thanks for your post! Actually, i've been researching for myself and found the exact same thing about Capstar since last week. In fact, the title of this thread is a bit misleading now, since i also found out that it's not even Bob Martin's company who make this product, it's Novartis UK (who also make Capstar... it's probably EXACTLY the same product). It's just sold in Bob Martin packaging.
So far, i haven't contacted any media organisations. I wanted to talk first to those who are directly concerned. So, Bob Martin's company, and the Vetinary Medicines Directorate. That seems to me to have the highest chance of getting something changed. I will contact them if nothing gets done another way though.
Bob Martin's company were very good at replying to my original email, but seem to have ignored my emails requesting them to change the product labelling. However, i also found the legislation about product labelling in the UK, and contraindications and warnings should also definately be on the packaging here. It may be that the leaflet instruction also comes from Novartis though, and we were just unlucky in buying an old box.
I sent back one of the tablets to them for analysis, so when they get back to me with the results, i will ask them this directly.
In the meantime, I also contacted the legislation department of the VMD to see about getting supermarket leaflets changed. One of the things i asked was just what you said, Codex... that it would be really helpful to say on the box (of all potentially harmful products) that you should only administer them at a time when you can watch for adverse effects for the next 12 hours.
Here's the email, if anyone's interested. I haven't had any response yet from them either though.
"Dear Alison Barry,
I found your email address from the contact list available from the website, but i'm not sure if you're the right person to contact about this. If not, please could you forward this message to the right person?
I recently reported a serious adverse reaction on the VMD website. We gave one of "Bob Martin flea tablets for cats and small dogs" (containing 11.4mg of Nitenpyram) to my cat in the evening on Monday. He suffered a very severe adverse reaction to this, and when we came down the following morning, he was paralysed and having seizures (twitching), and had vomited and pood himself in the night. He had to be put down.
I understand that such adverse reactions are rare events, and i'm very glad that an independant body is monitoring them! However, there are some things I am very concerned about with the product labelling, and would like to ask you to make the legislation to change it, if possible.
Firstly, nowhere on the box or leaflet on this product was any information whatsoever that such a serious adverse reaction could occur. There were no contraindications listed, and no symptoms listed to make you aware if the product was causing such a reaction. I am happy to send you a copy of the packaging and leaflet if this would help.
Obviously, this is against your current legislation. However, when I researched the product on your database, I found that this product is actually made by Novartis (UK) Ltd, and only sold in Bob Martin packaging. When I researched the same flea tablets under Novartis, I found this letter, relating to Capstar (which seems to be the same product with a different name):
http://www.capstarpet.com/pdf/Dear_Doctor.pdf
So, it seems like the leaflet may have changed already, and we were just unlucky to buy a box within the 8 month time period it takes to make sure all boxes have that leaflet in them (although they missed paralysis and death from the end of the list even in the newer labelling).
Anyway, to get to the point of this email, here are the things I would very much like to see changed in the legislation, if possible. I've thought about these ideas from my own perspective, as a cat owner who has seen their cat experience such an adverse reaction. If possible, i'd like to help stop other pets dieing in the way that mine did, and other pet owners from experiencing the guilt and horror that they've given their pet something that ultimately killed them. So, the following ideas are written from the starting point that if they had been in legislation at the time, my cat might not have suffered and died the way he did. The ideas are primarily intended for implementation on over the counter, supermarket products (which probably have less robust testing and labelling than prescription products).
1. All products which could potentially cause an adverse reaction, but which may be too new to have enough adverse reactions reported to substantiate detailed information on the package labelling should come with a clear instruction that the pet owner should only administer the drug at a time when they can watch their pet for any adverse symptoms for the following 12 hours.
- if this had been on the packaging, we would have given the tablet to our cat in the morning rather than in the evening, and we would have known much sooner that something was very wrong (rather than being in bed asleep), and been able to take him to the vet much more quickly.
2. All such newer products should also come with a warning as standard about which groups of animals were at highest risk of experiencing serious adverse reactions to similar products, and to always consult the vet before using the product if your pet falls into one of these groups (e.g. very young or old animals, pregnant animals, animals experiencing other health problems).
- my cat was over 15, and was on anti-biotics for a urine infection. If this had been on the product, we wouldn't have given it at all. The product didn't mention any of this, and instead said "use instead of flea spray or shampoo", so we assumed it was very safe.
3. Once adverse reaction reporting has become robust enough to substantiate detailed information of possible symptoms on the packaging, some attempt should be made to distinguish between potentially serious and non serious side effects on the labelling.
Since almost all human medications have some side effects, I assume the same is true of vetinary products. On human medication packaging, there is both a list of symptoms in order of most to least common, and a warning with a subset of side effects to consult your doctor immediately if you experience any of those. This helps people distinguish between transient and less potentially damaging side effects, and those symptoms which indicate that the reaction may be severe, and requires immediate medical attention. The same should hold for vetinary products, especially since pet owners often don't have even the minimal medical knowledge they have for humans.
- one of the side effects my cat experienced was shaking / trembling within 5 minutes of having given the tablet to him. I was worried at the time that this indicated that something in my cat's nervous system was being affected (rather than just the fleas'), but the effect was transitory, and stopped soon after. I don't know if this was actually an indication that I should have taken him to the vet straight away, for example. I don't know the difference between minor and potentially more serious side effects in cats. I'm sure a lot of other pet owners are in the same situation.
4. All products sold in the UK should come with information about what the VMD is, what it's role is with regards to selling animal related products, and the web address for adverse effect reporting.
- before this happened, i didn't even know the VMD existed, that supermarket products could have such serious adverse effects, or that you should report them to the VMD. So I think that it's probable that many other people also aren't aware of this too. It seems pointless to have a VM number on products if people aren't even generally aware of what that stands for. I'm sure the efficacy of adverse effect reporting would also grow much higher if this information was included as standard on all products.
Thankyou for taking the time to read this long email... I hope you will seriously consider these ideas and the benefits of using them on labelling.
Hope to hear back from you on this"