What does it mean when a drug isn't licenced for a treatment?(17 Posts)
Doctor 1 is suggesting drug X for treating condition A.
Doctor 2 suggests a different way of treating condition A and points out that whilst safe, drug X isn't licenced to treat condition A ( but is fine for condition Z - which is unrelated and that I don't have).
What does this mean about Doctor 1's plan? Is it experimental / a new approach / something else? Should Doctor 1 have told me about this (I only got a 2nd opinion because I didn't like the sound of the treatment not because I felt it was unsuitable). It's the only option Doctor 1 put on the table (although acknowledged there were other treatments that could be available privately but that Doctor 1 couldn't couldn't advise on).
So licensing a drug is expensive, companies will go for the most lucrative condition to achieve licence.
Sometimes whilst in trials they find out it also works for different conditions but by chance.
Because they didn't apply for the licence to treat that condition they write reports/literature about the second benefits but may never apply for the licence.
It can be used for wheatever it works for under the guise of a professional.
It doesn't mean it's unsafe or untested, hope it does help
My DS has been given an unlicensed drug. It was Piriton (or another antihistamine).
It was considered unlicensed as the box recommends for over ones and he was 9 months. He's also been prescribed unlicensed eye drops.
A lot of the time it's down to a recommended age or it being licensed to treat one condition but the doctor prescribes it to treat another condition which he knows it will work for but hasn't been clinically tested for.
This is how it was explained to me when I called a pharmacy freaking out about prescriptions!
As weak said , we use lots of drugs out of " their initial tended use" for example we use some antidepressants at a lower dose as pain relief, some antihistamines as a sleeping aid and some diabetic medications to treat blood pressure .
It happens all the time and doesn't mean they are not safe or that they won't work as they would only be prescribed if we know that they do work for the chosen condition we are hoping to treat.
What weak said. It doesn't mean the doctors approach is experimental. It's often termed off label prescribing, and fairly common.
Pharmaceutical companies have to have a licence to sell drugs. In the UK licences are regulated by the MHRA & EUDRA - pharmaceutical companies have to apply to the MHRA for a licence and comply with the regulations set by the MHRA (& EUDRA), which include providing information on what the drug is licensed to treat & medical evidence that the drug is effective and safe. If the drug you are posting about is not licensed in the UK to treat your condition it most likely means when the licence was applied for in the UK this information was not included in relation to your medical condition. However this drug may be licensed to treat your condition in other areas (likely if your GP is recommending it for you) - drug companies are amending their licences all the time and if they sell a drug globally they will need to amend multiple licences with each of the relevant regulatory authorities, which is expensive and can take a long time. It may be that the UK licence will be amended in due course.
It could also be that a pharmaceutical company has not applied for a UK licence at all - maybe because they or other drug companies have licences for very similar drugs in the UK, there are very cheap generic versions of similar drugs already licensed, or even because they are currently able to sell the drug off licence (lack of alternative products & patient need for example).
In short, just because a drug is not licensed does not mean it is not safe or suitable for your condition. I hope that helps.
If it's licenced for a different condition, or is approved in another country with good standards, then it is safe to take and info on side effects and common interactions with other medicines can be relied on.
Using drugs off-licence can be for any number of reasons (age as described above, not yet presented for approval for that use, pending approval, effective but not approved by NICE etc)
Is there some sort of support association for the condition? Asking other patients - some of whom will be pretty expert - might help you decide where in the continuum wouid fall this drug for this purpose.
I was given a sleeping tablet as a pain relief for a neck issue, it’s not intended to relive pain and is a sleeping tablet formally.
But it worked and that’s what mattered!!
I had an ectopic pregnancy previously- the standard treatment is methotrexate- widely used but also whilst licenced to treat cancer it isn't actually licenced for ectopics - I went ahead with it
Licensing is so expensive and the same drug can be used to treat lots of things
On the other hand there could be a very good reason why it’s not licensed.
If you tell us the drug and the condition we’ll be able to answer you better.
It's very common and nothing out of the ordinary. Every drug I have had for treating my migraines for example is unlicensed for this condition, that's because they haven't sort a licence for this purpose. I've had blood pressure meds, antidepressants and anti-epileptic drugs. Non of which are licensed for migraine but do work.
I'd happy with doctor 1, recommendation. There maybe other private options but these won't have been deemed cost effective by NICE or they would be avaible on the NHS.
A few months post op, I was experiencing some weird pain and my consultant prescribed me a particular course of treatment. My pharmacist friend told me that it was something that was licensed for the treatment of shingles - which I definitely didn't have. So I don't think it's uncommon.
It's very very common.
Very simply the drug wasn't designed for that use initially however they discovered it works for other things or the prescribing guidelines recommend one thing but the drug is used for another.
In Mental Health it's very very very common.
Anti convulsants used to treat epilepsy are also really good mood stabilisers. That is an off license use.
Some mental health conditions are not recommended treatment with medication so anything prescribed related to that condition is off license use.
Doctors have to put their details across with the script to use it so if it backfires it's on them!
There's a lot of work going on now, looking at existing drugs for new treatments. After all, what is an annoying or unwanted side-effect in one situation might be just what the Dr. ordered in another.
DW has MS, and there's a lot of research into how drugs for completely unrelated conditions might have an effect on that.
Ds has been on off licence drugs for his asthma since he was 2. In his case his asthma couldn’t be controlled with the doses/drugs approved for his age so they had to go off licence to get it controlled.
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