ADVERSE EFFECTS from pet products Forum

Jean

Aug 9, 03 - 10:17 PM

Proheart 6

You may want to consider alternatives to heartworm prevention. I encourage you to PLEASE do your research on ProHeart 6, a drug that some suspect is causing adverse, sometimes fatal effects in SOME dogs of all breeds and ages.

I fear many vets are in the dark about what is happening to the dogs and might be choosing to ignore what they hear or see for themselves firsthand. I speak from experience. Two of my three healthy dogs died, in my opinion, after they received this shot, and my third dog remains on medications to hopefully one day restore his immune system to normal.

Christine Wyndham-Thomas

Mar 2nd, 2004 - 11:02 AM

Re: Proheart 6

On local CBS News tonight:

Joanne Plumber's dog April was injected with ProHeart 6. 3 weeks
later April had to be put to sleep. Within a few weeks, Joanne's
dog Kuji died due to complete kidney failure (3 months after she got
her ProHeart 6 shot).

FDA say there have been more than 4,000 reports of dogs getting sick
after getting a shot of ProHeart 6. 400 dogs have died. FDA says
this is a "cause for concern."

FDA has told Proheart 6 manufacturer Fort Dodge to add "there have
been rare reports of death" to the label.

Dr. Bob Rogers interviewed - he believes ProHeart 6 harms more than
it helps. "I have seen vet meds pulled off the market for less
deaths than this."

Fort Dodge says that millions of U.S. dogs have benefited from
ProHeart6.

Also interviewed was the guardian of 11 year old Sammy, who went
blind after getting a shot of ProHeart 6.

Fort Dodge denies that these dogs died or got sick from ProHeart 6.

Faith C.

Jun 18th, 2004 - 10:05 AM

Re: Proheart 6

My two healthy dogs received Proheart 6. My vet promoted it, and it did seem to be a wonderful idea. However, within a few days, both dogs began to show very odd behavior problems...namely combativeness toward humans and especially each other. This lasted for several weeks.

We were lucky that seems to be the only side effect for us. But I can't help but wonder what might be hidden from us. As both of these dogs are large, I thank my lucky stars they weren't so badly affected that they hurt someone during their 'cranky' period. Life did eventually return to normal and the bickering has stopped completely. Our new vet is again encouraging it and I absolutely refuse to give it ever again.

Faith

Chris

Jun 18th, 2004 - 9:04 PM

Proheart 6

Hi Faith

A very wise choice indeed. The following is a notice that was issued to Fort Dodge, and who have had loads of complaints against them. They make the vaccine for the West Nile Virus and are also the manufacturers for Proheart 6 and many others. Say no more!

http://www.fda.gov/foi/warning_letters/g4602d.htm

March 31, 2004

HAND DELIVERED

WARNING LETTER

Ref. RAN 2004-06

Mr. E. Thomas Corcoran, President
Fort Dodge Animal Health, a Division of Wyeth, Inc.
9401 Indian Creek Parkway, Suite 1500
Overland Park, KS 66210

Dear Mr. Corcoran:

On December 1-12, 2003 Food and Drug Administration (FDA) Investigators performed an inspection of your veterinary pharmaceutical manufacturing operation known as Fort Dodge Laboratories, Inc., located at 800 5th Street, N.W., Fort Dodge, Iowa 50501. This inspection revealed serious deviations from the current Good Manufacturing Practice (cGMP) regulations, Title 21, Code of Federal Regulations, Parts 210 and 211 (21 CFR 210 and 211). These deviations cause your drug products to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). Section 501(a)(2)(B) of the Act requires that the methods used in, or the facilities or controls used for, the manufacture, processing, packing, and holding of drugs conform with cGMP to assure that such drugs meet the requirements of the Act as to safety, and have the identity and strength, and meet the quality and purity characteristics, which they purport or are represented to possess.

Deviations observed during the establishment inspection include, but are not limited to the following:

1. The Quality Assurance Auditing Staff failed to fully follow established Standard Operating Procedure (SOP) 81-003-14 with regard to the auditing of personnel working in the aseptic core. The audits performed have not identified deficiencies in the systems designed to prevent microbial contamination of drug products purported to be sterile. [21 CFR 211.22(d)]

2. Employees working in the sterile manufacturing area and sterility suite lack appropriate training in aseptic techniques and aseptic conduct. In addition, these employees have failed to follow established SOPS designed to prevent microbiological contamination of drug products purported to be sterile as evidenced by FDA’s numerous inspectional observations. The inspectional observations include an employee entering the Class [redacted] filling suite with exposed skin between the hood and mask. This same employee was observed to be wearing safety glasses when the Gowning Procedures for the Parenteral

Sterile Filling Area SOP 14-011-12 specifically states in bold letters that safety goggles are to be worn. Forceps used to remove fallen vials were brought out of the Class [redacted] room area into the Class [redacted] area and back into the Class [redacted] area. Employees in room [redacted] aseptic filling room exhibited inappropriate aseptic conduct as evidenced by the observation of rapid movement throughout the Class [redacted] filling room. An operator was observed to reach over uncovered vials being loaded onto the turntable while he was removing vials that had fallen over. The plastic curtains that surround the Class [redacted] area, which are intended to protect the product from contamination, were displaced leaving gaps which could affect air flow in the Class e area. An operator in the sterile tilling suite was observed spraying her fingertips with isopropyl alcohol before collecting personnel environmental monitoring samples from her fingertips. The above-referenced observations reveal significant problems in the training of the employees who perform activities in the sterile core. [21 CFR 211.25(a), 21 CFR 211.28(a), and 21 CFR 211.113(b)]

3. The environmental monitoring systems in the small volume parenteral manufacturing and filling areas are deficient in that your firm has not performed a scientific assessment to identify appropriate environmental monitoring sampling sites during the actual manufacturing and sterile filling operations that could pose the most microbiological risk to the products manufactured. Inspectional observations include failure to perform air sampling in the area near the vial turntable to assess the condition of the air during manual loading of vials. Environmental monitoring of personnel was not performed immediately after a significant intervention into the Class [redacted] area. Equipment such as forceps, carts, and tools used during the filling operation a was observed being sprayed directly over the [redacted] located in the Class [redacted] area during the media fill. This occurred after intervention through the plastic curtains that surround the Class [redacted] area and after Rodac sampling of the plastic curtains was performed. Environmental monitoring for viable organisms in the manufacturing area is done in the center of the room at times when there is no activity in the room. [21 CFR 211.113(b)]

4. No evaluation has been performed to show the adequacy and efficacy of the cleaning and disinfection process used in parenteral filling room [redacted] as specified by SOP 14-014-08 [21 CFR 211.42(c)(10)(v)].

5. Investigations of a batch failure or any of its components processed in the aseptic processing area did not extend to other drug products that may have been associated with a specific failure or discrepancy. The heat exchanger used in the Small Volume Parenteral manufacturing rooms [redacted] and [redacted] was found to be contaminating the water for injection (WFI) with bacteria. The failure investigation did not extend to reviewing the possible impact on other previously manufactured drug products. In addition, the heat exchanger continued to be used to manufacture other parenteral products after the equipment was identified as being contaminated. Furthermore, the filter integrity test procedure outlined in SOP 14-177-01 does not specify a limit on the number of times a filter can be flushed or rewetted. [21 CFR 211.192 and 21 CFR 211.42(c)(10)(vi)]

6. All established procedures for production and process control for manufacturing of pharmaceuticals are not followed and documented at the time of performance. For example, during the filling procedures for Factrel®, Lot 431334, the [redacted] air sampler was not placed in the location designated by SOP 14-017-21. In the Package and Product Integrity Examination established in SOP 14-059-10 specifies that each vial will be visually examined to assure the integrity of the filled and sealed products. During the establishment inspection, one of the analysts assigned to perform the visual inspection was observed to look away from the line on several occasions thus allowing other vials to pass the inspection site. [21 CFR 211.100(b)]

It is our assessment that the deviations listed above and discussed with your firm’s senior management are significant and are a reflection of weaknesses in one or more of the systems designed to control the manufacture of veterinary pharmaceuticals purported to be sterile.

The cGMP deviations noted during the December 2003 establishment inspection, where the firm’s employees failed to follow Standard Operating Procedures, do not appear to be isolated events. On November 12, 1999, your firm recalled a lot of Synovex Plus (Trenbolone Acetate and Estradiol Acetate) because it was released for distribution despite failing content uniformity testing. On or about April 30, 2002, Fort Dodge Animal Health sent a letter to FDA’s Center for Veterinary Medicine's (CVM), Division of Compliance requesting the rework of one lot of Synovex H (Testosterone Propionate, Estradiol Benzoate) because the release assay showed that the product potency was approximately 10% below the labeled claims.

It should also be noted that similar rework requests were made for products manufactured at the Fort Dodge Laboratories, Riverside Drive location. On or about April 15, 2002, Fort Dodge Animal Health sent a letter to CVM’s Division of Compliance requesting rework of one lot of Torbutrol Tablets (Butorphanol Tartrate) because the tablets failed average weight testing. The firm had made a similar request during November 1999 to rework a previous lot of Torbutrol Tablets for a similar failure. On or about May 2, 2002, Fort Dodge Animal Health sent a letter to CVM’s Division of Compliance requesting rework of one lot of EtoGesic Tablets (Etodolac) due to tablet chipping and cracking. The firm made a similar request for three other lots of EtoGesic Tablets on or about May 30, 2001.

The commonality regarding the above referenced reworks is that the firm’s requests stated that personnel training and experience were factors in the product quality as well as failure to follow Standard Operating Procedures.

We reviewed your firm's’s response to the FDA-483 observations dated January 14, 2004 and signed by Michael Mlodzik, Associate Director, Pharmaceutical Regulatory Affairs. We acknowledge that your firm has made some changes and provided additional training to your Quality Assurance Auditing Staff as well as to the employees that work in the sterile core in response to FDA’s inspectional observations. Your firm has revised twenty-two SOPS associated with the sterile core operation, personnel aseptic conduct, environmental monitoring, microbial testing for the water for injection (WFI) system, filter integrity testing, packaging, and product integrity visual examination. Several of the aforementioned SOPS are viewed as critical to achieve cGMP compliance for an aseptic pharmaceutical manufacturing facility. The proposed corrections will be verified during the next establishment inspection.

The above identification of violations is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure adherence with each requirement of the Act and its implementing regulations. Deviations from the cGMP regulations were noted on a FDA Form 483 that was issued to and discussed with Dr. Vickie L. Hall, M.S., Ph.D., Vice President of the Iowa Operations and other members of the staff at the Fort Dodge location during a close-out meeting held on the final day of the inspection. A copy of the FDA Form 483 is enclosed for your information.

You should know that these violations might result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to, seizure and/or injunction. Also, other federal agencies are informed about certain Warning Letters issued by FDA so they may consider this information when awarding government contracts.

Please inform this office, in writing, within fifteen (15) working days of receiving this letter of the steps you are taking to correct these deviations. If the corrective actions are going to extend past fifteen days, please include in your response a detailed and specific timeline for the completion of your actions. In addition, please contact the District Office to schedule a meeting regarding your response to this letter. The written response should be delivered at the meeting. At this meeting, it is anticipated that discussion will be held regarding corrective actions taken by your firm, the effectiveness of these actions, and the status of sterile drug products manufactured under the conditions found during the inspection.

You should direct your reply to Ralph J. Gray, Compliance Officer, at the above address.

Sincerely,

/s/

Charles W. Sedgwick

District Director

Kansas City District

Christine Wyndham-Thomas

Jun 18th, 2004 - 9:34 PM

Re: Proheart 6

Permission to Cross Post:

Beware of Proheart 6 (Moxidectin)

For Your Information:

http://www.dvmnewsmagazine.com/dvm/article/articleDetail.jsp?id=76289

http://www.dogsadversereactions.com/

Please, don't be "taken in" by the ads for this drug; do your research before allowing your dog to be prescribed Proheart 6 (Moxidectin)! You may save the life of your dog! Remember, Rimadyl (carprofen) was touted as a "miracle" drug - and then reports of adverse effects and deaths came pouring in to the FDA Center for Veterinary Medicine!

Jean
(Always for George - Always for the Rimadyl Dogs)
http://hometown.aol.com/luswinton/myhomepage/memorial.html

Christine Wyndham-Thomas

Jul 14th, 2004 - 10:48 AM

Re: Proheart 6

http://news4colorado.com/topstories/local_story_190160639.html

Warning against Proheart 6 - been withdrawn

Christine Wyndham-Thomas

Jul 24th, 2004 - 8:05 AM

Re: Proheart 6

http://www.woitv.com/Global/story.asp?S=2064080&nav=1LFWP1We

The danger of Proheart6 has made headline news.

Christine Wyndham-Thomas

Sep 6th, 2004 - 10:49 AM

Re: Proheart 6 RECALLED

From:
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01312.html
FDA Talk Paper
September 3, 2004

Fort Dodge to Comply with FDA's Request to Recall ProHeart 6 Injectable
Heartworm Product from the Market Due to Serious Health Concerns

Fort Dodge Animal Health, of Overland Park, Kansas, at FDA's request,
has agreed to immediately cease production and recall its heartworm
medication ProHeart®6 from the market until the FDA's concerns about
adverse reaction reports associated with the product can be resolved.
FDA is requesting that the firm continue to conduct research to
determine the cause of related adverse reactions and develop a strategy
to help prevent such problems in the future before the product is
marketed again. The FDA will convene an independent scientific advisory
committee to thoroughly evaluate all available data.

ProHeart®6 is an approved injectable sustained-release heartworm
prevention product for dogs. Heartworm disease is a serious and
potentially fatal condition of dogs, cats, and other species of mammals.
The parasite that causes heartworm disease is transmitted through the
bite of a mosquito.

FDA is also advising veterinarians to avoid administering this product
to dogs until further notice. Pet owners should consult their
veterinarians regarding their pet's health care needs.

Since the product was approved in June 2001, Fort Dodge Animal Health
has cooperated with FDA to investigate numerous adverse event reports.
As a result, Fort Dodge has voluntarily changed the label to include
post approval safety information including rare reports of death and a
caution to practitioners that dogs should have a negative test for
heartworm before administration.

Despite these label changes, FDA is still receiving unexplained adverse
event reports, some of them severe. FDA's concern is based on voluntary
self-reporting to FDA by veterinarians and owners whose dogs have
suffered adverse drug experiences (ADEs) to ProHeart®6 (which contains
the drug moxidectin) as well as the mandatory reporting of adverse
events by Fort Dodge Animal Health.

Fort Dodge Animal Health has agreed to recall any product that has
already been distributed to veterinarians.

As of August 4, 2004, FDA's Center for Veterinary Medicine (CVM) had
received 5,552 adverse event reports for ProHeart®6. The actual number
of adverse events is likely even higher because studies show that only a
fraction of actual ADEs are reported.

The Agency has observed an increase in the number of cases associated
with liver and bleeding abnormalities followed in some cases by death.

Troublesmom

Feb 8th, 2005 - 10:32 AM

Re: Proheart 6

This is to update all of you that has ever allowed the Proheart 6 injection to be given to their dog. Seven of us including my personal vet (only vet with courage to speak out against this horrible product) appeared in front of the FDA/Fort Dodge/Wyeth and a 15 panel committe on January 31st, 2005 in the USA to review evidence presented by FDA and FD/Wyeth regarding the USA product, PH6. Us pet guardians were only allowed five minutes to speak. THe final committee vote, was 8-7 AGAINST ALLOWING PROHEART 6 TO RETURN TO THE MARKET.

My own dog died in 10/2002 due to pulmonary thrombolesiums (blood clots due to dying heartworms) created as a result of PH6. DO note that not one in FOUR vets would ever admit that PH6 could have even harmed him and the drug was only out for a year! Note that Trouble had always tested negative for 11 years for heartworms. He HAD HIDDEN HEARTWORMS. I presented his case and two others whereby documentation was sent by vet specialists that PH6 will mass clear adult heartworms (33 days on the evidence we have) and 45 days on the microfilai (same dog and evidence we have). This means that the rapid clerance of these heartworms could lead to IMHA....which is one of the main diagnosis that the FDA had reported to them after dogs had reactions to PH6 in their opinion. The dog we have evidence from ALSO TESTED A FALSE NEGATIVE- TWICE! Just because a vet tells you your dog is negative does not mean your dog does not have hidden heartworms. The tests the vets use are less EFFICIENT if a dog has a LOW FEMALE HW BURDEN. ONLY THE FEMALE HW can be detected and she must be 6/7/ or 8 mos old! So they could be in your dogs tissue and them never detect them. You must become educated if you want to be sure and protect your dog. I also presented a case in California whereby the only INJECTION given was PH6. That dog is partially paralyzed in his hind legs and the neurologist stated that he felt "that the dog had degenerative nerve cell damage due to toxins) This dog began to seizure within 24 hours and still continues to have seizures.

Should you wish to research this product irregardless if off the market or not, please go to this site www.dogsadversereactions.com We know that PH 12 is being tested in universities in the USA with a projected 2006 arrival. For this to happen there must be MAJOR changes in this product. The vets in the USA voted to allow proheart 6 to be given every 6 mos in lieu of a one year shot....WHY? Because they wanted us to come in more often to spend money. So with that information, perhaps it might help you evaluate your relationship with your current vet if he/she recommended PH6....but that will be your decision of course.

Author	Comment
Jean Aug 9, 03 - 10:17 PM	Proheart 6 You may want to consider alternatives to heartworm prevention. I encourage you to PLEASE do your research on ProHeart 6, a drug that some suspect is causing adverse, sometimes fatal effects in SOME dogs of all breeds and ages. I fear many vets are in the dark about what is happening to the dogs and might be choosing to ignore what they hear or see for themselves firsthand. I speak from experience. Two of my three healthy dogs died, in my opinion, after they received this shot, and my third dog remains on medications to hopefully one day restore his immune system to normal. Email: N/A
Christine Wyndham-Thomas Mar 2nd, 2004 - 11:02 AM	Re: Proheart 6 On local CBS News tonight: Joanne Plumber's dog April was injected with ProHeart 6. 3 weeks later April had to be put to sleep. Within a few weeks, Joanne's dog Kuji died due to complete kidney failure (3 months after she got her ProHeart 6 shot). FDA say there have been more than 4,000 reports of dogs getting sick after getting a shot of ProHeart 6. 400 dogs have died. FDA says this is a "cause for concern." FDA has told Proheart 6 manufacturer Fort Dodge to add "there have been rare reports of death" to the label. Dr. Bob Rogers interviewed - he believes ProHeart 6 harms more than it helps. "I have seen vet meds pulled off the market for less deaths than this." Fort Dodge says that millions of U.S. dogs have benefited from ProHeart6. Also interviewed was the guardian of 11 year old Sammy, who went blind after getting a shot of ProHeart 6. Fort Dodge denies that these dogs died or got sick from ProHeart 6. Email: christine@dogsonholiday-uk.com
Faith C. Jun 18th, 2004 - 10:05 AM	Re: Proheart 6 My two healthy dogs received Proheart 6. My vet promoted it, and it did seem to be a wonderful idea. However, within a few days, both dogs began to show very odd behavior problems...namely combativeness toward humans and especially each other. This lasted for several weeks. We were lucky that seems to be the only side effect for us. But I can't help but wonder what might be hidden from us. As both of these dogs are large, I thank my lucky stars they weren't so badly affected that they hurt someone during their 'cranky' period. Life did eventually return to normal and the bickering has stopped completely. Our new vet is again encouraging it and I absolutely refuse to give it ever again. Faith Email: wyldangel1@excite.com ICQ: 161236
Chris Jun 18th, 2004 - 9:04 PM	Proheart 6 Hi Faith A very wise choice indeed. The following is a notice that was issued to Fort Dodge, and who have had loads of complaints against them. They make the vaccine for the West Nile Virus and are also the manufacturers for Proheart 6 and many others. Say no more! http://www.fda.gov/foi/warning_letters/g4602d.htm March 31, 2004 HAND DELIVERED WARNING LETTER Ref. RAN 2004-06 Mr. E. Thomas Corcoran, President Fort Dodge Animal Health, a Division of Wyeth, Inc. 9401 Indian Creek Parkway, Suite 1500 Overland Park, KS 66210 Dear Mr. Corcoran: On December 1-12, 2003 Food and Drug Administration (FDA) Investigators performed an inspection of your veterinary pharmaceutical manufacturing operation known as Fort Dodge Laboratories, Inc., located at 800 5th Street, N.W., Fort Dodge, Iowa 50501. This inspection revealed serious deviations from the current Good Manufacturing Practice (cGMP) regulations, Title 21, Code of Federal Regulations, Parts 210 and 211 (21 CFR 210 and 211). These deviations cause your drug products to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). Section 501(a)(2)(B) of the Act requires that the methods used in, or the facilities or controls used for, the manufacture, processing, packing, and holding of drugs conform with cGMP to assure that such drugs meet the requirements of the Act as to safety, and have the identity and strength, and meet the quality and purity characteristics, which they purport or are represented to possess. Deviations observed during the establishment inspection include, but are not limited to the following: 1. The Quality Assurance Auditing Staff failed to fully follow established Standard Operating Procedure (SOP) 81-003-14 with regard to the auditing of personnel working in the aseptic core. The audits performed have not identified deficiencies in the systems designed to prevent microbial contamination of drug products purported to be sterile. [21 CFR 211.22(d)] 2. Employees working in the sterile manufacturing area and sterility suite lack appropriate training in aseptic techniques and aseptic conduct. In addition, these employees have failed to follow established SOPS designed to prevent microbiological contamination of drug products purported to be sterile as evidenced by FDA’s numerous inspectional observations. The inspectional observations include an employee entering the Class [redacted] filling suite with exposed skin between the hood and mask. This same employee was observed to be wearing safety glasses when the Gowning Procedures for the Parenteral Sterile Filling Area SOP 14-011-12 specifically states in bold letters that safety goggles are to be worn. Forceps used to remove fallen vials were brought out of the Class [redacted] room area into the Class [redacted] area and back into the Class [redacted] area. Employees in room [redacted] aseptic filling room exhibited inappropriate aseptic conduct as evidenced by the observation of rapid movement throughout the Class [redacted] filling room. An operator was observed to reach over uncovered vials being loaded onto the turntable while he was removing vials that had fallen over. The plastic curtains that surround the Class [redacted] area, which are intended to protect the product from contamination, were displaced leaving gaps which could affect air flow in the Class e area. An operator in the sterile tilling suite was observed spraying her fingertips with isopropyl alcohol before collecting personnel environmental monitoring samples from her fingertips. The above-referenced observations reveal significant problems in the training of the employees who perform activities in the sterile core. [21 CFR 211.25(a), 21 CFR 211.28(a), and 21 CFR 211.113(b)] 3. The environmental monitoring systems in the small volume parenteral manufacturing and filling areas are deficient in that your firm has not performed a scientific assessment to identify appropriate environmental monitoring sampling sites during the actual manufacturing and sterile filling operations that could pose the most microbiological risk to the products manufactured. Inspectional observations include failure to perform air sampling in the area near the vial turntable to assess the condition of the air during manual loading of vials. Environmental monitoring of personnel was not performed immediately after a significant intervention into the Class [redacted] area. Equipment such as forceps, carts, and tools used during the filling operation a was observed being sprayed directly over the [redacted] located in the Class [redacted] area during the media fill. This occurred after intervention through the plastic curtains that surround the Class [redacted] area and after Rodac sampling of the plastic curtains was performed. Environmental monitoring for viable organisms in the manufacturing area is done in the center of the room at times when there is no activity in the room. [21 CFR 211.113(b)] 4. No evaluation has been performed to show the adequacy and efficacy of the cleaning and disinfection process used in parenteral filling room [redacted] as specified by SOP 14-014-08 [21 CFR 211.42(c)(10)(v)]. 5. Investigations of a batch failure or any of its components processed in the aseptic processing area did not extend to other drug products that may have been associated with a specific failure or discrepancy. The heat exchanger used in the Small Volume Parenteral manufacturing rooms [redacted] and [redacted] was found to be contaminating the water for injection (WFI) with bacteria. The failure investigation did not extend to reviewing the possible impact on other previously manufactured drug products. In addition, the heat exchanger continued to be used to manufacture other parenteral products after the equipment was identified as being contaminated. Furthermore, the filter integrity test procedure outlined in SOP 14-177-01 does not specify a limit on the number of times a filter can be flushed or rewetted. [21 CFR 211.192 and 21 CFR 211.42(c)(10)(vi)] 6. All established procedures for production and process control for manufacturing of pharmaceuticals are not followed and documented at the time of performance. For example, during the filling procedures for Factrel®, Lot 431334, the [redacted] air sampler was not placed in the location designated by SOP 14-017-21. In the Package and Product Integrity Examination established in SOP 14-059-10 specifies that each vial will be visually examined to assure the integrity of the filled and sealed products. During the establishment inspection, one of the analysts assigned to perform the visual inspection was observed to look away from the line on several occasions thus allowing other vials to pass the inspection site. [21 CFR 211.100(b)] It is our assessment that the deviations listed above and discussed with your firm’s senior management are significant and are a reflection of weaknesses in one or more of the systems designed to control the manufacture of veterinary pharmaceuticals purported to be sterile. The cGMP deviations noted during the December 2003 establishment inspection, where the firm’s employees failed to follow Standard Operating Procedures, do not appear to be isolated events. On November 12, 1999, your firm recalled a lot of Synovex Plus (Trenbolone Acetate and Estradiol Acetate) because it was released for distribution despite failing content uniformity testing. On or about April 30, 2002, Fort Dodge Animal Health sent a letter to FDA’s Center for Veterinary Medicine's (CVM), Division of Compliance requesting the rework of one lot of Synovex H (Testosterone Propionate, Estradiol Benzoate) because the release assay showed that the product potency was approximately 10% below the labeled claims. It should also be noted that similar rework requests were made for products manufactured at the Fort Dodge Laboratories, Riverside Drive location. On or about April 15, 2002, Fort Dodge Animal Health sent a letter to CVM’s Division of Compliance requesting rework of one lot of Torbutrol Tablets (Butorphanol Tartrate) because the tablets failed average weight testing. The firm had made a similar request during November 1999 to rework a previous lot of Torbutrol Tablets for a similar failure. On or about May 2, 2002, Fort Dodge Animal Health sent a letter to CVM’s Division of Compliance requesting rework of one lot of EtoGesic Tablets (Etodolac) due to tablet chipping and cracking. The firm made a similar request for three other lots of EtoGesic Tablets on or about May 30, 2001. The commonality regarding the above referenced reworks is that the firm’s requests stated that personnel training and experience were factors in the product quality as well as failure to follow Standard Operating Procedures. We reviewed your firm's’s response to the FDA-483 observations dated January 14, 2004 and signed by Michael Mlodzik, Associate Director, Pharmaceutical Regulatory Affairs. We acknowledge that your firm has made some changes and provided additional training to your Quality Assurance Auditing Staff as well as to the employees that work in the sterile core in response to FDA’s inspectional observations. Your firm has revised twenty-two SOPS associated with the sterile core operation, personnel aseptic conduct, environmental monitoring, microbial testing for the water for injection (WFI) system, filter integrity testing, packaging, and product integrity visual examination. Several of the aforementioned SOPS are viewed as critical to achieve cGMP compliance for an aseptic pharmaceutical manufacturing facility. The proposed corrections will be verified during the next establishment inspection. The above identification of violations is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure adherence with each requirement of the Act and its implementing regulations. Deviations from the cGMP regulations were noted on a FDA Form 483 that was issued to and discussed with Dr. Vickie L. Hall, M.S., Ph.D., Vice President of the Iowa Operations and other members of the staff at the Fort Dodge location during a close-out meeting held on the final day of the inspection. A copy of the FDA Form 483 is enclosed for your information. You should know that these violations might result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to, seizure and/or injunction. Also, other federal agencies are informed about certain Warning Letters issued by FDA so they may consider this information when awarding government contracts. Please inform this office, in writing, within fifteen (15) working days of receiving this letter of the steps you are taking to correct these deviations. If the corrective actions are going to extend past fifteen days, please include in your response a detailed and specific timeline for the completion of your actions. In addition, please contact the District Office to schedule a meeting regarding your response to this letter. The written response should be delivered at the meeting. At this meeting, it is anticipated that discussion will be held regarding corrective actions taken by your firm, the effectiveness of these actions, and the status of sterile drug products manufactured under the conditions found during the inspection. You should direct your reply to Ralph J. Gray, Compliance Officer, at the above address. Sincerely, /s/ Charles W. Sedgwick District Director Kansas City District Email: christine@dogsonholiday-uk.com
Christine Wyndham-Thomas Jun 18th, 2004 - 9:34 PM	Re: Proheart 6 Permission to Cross Post: Beware of Proheart 6 (Moxidectin) For Your Information: http://www.dvmnewsmagazine.com/dvm/article/articleDetail.jsp?id=76289 http://www.dogsadversereactions.com/ Please, don't be "taken in" by the ads for this drug; do your research before allowing your dog to be prescribed Proheart 6 (Moxidectin)! You may save the life of your dog! Remember, Rimadyl (carprofen) was touted as a "miracle" drug - and then reports of adverse effects and deaths came pouring in to the FDA Center for Veterinary Medicine! Jean (Always for George - Always for the Rimadyl Dogs) http://hometown.aol.com/luswinton/myhomepage/memorial.html Email: christine@dogsonholiday-uk.com
Christine Wyndham-Thomas Jul 14th, 2004 - 10:48 AM	Re: Proheart 6 http://news4colorado.com/topstories/local_story_190160639.html Warning against Proheart 6 - been withdrawn Email: christine@dogsonholiday-uk.com
Christine Wyndham-Thomas Jul 24th, 2004 - 8:05 AM	Re: Proheart 6 http://www.woitv.com/Global/story.asp?S=2064080&nav=1LFWP1We The danger of Proheart6 has made headline news. Email: christine@dogsonholiday-uk.com
Christine Wyndham-Thomas Sep 6th, 2004 - 10:49 AM	Re: Proheart 6 RECALLED From: http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01312.html FDA Talk Paper September 3, 2004 Fort Dodge to Comply with FDA's Request to Recall ProHeart 6 Injectable Heartworm Product from the Market Due to Serious Health Concerns Fort Dodge Animal Health, of Overland Park, Kansas, at FDA's request, has agreed to immediately cease production and recall its heartworm medication ProHeart®6 from the market until the FDA's concerns about adverse reaction reports associated with the product can be resolved. FDA is requesting that the firm continue to conduct research to determine the cause of related adverse reactions and develop a strategy to help prevent such problems in the future before the product is marketed again. The FDA will convene an independent scientific advisory committee to thoroughly evaluate all available data. ProHeart®6 is an approved injectable sustained-release heartworm prevention product for dogs. Heartworm disease is a serious and potentially fatal condition of dogs, cats, and other species of mammals. The parasite that causes heartworm disease is transmitted through the bite of a mosquito. FDA is also advising veterinarians to avoid administering this product to dogs until further notice. Pet owners should consult their veterinarians regarding their pet's health care needs. Since the product was approved in June 2001, Fort Dodge Animal Health has cooperated with FDA to investigate numerous adverse event reports. As a result, Fort Dodge has voluntarily changed the label to include post approval safety information including rare reports of death and a caution to practitioners that dogs should have a negative test for heartworm before administration. Despite these label changes, FDA is still receiving unexplained adverse event reports, some of them severe. FDA's concern is based on voluntary self-reporting to FDA by veterinarians and owners whose dogs have suffered adverse drug experiences (ADEs) to ProHeart®6 (which contains the drug moxidectin) as well as the mandatory reporting of adverse events by Fort Dodge Animal Health. Fort Dodge Animal Health has agreed to recall any product that has already been distributed to veterinarians. As of August 4, 2004, FDA's Center for Veterinary Medicine (CVM) had received 5,552 adverse event reports for ProHeart®6. The actual number of adverse events is likely even higher because studies show that only a fraction of actual ADEs are reported. The Agency has observed an increase in the number of cases associated with liver and bleeding abnormalities followed in some cases by death. Email: christine@dogsonholiday-uk.com
Troublesmom Feb 8th, 2005 - 10:32 AM	Re: Proheart 6 This is to update all of you that has ever allowed the Proheart 6 injection to be given to their dog. Seven of us including my personal vet (only vet with courage to speak out against this horrible product) appeared in front of the FDA/Fort Dodge/Wyeth and a 15 panel committe on January 31st, 2005 in the USA to review evidence presented by FDA and FD/Wyeth regarding the USA product, PH6. Us pet guardians were only allowed five minutes to speak. THe final committee vote, was 8-7 AGAINST ALLOWING PROHEART 6 TO RETURN TO THE MARKET. My own dog died in 10/2002 due to pulmonary thrombolesiums (blood clots due to dying heartworms) created as a result of PH6. DO note that not one in FOUR vets would ever admit that PH6 could have even harmed him and the drug was only out for a year! Note that Trouble had always tested negative for 11 years for heartworms. He HAD HIDDEN HEARTWORMS. I presented his case and two others whereby documentation was sent by vet specialists that PH6 will mass clear adult heartworms (33 days on the evidence we have) and 45 days on the microfilai (same dog and evidence we have). This means that the rapid clerance of these heartworms could lead to IMHA....which is one of the main diagnosis that the FDA had reported to them after dogs had reactions to PH6 in their opinion. The dog we have evidence from ALSO TESTED A FALSE NEGATIVE- TWICE! Just because a vet tells you your dog is negative does not mean your dog does not have hidden heartworms. The tests the vets use are less EFFICIENT if a dog has a LOW FEMALE HW BURDEN. ONLY THE FEMALE HW can be detected and she must be 6/7/ or 8 mos old! So they could be in your dogs tissue and them never detect them. You must become educated if you want to be sure and protect your dog. I also presented a case in California whereby the only INJECTION given was PH6. That dog is partially paralyzed in his hind legs and the neurologist stated that he felt "that the dog had degenerative nerve cell damage due to toxins) This dog began to seizure within 24 hours and still continues to have seizures. Should you wish to research this product irregardless if off the market or not, please go to this site www.dogsadversereactions.com We know that PH 12 is being tested in universities in the USA with a projected 2006 arrival. For this to happen there must be MAJOR changes in this product. The vets in the USA voted to allow proheart 6 to be given every 6 mos in lieu of a one year shot....WHY? Because they wanted us to come in more often to spend money. So with that information, perhaps it might help you evaluate your relationship with your current vet if he/she recommended PH6....but that will be your decision of course. Email: protectyourdog@aol.com

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