Tendon issues with Fluoroquinolones

[Guest guest]

Happy New Year!

I just have to stick my 2 cents in on this topic. I don't think that

we can extrapolate from human medicine and condemn fluoroquinolones in

dogs. Additionally, both of the drugs cited are not the commonly used

fluoroquinolones in veterinary medicine. I think that until there is

hard evidence that supports discontinuing using them in dogs, we should

not make make suggestions to avoid their usage. Experience wise,

since Baytril hit the market (15 - 20 years ago?) I have not seen any

tendon injury associated with their usage, nor have I seen any tendon

injury after their usage. Does anyone on this list know of any

citation or reference addressing this human problem? By the way, I do

not work for Bayer nor am I getting paid to say this (I wish I was

though).

Mark B. Parchman, DVM, DACVS, CVA

1245 SE 3rd St.,

Suite C3 Tel

Bend, Oregon

97702 Fax

tomlinson wrote:

Hi Laurie

It is something we

always talked about when I used to treat horses,

not sure in the small animal world but I avoid them in canine athletes

Tomlinson BVSc

MS PhD DACVS CCRP

Certified Canine

Rehabilitation Practitioner

Twin Cities Animal

Rehabilitation Clinic

12010 Riverwood Dr,

Burnsville MN 55337

www.tcrehab.com

From:

VetRehab [mailto:VetRehab ]

On Behalf Of Dr.

Laurie McCauley

Sent: Friday, January 04, 2008 3:15 PM

To: VetRehab

Subject: Tendon issues with Ab'sl?

I saw this come

across another list that I belong to and was wondering if anyone had

heard

anything about it?

Group Sues FDA

for Stronger

Warnings

Jan 3, 7:16 PM

(ET)

WASHINGTON (AP) -

A consumer

group sued the Food and Drug Administration Thursday, charging the

agency is

ignoring calls for stronger warnings that Cipro and similar antibiotics

may

cause serious tendon injuries.

Labels of the

fluoroquinolone family of antibiotics - drugs that include the popular

Cipro

and Levaquin - already warn about rupture of tendons and other tendon

injuries,

but at the bottom of a list of other side effects.

The consumer

group Public

Citizen wants those warnings upgraded to the FDA's most severe type, a

so-called

black-box warning - and for patients to get pamphlets with every bottle

that

describe the risk. It argues that too few patients know they're

supposed to

quit using the drugs if they experience symptoms such as pain or

inflammation,

before the tendon actually ruptures.

Public Citizen

filed a

petition seeking the stronger warning in August 2006.

The state of

Illinois had

filed a similar petition the previous year.

The FDA is

violating its own

statutes and putting patients at risk in taking so long to settle the

issue,

Public Citizen said in the suit filed in U.S.

District Court

for the District

of Columbia.

When Public

Citizen first

filed the petition, FDA's database showed 262 reports of tendon

ruptures

between November 1997 and December 2005, along with hundreds of other

tendon

problems in users of these antibiotics. Since then, the FDA has

received an

additional 74 reports of tendon ruptures, said Public Citizen's Dr.

Sidney

Wolfe. Only a fraction of drug side effects typically are reported to

the

agency, he noted.

An FDA spokesman

said the

agency was evaluating the lawsuit and declined comment.

[Guest guest]

Dear ,

This info was given to me by my collegue who is a board vet pathologist and teaches at uni. This was the result of her correlation of the literature and I did not find anything in it to discredit the info. Perhaps it was not as well researched as I had assumed but it was quite extensive. As for my findings - they are real. There are definitely a number of the cruciate dogs I see with other sites of inflammation. I never looked for inflammation anywhere else in the body before reading this info from my collegue and would only address the biomechanics (with success). However I have found it interesting to note other findings , regard the dog as a whole and attempt to address them as part of the whole animal.

Dr Toni Lynch BVSc Hons GDAnimal Chiro

RE: Tendon issues with Fluoroquinolones

Hi All,

If we come up with a survey, Clean run may be willing to put it up on their website. Clean run is “the” magazine company for agility people. This way we could reach a large percentage of canine athlete owners.

I am not a researcher so I would need some help. What I was thinking was to ask people:

Has your athlete torn his or her cruciate?

Was your athlete on any medication just prior to or when this happened?

If yes, was an antibiotic or NSAID? (this way people will not freak out thinking ab’s are going to cause cruciate damage?????)

If your dog has torn their cruciate and was on or recently on an antibiotic, which antibiotic (list 10 or more)

Maybe a similar question with NSAIDs

Again, any thoughts/help or letting me know this would mot be a good thing to do would be appreciated J

Laurie McCauley, DVM

TOPS Veterinary Rehabilitation

Grayslake, IL

drmctops-vet-rehab

www.tops-vet-rehab.com

From: VetRehab [mailto:VetRehab ] On Behalf Of dogptSent: Saturday, January 05, 2008 8:14 PMTo: VetRehab Subject: Re: Tendon issues with Fluoroquinolones

Mark,

Quinolone induced tendon ruptures have been described in the literature dating back to the early and mid 80's. A medline search will reveal many cited references. These cases are rare, although I have treated one patient with an achilles tendon rupture and had a co-worker rupture both achilles tendons while on quinolones. I have not heard this mentioned occuring in the canine population, however, much of the phase I and II studies were performed on dogs.

Ria Acciani MPT

Acciani PT

Advanced Canine Rehabilitation

6 Kenquit Road

Happy New Year!I just have to stick my 2 cents in on this topic. I don't think that we can extrapolate from human medicine and condemn fluoroquinolones in dogs. Additionally, both of the drugs cited are not the commonly used fluoroquinolones in veterinary medicine. I think that until there is hard evidence that supports discontinuing using them in dogs, we should not make make suggestions to avoid their usage. Experience wise, since Baytril hit the market (15 - 20 years ago?) I have not seen any tendon injury associated with their usage, nor have I seen any tendon injury after their usage. Does anyone on this list know of any citation or reference addressing this human problem? By the way, I do not work for Bayer nor am I getting paid to say this (I wish I was though). Mark B. Parchman, DVM, DACVS, CVA

<clip_image002.gif>

1245 SE 3rd St., Suite C3 Tel Bend, Oregon 97702 Fax tomlinson wrote:

Hi Laurie

It is something we always talked about when I used to treat horses, not sure in the small animal world but I avoid them in canine athletes

Tomlinson BVSc MS PhD DACVS CCRP

Certified Canine Rehabilitation Practitioner

Twin Cities Animal Rehabilitation Clinic

12010 Riverwood Dr, Burnsville MN 55337

www.tcrehab.com

<mime-attachment.jpeg>

From: VetRehab [mailto:VetRehab ] On Behalf Of Dr. Laurie McCauleySent: Friday, January 04, 2008 3:15 PMTo: VetRehab Subject: Tendon issues with Ab'sl?

I saw this come across another list that I belong to and was wondering if anyone had heard anything about it?

Group Sues FDA for Stronger Warnings

Jan 3, 7:16 PM (ET)

WASHINGTON (AP) - A consumer group sued the Food and Drug Administration Thursday, charging the agency is ignoring calls for stronger warnings that Cipro and similar antibiotics may cause serious tendon injuries.

Labels of the fluoroquinolone family of antibiotics - drugs that include the popular Cipro and Levaquin - already warn about rupture of tendons and other tendon injuries, but at the bottom of a list of other side effects.

The consumer group Public Citizen wants those warnings upgraded to the FDA's most severe type, a so-called black-box warning - and for patients to get pamphlets with every bottle that describe the risk. It argues that too few patients know they're supposed to quit using the drugs if they experience symptoms such as pain or inflammation, before the tendon actually ruptures.

Public Citizen filed a petition seeking the stronger warning in August 2006.

The state of Illinois had filed a similar petition the previous year.

The FDA is violating its own statutes and putting patients at risk in taking so long to settle the issue, Public Citizen said in the suit filed in U.S.

District Court for the District of Columbia.

When Public Citizen first filed the petition, FDA's database showed 262 reports of tendon ruptures between November 1997 and December 2005, along with hundreds of other tendon problems in users of these antibiotics. Since then, the FDA has received an additional 74 reports of tendon ruptures, said Public Citizen's Dr. Sidney Wolfe. Only a fraction of drug side effects typically are reported to the agency, he noted.

An FDA spokesman said the agency was evaluating the lawsuit and declined comment.

Warren, NJ 07059

[Guest guest]

Hi, Not to be a naysayer, but...... I do agree that we need more information about cruciate disease/rupture but I am concerned that a survey for the average dog owner (even the more sophisticated sporting dog types) could lead to more headaches and no clear answers. We do not need to put anymore questionable information out there for the public to take as fact. There are so many variables to consider when looking at something as prevelant as cruciate rupture like breed, body condition score, concurrent disease, etc. What about doing a retrospective of cruciate repairs from Universities or referral clinics to see if it is even statistally significant that dogs on medication (or antibiotics) rupture their cruciates? Both cruciate rupture and the use of fluroquinolones are common events, it could be relatively easy to make a false link between the two. We desperately need

to move away from cause and effect thinking. I really support exploring the questions but I think this question is too big and too easy to misconstrue the results. A. Roos DVM"Dr. Laurie McCauley" wrote: Hi All, If we come up with a survey, Clean run may be willing to put it up on their website. Clean run is “the” magazine company for agility people. This way we could reach a large percentage of canine athlete owners. I am not a researcher so I would need some help. What I was thinking was to ask people: Has your athlete torn his or her cruciate? Was your athlete on any medication just prior to or when this happened? If yes, was an antibiotic or NSAID? (this way people will not freak out thinking ab’s are going to cause cruciate damage?????) If your dog has torn their cruciate and was on or recently on an antibiotic, which antibiotic (list 10 or more) Maybe a similar question with NSAIDs Again, any thoughts/help or letting me know this would mot be a good thing to do

would be appreciated J Laurie McCauley, DVM TOPS Veterinary Rehabilitation Grayslake, IL drmctops-vet-rehab www.tops-vet-rehab.com From: VetRehab

[mailto:VetRehab ] On Behalf Of dogptSent: Saturday, January 05, 2008 8:14 PMTo: VetRehab Subject: Re: Tendon issues with Fluoroquinolones Mark, Quinolone induced tendon ruptures have been described in the literature dating back to the early and mid 80's. A medline search will reveal many cited references. These

cases are rare, although I have treated one patient with an achilles tendon rupture and had a co-worker rupture both achilles tendons while on quinolones. I have not heard this mentioned occuring in the canine population, however, much of the phase I and II studies were performed on dogs. Ria Acciani MPT Acciani PT Advanced Canine

Rehabilitation 6 Kenquit Road Happy New Year!I just have to stick my 2 cents in on this topic. I don't think that we can extrapolate from human

medicine and condemn fluoroquinolones in dogs. Additionally, both of the drugs cited are not the commonly used fluoroquinolones in veterinary medicine. I think that until there is hard evidence that supports discontinuing using them in dogs, we should not make make suggestions to avoid their usage. Experience wise, since Baytril hit the market (15 - 20 years ago?) I have not seen any tendon injury associated with their usage, nor have I seen any tendon injury after their usage. Does anyone on this list know of any citation or reference addressing this human problem? By the way, I do not work for Bayer nor am I getting paid to say this (I wish I was though). Mark B. Parchman, DVM, DACVS, CVA <clip_image002.gif> 1245 SE 3rd St., Suite C3 Tel Bend, Oregon 97702 Fax tomlinson wrote: Hi Laurie It is something we always talked about when I used to treat horses, not sure in the small animal world but I avoid them in canine athletes Tomlinson BVSc MS PhD DACVS CCRP Certified Canine Rehabilitation Practitioner Twin Cities Animal Rehabilitation Clinic 12010 Riverwood Dr, Burnsville MN 55337 www.tcrehab.com <mime-attachment.jpeg> From: VetRehab [mailto:VetRehab ] On Behalf Of Dr. Laurie McCauleySent: Friday, January 04, 2008 3:15 PMTo: VetRehab Subject: Tendon issues with Ab'sl? I saw this come across another list that I belong to and was wondering if anyone had heard anything about it? Group Sues FDA for Stronger Warnings Jan 3, 7:16 PM (ET) WASHINGTON (AP) - A consumer group sued the Food and Drug Administration Thursday, charging the agency is ignoring calls for stronger warnings that Cipro and similar antibiotics may cause serious tendon injuries. Labels of the fluoroquinolone family of antibiotics - drugs that include the popular Cipro and Levaquin - already warn about rupture of tendons and other tendon injuries, but at the bottom of a list of other side effects. The consumer group Public Citizen wants those warnings upgraded to the FDA's most severe type, a so-called black-box warning - and for patients to

get pamphlets with every bottle that describe the risk. It argues that too few patients know they're supposed to quit using the drugs if they experience symptoms such as pain or inflammation, before the tendon actually ruptures. Public Citizen filed a petition seeking the stronger warning in August 2006. The state of Illinois had filed a similar petition the previous year. The FDA is violating its own statutes and putting patients at risk in taking so long to settle the issue, Public Citizen said in the suit filed in

U.S. District Court for the District of Columbia. When Public Citizen first filed the petition, FDA's database showed 262 reports of tendon ruptures between November 1997 and December 2005, along with hundreds of other tendon problems in users of these antibiotics. Since then, the FDA has received an additional 74 reports of tendon ruptures, said Public Citizen's Dr. Sidney Wolfe. Only a fraction of drug side effects typically are reported to the agency, he noted. An FDA spokesman said the

agency was evaluating the lawsuit and declined comment. Warren, NJ 07059

Be a better friend, newshound, and know-it-all with Yahoo! Mobile. Try it now.

[Guest guest]

Hi Laurie,Just a few comments regarding a possible survey.If the risk factor occurs in tendons, why would we ask about a ligament tear?These tissues are quite different.  The tendon ruptures occur usually 2-3 cm above a poorly vascularized area- most commonly the achilles tendon, but has also occurred in the shoulder and hand.Also, while the agility clientele are great for keeping records and love to give information, I'm not sure this group is most representative of the ccl tears that we see.  In our experience, we see much more "pets" with ccl tears than performance dogs.On a side note:If I recall, tendon tissue exposed to ciprofloxacin showed a significant decrease in fibroblastic proliferation and collagen synthesis.  Tendon ruptures have been reported to have occurred as early as a few hours after the initial dose, or up to 6 months after drug therapy- this makes it very difficult to prove a direct correlation.Ria Acciani MPT Acciani PTAdvanced Canine Rehabilitation6 Kenquit RoadWarren, NJ 07059Hi All,If we come up with a survey, Clean run may be willing to put it up on their website. Clean run is “the” magazine company for agility people.  This way we could reach a large percentage of canine athlete owners.I am not a researcher so I would need some help.  What I was thinking was to ask people:Has your athlete torn his or her cruciate?Was your athlete on any medication just prior to or when this happened?If yes, was an antibiotic or NSAID?  (this way people will not freak out thinking ab’s are going to cause cruciate damage?????)If your dog has torn their cruciate and was on or recently on an antibiotic, which antibiotic (list 10 or more)Maybe a similar question with NSAIDs Again, any thoughts/help or letting me know this would mot be a good thing to do would be appreciated J Laurie McCauley, DVMTOPS Veterinary RehabilitationGrayslake, ILdrmctops-vet-rehabwww.tops-vet-rehab.com  From: VetRehab [mailto:VetRehab ] On Behalf Of dogptSent: Saturday, January 05, 2008 8:14 PMTo: VetRehab Subject: Re: Tendon issues with Fluoroquinolones Mark,Quinolone induced tendon ruptures have been described in the literature dating back to the early and mid 80's. A medline search will reveal many cited references. These cases are rare, although I have treated one patient with an achilles tendon rupture and had a co-worker rupture both achilles tendons while on quinolones. I have not heard this mentioned occuring in the canine population, however, much of the phase I and II studies were performed on dogs. Ria Acciani MPT Acciani PTAdvanced Canine Rehabilitation6 Kenquit Road  Happy New Year!I just have to stick my 2 cents in on this topic. I don't think that we can extrapolate from human medicine and condemn fluoroquinolones in dogs. Additionally, both of the drugs cited are not the commonly used fluoroquinolones in veterinary medicine. I think that until there is hard evidence that supports discontinuing using them in dogs, we should not make make suggestions to avoid their usage. Experience wise, since Baytril hit the market (15 - 20 years ago?) I have not seen any tendon injury associated with their usage, nor have I seen any tendon injury after their usage. Does anyone on this list know of any citation or reference addressing this human problem? By the way, I do not work for Bayer nor am I getting paid to say this (I wish I was though). Mark B. Parchman, DVM, DACVS, CVA<clip_image002.gif>1245 SE 3rd St., Suite C3 Tel Bend, Oregon 97702 Fax tomlinson wrote: Hi LaurieIt is something we always talked about when I used to treat horses, not sure in the small animal world but I avoid them in canine athletes Tomlinson BVSc MS PhD DACVS CCRPCertified Canine Rehabilitation PractitionerTwin Cities Animal Rehabilitation Clinic12010 Riverwood Dr, Burnsville MN 55337www.tcrehab.com<mime-attachment.jpeg>From: VetRehab [mailto:VetRehab ] On Behalf Of Dr. Laurie McCauleySent: Friday, January 04, 2008 3:15 PMTo: VetRehab Subject: Tendon issues with Ab'sl?I saw this come across another list that I belong to and was wondering if anyone had heard anything about it?Group Sues FDA for Stronger WarningsJan 3, 7:16 PM (ET)WASHINGTON (AP) - A consumer group sued the Food and Drug Administration Thursday, charging the agency is ignoring calls for stronger warnings that Cipro and similar antibiotics may cause serious tendon injuries.Labels of the fluoroquinolone family of antibiotics - drugs that include the popular Cipro and Levaquin - already warn about rupture of tendons and other tendon injuries, but at the bottom of a list of other side effects.The consumer group Public Citizen wants those warnings upgraded to the FDA's most severe type, a so-called black-box warning - and for patients to get pamphlets with every bottle that describe the risk. It argues that too few patients know they're supposed to quit using the drugs if they experience symptoms such as pain or inflammation, before the tendon actually ruptures.Public Citizen filed a petition seeking the stronger warning in August 2006.The state of Illinois had filed a similar petition the previous year.The FDA is violating its own statutes and putting patients at risk in taking so long to settle the issue, Public Citizen said in the suit filed in U.S.District Court for the District of Columbia.When Public Citizen first filed the petition, FDA's database showed 262 reports of tendon ruptures between November 1997 and December 2005, along with hundreds of other tendon problems in users of these antibiotics. Since then, the FDA has received an additional 74 reports of tendon ruptures, said Public Citizen's Dr. Sidney Wolfe. Only a fraction of drug side effects typically are reported to the agency, he noted.An FDA spokesman said the agency was evaluating the lawsuit and declined comment. Warren, NJ 07059  

[Guest guest]

Hi All,

It sounds like the survey would not be a

good idea. This is why having a group like this is so wonderful, we can

throw out ideas and get many opinions before doing something that may or may

not be valuable. As I said before research is not my area of

expertise.

Thank you to all who have added to this

discussion,

Laurie

Laurie McCauley, DVM

TOPS Veterinary

Rehabilitation

Grayslake,

IL

drmc@...

www.tops-vet-rehab.com

From: VetRehab [mailto:VetRehab ] On Behalf Of dogpt

Sent: Thursday, January 10, 2008

10:05 AM

To: VetRehab

Subject: Re: Tendon

issues with Fluoroquinolones

Hi

Laurie,

Just a few comments regarding a possible survey.

If the risk factor occurs in tendons, why would we ask about a ligament

tear?

These tissues are quite different. The tendon ruptures occur

usually 2-3 cm above a poorly vascularized area- most commonly the achilles

tendon, but has also occurred in the shoulder and hand.

Also, while the agility clientele are great for keeping records and

love to give information, I'm not sure this group is most representative of the

ccl tears that we see. In our experience, we see much more

" pets " with ccl tears than performance dogs.

On a side note:

If I recall, tendon tissue exposed to ciprofloxacin showed a

significant decrease in fibroblastic proliferation and collagen

synthesis. Tendon ruptures have been reported to have occurred as early

as a few hours after the initial dose, or up to 6 months after drug therapy-

this makes it very difficult to prove a direct correlation.

Ria Acciani MPT

Acciani PT

Advanced Canine Rehabilitation

6 Kenquit Road

Warren,

NJ 07059

Hi All,

If we come up with a

survey, Clean run may be willing to put it up on their website. Clean run is

“the” magazine company for agility people. This way we could

reach a large percentage of canine athlete owners.

I am not a researcher so

I would need some help. What I was thinking was to ask people:

Has your athlete torn his

or her cruciate?

Was your athlete on any

medication just prior to or when this happened?

If yes, was an antibiotic

or NSAID? (this way people will not freak out thinking ab’s are

going to cause cruciate damage?????)

If your dog has torn

their cruciate and was on or recently on an antibiotic, which antibiotic (list

10 or more)

Maybe a similar question

with NSAIDs

Again, any thoughts/help

or letting me know this would mot be a good thing to do would be appreciated J

Laurie

McCauley, DVM

TOPS

Veterinary Rehabilitation

Grayslake, IL

drmctops-vet-rehab

www.tops-vet-rehab.com

From: VetRehab

[mailto:VetRehab ]

On Behalf Of dogpt

Sent:

Saturday, January 05, 2008 8:14 PM

To: VetRehab

Subject:

Re: Tendon issues with Fluoroquinolones

Mark,

Quinolone induced tendon ruptures have

been described in the literature dating back to the early and mid 80's. A

medline search will reveal many cited references. These cases are rare,

although I have treated one patient with an achilles tendon rupture and had a

co-worker rupture both achilles tendons while on quinolones. I have not heard

this mentioned occuring in the canine population, however, much of the phase I

and II studies were performed on dogs.

Ria Acciani MPT

Acciani PT

Advanced Canine Rehabilitation

6

Kenquit Road

On Jan 5, 2008, at 6:36 PM, Mark B.

Parchman wrote:

Happy New Year!

I just have to stick my 2 cents in on this topic.

I don't think that we can extrapolate from human medicine and condemn

fluoroquinolones in dogs. Additionally, both of the drugs cited are not the

commonly used fluoroquinolones in veterinary medicine. I think that until there

is hard evidence that supports discontinuing using them in dogs, we should not

make make suggestions to avoid their usage. Experience wise, since Baytril hit

the market (15 - 20 years ago?) I have not seen any tendon injury associated

with their usage, nor have I seen any tendon injury after their usage. Does

anyone on this list know of any citation or reference addressing this human

problem? By the way, I do not work for Bayer nor am I getting paid to say this

(I wish I was though).

Mark B. Parchman, DVM, DACVS, CVA

<clip_image002.gif>

1245 SE 3rd St., Suite C3 Tel

Bend, Oregon 97702 Fax

tomlinson wrote:

Hi Laurie

It is something we always talked about

when I used to treat horses, not sure in the small animal world but I avoid

them in canine athletes

Tomlinson BVSc MS PhD DACVS CCRP

Certified Canine Rehabilitation

Practitioner

Twin Cities Animal Rehabilitation Clinic

12010 Riverwood Dr, Burnsville MN 55337

www.tcrehab.com

<mime-attachment.jpeg>

From: VetRehab

[mailto:VetRehab ] On Behalf Of Dr. Laurie McCauley

Sent:

Friday, January 04, 2008 3:15 PM

To: VetRehab

Subject:

Tendon issues with Ab'sl?

I saw this come across another list that I

belong to and was wondering if anyone had heard anything about it?

Group Sues

FDA for Stronger Warnings

Jan 3, 7:16

PM (ET)

WASHINGTON (AP) - A consumer group sued the Food and Drug

Administration Thursday, charging the agency is ignoring calls for stronger

warnings that Cipro and similar antibiotics may cause serious tendon injuries.

Labels of the fluoroquinolone family of antibiotics - drugs

that include the popular Cipro and Levaquin - already warn about rupture of

tendons and other tendon injuries, but at the bottom of a list of other side

effects.

The consumer group Public Citizen wants those warnings

upgraded to the FDA's most severe type, a so-called black-box warning - and for

patients to get pamphlets with every bottle that describe the risk. It argues

that too few patients know they're supposed to quit using the drugs if they

experience symptoms such as pain or inflammation, before the tendon actually

ruptures.

Public Citizen filed a petition seeking the stronger

warning in August 2006.

The state of Illinois had

filed a similar petition the previous year.

The FDA is violating its own statutes and putting patients

at risk in taking so long to settle the issue, Public Citizen said in the suit

filed in U.S.

District

Court for the District of Columbia.

When Public Citizen first filed the petition, FDA's

database showed 262 reports of tendon ruptures between November 1997 and

December 2005, along with hundreds of other tendon problems in users of these

antibiotics. Since then, the FDA has received an additional 74 reports of

tendon ruptures, said Public Citizen's Dr. Sidney Wolfe. Only a fraction of

drug side effects typically are reported to the agency, he noted.

An FDA spokesman said the agency was evaluating the lawsuit

and declined comment.

Warren, NJ 07059