I have a chronic illness and am on lots of prescriptions. Every Rx I take has a risk of death along with other things like brain clots, brain infections, etc. Does that mean someone in the trial became affected with one of these issues?
In: Other
Possibly yes, though those side effects might have been discovered during animal testing, or after the drug was on the market and in use.
In worse case scenarios, yes, but in most cases they are just able to see what kind of not so serious side effects the drugs cause in people, and then from that can see what kinds of effect that actually has on the body, and what more serious problems could stem from it.
For example if a drug as a side effect raises your blood pressure, they could infer that it might cause heart problems for people that are already close to having heart problems.
Look up thalidomide and tretinoin babies, drug companies have always been greedy and gone to great lengths to cover up side effects which has been devastating for the victims. It’s a bit more regulated now but most doctors I know are very very cautious about drugs
That is an interesting question, but no that simple to answer. It depends on the country legislation as well. But as a general rule, a drug, to be released for the public, needs to spend a very long time in test to make sure that is safe for use. A new drug with a new active compound takes between 10-15 years in research, a new drug but with an already tested active compound can be done approved in a couple of years.
With that in mind, there are a lot of trials and tests, they first use *in vitro* tests (that is, tests made in cells),after that the can go to *in vivo* tests (tests made in animals, usually we start with lab rat or mice, than to bigger animals like apes or other mammals). Only after that they can start tests in humans, and even here we start with a small sample of volunteers and every test the drug passes it goes to a bigger sample size.
Along all these rounds of test scientists gather information on what went wrong and in what test and in what frequency. So they gather all the possible side effects that occurred in those trials (especially with humans), in some countries they also need to disclose possible side effects that happened with live subjects.
Now it is good to know, while in human trials, even though drug companies try to minimize and control the experiment as much as possible, anything that happens to those people while in trial needs to be reported as possible side effects. So sometimes, especially when you have a big sample size ‘odd’ things might happen to some of the volunteers, things that scientists are pretty sure it wasn’t the drug, but they need to disclose anyway (unless they can prove it wasn’t the drug or any interaction that the drug may have caused).
What /u/kleytondread said is the biggest reason – that adverse events during the drug trials have to be reported even if they appear to be unrelated to the drug itself.
Sometimes drugs do have significant risk of major adverse events. And in a very few cases, those drugs slip through the cracks. These days, that generally happens because the adverse event happens at a low enough frequency that it cannot be distinguished from the baseline risk with a small sample, but once the drug is used by hundreds of thousands or millions, it becomes evident. This is what happened, for example, with Vioxx.
decades ago, this sometimes happened because the initial testing regime was itself not adequate. That’s what happened with thalidomide. Fortunately, thalidomide was caught in the United States and not introduced to wide youth, but it was used widely in other places, like West Germany. In that case the issue was that drug testing regimens were far less controlled and they did not require the drug to be tested in pregnant women. as a matter of fact, FDA policy at the time strongly discouraged testing drugs on women of childbearing age because ironically the risk to them and their fetus was perceived to be high enough that they should be excluded. thalidomide, unfortunately, was not tested in pregnant women but was widely prescribed to them to combat morning sickness. its serious impacts on the development of the fetus were not realized until tens if not hundreds of thousands had already been affected.
these days, although it is not technically a requirement, the FDA makes it a policy to not approve drugs for use if they have not been tested in the target consumer. So if your drug is only tested on adult men, it will only be approved for use in adult men, and not for usin women or children. As a matter of fact, the vast majority of drugs are now tested in women because for the vast majority of drugs, women would be part of the patients to whom the drug could be prescribed. there are a few examples where women are not included in drug testing. For example, some recent hemophilia drugs have not been tested in women because it is tremendously rare for women to have hemophilia. However, the drug is actually approved for use in women even though it wasn’t tested in women. Why?
the answer is that, and this is something you should keep in mind when thinking about prescription drugs, the FDA does an assessment on every drug to determine if the drug is both safe and effective. safe and effective is not an absolute standard, where a drug can only cause adverse events in no more than, say, one in 10,000 patients. Instead, the risks observed in the trials, both the nature and frequency of those risks, are weighed against the benefits of the drug in the proposed patients. Drugs that treat serious illnesses which can result in death do not need to be as safe as drugs which are intended for widespread use in patients who are not expected to die in the near-term. The FDA allows riskier drugs, with potentially worse side effects, because if the drug helps the patient (is effective), using it will still improve the condition of most patients even if a small, but not tiny, number do suffer serious adverse events. Warfarin is a blood thinner that is an example of one of these drugs. It can cause severe bleeding, and does so in about 1 to 3% of patients treated with warfarin every year. But it is used to treat blood clots, like those that cause pulmonary embolisms and strokes. Those clots represent a far higher and immediate danger to the patient, and as a result the relatively high risk of serious side effects is acceptable because overall the drug provides a benefit.
Latest Answers