This is not true. Side effects are not binary (you get them of you don’t).
A manufacturer could say “you run the risk of temporary paralysis of no longer than 1 year” (based on observations to date), then patient has paralysis lasting 2 years so they sue because “manufacturer understated risk and severity of paralysis”.
I suspect they won't change their ways unless they're sued over it. It would definitely be something I'd consider if I was prescribed something that hurt me further. (Of course not much you can do if it's a known and disclosed possible side effect...)
See my edit. You're trying to use the definition of long term side effect to show that we need long term studies before we can deem things safe. But that doesn't follow. If the prevalence of some potentially chronic condition is low enough after a month to be safe, that it might be even safer doesn't really matter.
Right like to recap but remove the word "long term" entirely, you said that there might be issues that develop after years without warning. I said that no that's not possible, stuff can't develop suddenly after even just a month or so, because the mechanisms don't exist. You then cited an example of something that developed in under a month or two as a counterexample. When I put it that way, it's clear that it isn't actually a counterexample.
When it comes to prescription drug liability claims, it doesn't really matter whether the use was off-label. The key factor is whether harmful side effects were properly disclosed on the product label. Where manufacturers really get hit with huge verdicts is when they knew (or should have known) about a side effect but failed to put it on the label.
Pharmaceutical products in the US that have unexpected side-effects can cause their owner to be sued into oblivion, and even incredibly rare side effects are likely to manifest if a large population is taking them. (Also, the population at large does not understand statistics & probability.) Look at the history of Thalidomide, that's where a lot of precedents were set.
This puts certain categories of drugs (anything for pregnant women, nootropics for people without alzheimers, etc.) in the "too risky to bother" category.
I don't know if it's the law here in France or just nice manufacturers, but I've seen side effects broken down by occurence rate ( 1 in 100,000: X, Y, Z; 1 in 1,000,000: A, B, C, etc.) multiple times.
> Is common sense that if you drive a machine harder than its specifications then it will break a lot sooner.
It is also common sense that if you do something, and you do it a lot over a long time with a lot of people, and you don't see anything bad happening, nothing bad is probably going to happen!
Which is better, a universal weak probabilistic statement made in ignorance of specifics, or a narrow statement about one thing based on specific evidence?
> Also, many of these drugs take years for the effects to show up.
Again, provide numbers. I will grant that 'some' - as in, a non-zero number - drugs have long-term side-effects. However, I dispute 'many', or 'most'. There are many thousands of drugs which the FDA has approved, most of which do not turn up with horrible thalidomide-like long-term side-effects.
Oh, I fully agree there is risk of long-term side effects and that trials are crucial. But was just curious if there had been any cases of things like that getting through trials and other safeguards.
Can’t find it now because google seems to have down ranked it. There have been cases of medication having very long term side effects which were not caught during trials. I’m thinking specifically of something that caused birth defects.
I don’t think it is wise to claim so much authority as you have when it is literally impossible to have FULL confidence. Are you going to take responsibility for the 1 in 1 million who reads your comments and goes on to suffer an adverse reaction?
So how can there be claims like ‘there are more side effects’ without any data?
You don’t get to make claims and then require someone else to provide data to disprove them. If you make the claim you have to provide the data yourself.
A manufacturer could say “you run the risk of temporary paralysis of no longer than 1 year” (based on observations to date), then patient has paralysis lasting 2 years so they sue because “manufacturer understated risk and severity of paralysis”.
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