Adverse Reactions to Medication

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zeta1454
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Adverse Reactions to Medication

Post by zeta1454 » 05 Apr 2018, 15:42

Every year the European Medicines Agency publishes a document detailing veterinary products that have been officially reported to have caused adverse reactions or death. Although the vast majority of people never officially file a report to the Veterinary Medicines Directorate or similar body if their dog suffers a side effect to a medicine, anti-parasite product or vaccine and therefore the numbers quoted may be a fraction of the actual figures, the report is useful to give an indication of those products which do have a significant number of reports and those which are receiving special monitoring as a result.

Some products which have been highlighted by Forum members as causing issues in their dogs over the past years are mentioned in this latest report (The initials used for MAH is Marketing Authorisation Holder and PSUR is Periodic Safety Update Reports):

Advocate: Due to the relatively high number of reports regarding convulsions, the MAH has been requested to monitor this signal for the next PSUR and consider updating the product information, if necessary.

Apoquel: Potential signals involving signs associated with respiratory tract disorders were identified during routine surveillance in 2017 and will continue to be monitored.
Additionally, the MAH has been requested to continue monitoring reports involving unexpected signs associated with blood and lymphatic system disorders, in particular reports involving the signs lymphoma or lymphosarcoma and comment specifically on such reports in the next PSUR.

A potential signal relating to immunosuppression in humans following repeated handling of the product was noted during routine surveillance in 2017. Future reports of adverse events in humans following dermal exposure will continue to be monitored to ensure that warnings in the product information remain adequate.


Bravecto: The MAH provided a targeted PSUR that included an extensive analysis and review of all serious reaction reports with neurological disorders, skin and appendages disorders, hypersensitivity/immune mediated reactions and hepatopathy, including cases that led to death and/or death by euthanasia.

After analysis of those data, the following changes to the product information were recommended (additions to text in bold):
Section 4.5 Special precautions for use in animals

Use with caution in dogs with pre-existing epilepsy.

Section 4.6 Adverse reactions (frequency and seriousness)

Convulsions and lethargy have been reported very rarely in spontaneous (pharmacovigilance) reports.

Canigen/Nobivac Lepto4:

The MAH has been requested to provide a targeted PSUR on adverse events concerning death and/or death by euthanasia covering the period since authorisation until 31 December 2017.

Canigen L4, Nobivac L4 & Versican
Plus DHPPi/L4, Plus DHPPi/L4R, Plus L4, Plus Pi/L4, Plus Pi L4R (for active immunisation of dogs against Leptospira):


A high number of reports of painful local reactions and systemic reactions were reported with different multivalent Leptospira vaccines. Further investigations on the underlying cause e.g. potential role of the additional antigenic load, are under investigation.

The report notes that:
"A total of 26,598 adverse event reports relating to exposure to centrally authorised products were received in 2017. Of these, 25,890 adverse event reports related to animals and 708 adverse event reports related to humans exposed to a veterinary medicinal product."
90% of these related to dogs and cats and the most significant products causing adverse reactions / death were anti-parasitics (flea, tick and worm treatments) at 40% and vaccines at 23%.

For those who would like to read the full report, this is the link:
http://www.ema.europa.eu/docs/en_GB/doc ... 246339.pdf" onclick="window.open(this.href);return false;" onclick="window.open(this.href);return false;

Although some of these and other veterinary products have been confirmed to have caused death or severe temporary or permanent damage to dogs, figures in hundreds or even a few thousand are not regarded as statistically significant enough to have the product withdrawn. This is why it is important to officially report every serious reaction in order to make the reality of the dangers attached to certain products more meaningful and less able to be ignored. While some side effects from vital life saving medication may be considered acceptable, death and disability resulting from a regular use of a flea / worming treatment or an unnecessary vaccine is not IMO.
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Bracken 01
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Re: Adverse Reactions to Medication

Post by Bracken 01 » 09 Apr 2018, 20:46

Thank you for the info. This forum is so informative.Thank you all who are involved in running this Schnauzer forum.Back too the subject.I try as much as I can with Bracken to go non chemical. The last two years Bracken has suffered with Harvest mites,the first year his feet where infected, I put thornit powder in a plastic bag and put his paws in the bag and massaged, done the trick :) .
Last year the mites infected his ears the thornit didn't work :( , I really took my eye off the ball as I should really treat his ears regularly with thornit, maybe if I had, could have been a different story.
I phoned the Breeder, she told me too use Advocate, she doesn't like using it, but uses it once a year on her dogs.
Any ideas if I have the same problem, what else if anything can I use.

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Re: Adverse Reactions to Medication

Post by zeta1454 » 10 Apr 2018, 09:45

Bracken 01 wrote:Thank you for the info. This forum is so informative.Thank you all who are involved in running this Schnauzer forum.Back too the subject.I try as much as I can with Bracken to go non chemical. The last two years Bracken has suffered with Harvest mites,the first year his feet where infected, I put thornit powder in a plastic bag and put his paws in the bag and massaged, done the trick :) .
Last year the mites infected his ears the thornit didn't work :( , I really took my eye off the ball as I should really treat his ears regularly with thornit, maybe if I had, could have been a different story.
I phoned the Breeder, she told me too use Advocate, she doesn't like using it, but uses it once a year on her dogs.
Any ideas if I have the same problem, what else if anything can I use.
Hi Annie - glad to know that the Forum is helpful :)

Thornit powder is a good product for keeping a dog's ears clear of mites / infection but does need to be used regularly and, as with many natural products, may take a while to establish and so not always ideal for sudden emergencies with ear mites. Most powders will kill off parasites like mites and fleas by fatally damaging their body structure but without adversely affecting the dog. Diatomaceous Earth (human grade powder) is also a good preventative or treatment for a dog with these kind of parasites and if taken internally (a teaspooon mixed into food) will also clear worms and some toxins from the gut.

With ears, apart from Thornit, a product we have found useful is Stinky Stuff which despite the off-putting name is excellent for clearing ear issues:
https://www.stinky-stuff.co.uk/products ... ear-drops/" onclick="window.open(this.href);return false;" onclick="window.open(this.href);return false;

There is also a useful website My Itchy Dog which stocks a range of plant based / herbal medications and treatments for dogs:
https://www.myitchydog.co.uk/skin-coat-treatments.html" onclick="window.open(this.href);return false;" onclick="window.open(this.href);return false;

There may be serious conditions which could justify the use of the pesticide type treatments such as Advocate but it is important to be aware of the nature of the chemicals in this type of product and the extensive warnings and precautions relating to it which can be read under Contraindications and Warnings on this official data sheet:
http://www.noahcompendium.co.uk/?id=-44 ... _printview" onclick="window.open(this.href);return false;" onclick="window.open(this.href);return false;

If it is used in emergency, it will not remain effective for much longer than a month from application as far as I know which is why it is promoted as a regular treatment.

Although I can say that our dogs have been free of parasites for many years without using chemical wormers or flea/tick/ mite treatments, I cannot say for certain whether it is also due to the fact that they are raw fed, fit and healthy, and not vaccinated after puppy jabs, all of which I believe strengthens their natural immune system. We live in the country and the dogs enjoy outdoor activities in woods, by the canal and in fields as well as in our large garden. We do have rats in the garden (occasionally?) from the arable farm fields that back on to our garden so the dogs are not isolated from contact with potential parasites etc. They do have Dorwest Keepers Mix added to their raw meat daily and a Garlic & Fenugreek tablet from Dorwest too. Garlic and other herbs can change the scent of the dog's blood which acts as a natural repellent to many biting insects. The Billy No Mates range also works on this principle and we have in the past used their herbal mix in the summer months although it does need to be started about six weeks before the warmer weather when ticks and fleas are most prevalent. These supplements and tablets are beneficial in other respects to our dogs so I am happy to use them and, if they are helping keep the dogs free of parasite infestation as well that is a worthwhile bonus :)

I would definitely check out the links above to see if any of the products might be helpful to you and do try the Stinky Stuff for ears with Bracken. Do let us know how you get on through the year as it is always great to hear Forum members' experiences with any product for their dogs and there are many things I have not used with our dogs so could not comment on from personal experience.
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Bracken 01
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Re: Adverse Reactions to Medication

Post by Bracken 01 » 17 Apr 2018, 18:40

Thanks Zeta will try Stinky stuff, I use Billy no mates and Bracken is fed raw.Like your dogs has only had his puppy jabs.Brackens coat is really thick and when grown is curly too, ideal for mites, but he has never had fleas.
I also will look at the Dorwest Garlic Tablets, he can at times be fussy with his food, not sure about putting anything on dinner.

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Re: Adverse Reactions to Medication

Post by zeta1454 » 15 Jun 2019, 17:51

I have just seen a post on the Northern Schnauzer Club Facebook page regarding a miniature schnauzer puppy that has died after being given the Lepto4 vaccine. This is a very tragic case especially as the puppy's family had told the vet they were concerned about this vaccine but were persuaded to have it given as the surgery did not stock Lepto2 and the vet assured them the Lepto4 was safe :(
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Re: Adverse Reactions to Medication

Post by Oscar 12345 » 15 Jun 2019, 18:08

That's awful, devastating doesn't do it justice does it. I persuaded my friend not to have the L4, the breeder gave L2 for first injection but her vet only stocked L4 so wanted to give the whole thing again citing that it would all be absolutely fine. Appalling really. She found another vet. There surely must be enough evidence now to do something about this vaccine.
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Re: Adverse Reactions to Medication

Post by Dawnspell » 15 Jun 2019, 21:46

Our breeder asked me in advance to find out what vaccines our vet used. She won't let her puppies have the lepto4.
So sad
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Re: Adverse Reactions to Medication

Post by zeta1454 » 16 Jun 2019, 05:49

It is disturbing to me that while more and more reports are coming in about certain medications and products such as Bravecto and Lepto4, they are still just being "monitored" and some vets are continuing to promote them while animals are suffering serious health consequences or death. This link it is to the most recent (2018) European Medicines Agency Veterinary Pharmacovigilance Report which highlights ( in the table on Page 4 of the report) the products where there is particular concern and why:

https://www.ema.europa.eu/en/documents/ ... 018_en.pdf

There is also a table on Page 11 showing adverse effects on humans who have handled some of these products where Bravecto (spot on) again has some worrying effects.
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Re: Adverse Reactions to Medication

Post by Oscar 12345 » 16 Jun 2019, 14:39

That document is really helpful Leigh. Thanks.
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Re: Adverse Reactions to Medication

Post by Schnauzer Sam » 16 Jun 2019, 17:32

Thanks for posting this Leigh. What I find most disturbing is that most (if not all) of the front line flea treatments being issued by every vet is listed. Advocate/Bravecto/Credilio/Nexgard/Symparica are all on the list and the only other ones I know are Frontline and Advantage and they seem to have lost their efficacy.

Then others on this "watch list" are basic drugs such as pain relief or treatment for ear rashes or to relieve itchiness.

This really is shocking and it's difficult to understand why this is continuing other than the drug companies have deep pockets for their lobbyists.

Regarding the lepto 4, I had to persuade my breeder not to give Edie the Lepto 4 jab. She told me her vet wasn't impressed. My own vet here in Guernsey tried to convince me to have it done and explained that in a pup, the condition would be fatal but if she was older and we were vigilant then it is treatable and so we agreed that they would give the Lepto 2.

Edie was 1 this week and I have refused the "annual" vaccinations. I spoke to the vet about the WSAVA guidelenes and said that the manufacturers say their vaccinations are valid for a minimum of 3 years and I just refused to entertain the consideration of any lepto. We agreed that at 3 years old they would perform a titre test. I asked for a note to be put on Edie's file confirming that they agreed that my wishes were reasonable.

I mentioned before on another thread that I have confirmed with my insurers (Petplan) that a titre test meets their requirement for being covered and even if following a vaccination plan then every 3 years will suffice "as long as that program of action has been recommended by your vet". In other words - if your vet recommends annual boosters and you turn them down then make sure you get the vet to accept that you are following the advice of the WSAVA or you may have difficulties with a future claim.
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Re: Adverse Reactions to Medication

Post by zeta1454 » 27 Oct 2019, 17:26

Just adding an update from the FDA in the US regarding a range of flea / tick products which are of concern due to the number of reports of neurological damage to pets following their use. A number of these are already highlighted in my original post above but this has been produced specifically to inform pet owners and vets of the potential dangers of these products:

https://www.fda.gov/animal-veterinary/c ... neurologic

And the fact sheet for pet owners:

https://www.fda.gov/animal-veterinary/a ... oline-flea
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