[sub]unfortunately you can’t search for “flu,” so I don’t know if this has been asked before[/sub]
If you pay attention to various drug commericals when they list the possible side-effects, several list the flu.
Why? Are they trying to suggest that the drug makes you more susceptible to getting the flu, or that the drug actually causes you to get it? If it’s the latter, how is that possible? If it’s the former, why not just add a couple of words to make it clear that your risk is just higher?
In clinical studies using the drug, a significant number of patients getting the drug developed the flu. That’s it. No link has been proven, no causation is inferred, it’s a possible side effect, and they are obligated to tell you so.
Just to elaborate on what Nametag has already said. When a Clinincal Study is preformed, there is a portion called “Adverse effects”. All complaints that a subject has during the study falls under this category.
So if a subject is being studied for 6 months, and gets sick with flu in this period (whether or not it is related to the treatment), it is filed as an adverse effect. Thus flu is listed as a possible side effect.
I was always under the impression that this was just them being lazy and the side effect was actually “flu like symptoms”.
Actually, only those symptoms that are signifiantly higher in the experimental group compared to the control are listed. It should at least be very suggestive that the medicine causes the side effects.
I’ve not seen the flu listed as a SE, but I guess that makes more sense.
PC
Not in the clinic I worked at PosterChild. All reactions were listed as AEs whether or not related to treatment. In fact, if a patient was injured in a car wreck while being treated topically for acne, it would be an AE. Keep in mind that in a double blind study all AEs are reported, treatment group or not, due to the blinding.
It was not my place to determine if the AE was related to treatment. That would be at the disgression of the Invesigator. However, the FDA require that all AEs be reported to them. Thus, in an NDA if the flu is present in signifcant numbers it would need to be presented as a possible side effect.