5] Freedom of Information Summary for Supplemental NADA 141-219 (Metacam 5 mg/ml Solution for Injection for Cats (28 October 2004)
http://www.fda.gov/cvm/FOI/141-219s102804.pdf

[6] FDA Adverse Drug Experiences Report (10 July 2006)
http://www.fda.gov/cvm/Documents/ade_web_rpts_MN.pdf

[7] Off-Label Prescribing, Maxwell J. Mehlman, J.D. 
http://www.thedoctorwillseeyounow.com

Information from the Manufacturer About Metacam