Medicine lists "flu" as side effect?

[AmandaM]

My husband just got a prescription for Singular. We were reading through the inserts and looking at the reported possible side effects and one stood out: flu.

Now I can see reporting flu-like symptoms, but unless there is actual influenza in the pill, how can flu be a side effect?

Do I just not understand how it works?

[LostAngeles]

Googling says it blocks brachioconstriction... bigger air passage allows more flu virii? I'm totally just guessing here.

[Skeptic Ginger]

Actually, the problem is when they collect data to formulate those drug inserts, there likely was the possibility people on the drug had more incidents of either actual influenza or more likely influenza like illness which encompasses a broad spectrum of upper respiratory pathogens.

Rather than do the definitive research to rule this in or out as a risk, often the drug companies just report the finding.

[Criticalist]

Looking through the product information sheet, it says:

"In placebo controlled clinical studies, the following adverse experiences reported with Singulair which occurred in greater than or equal to 1% of patients and at an incidence greater than or equal to that in patients treated with placebo, regardless of drug relationship" and then goes on to list a number of conditions, including trauma, dental pain, and sure enough influenza. Influenza is listed as occuring in 4.2% of patients taking the drug, compared to 3.9% of those taking placebo.

So what this means is they have compared any and all symptoms which have been reported by people taking the drug in clinical trials. This is pretty much anything that anyone feels like reporting, and of course the majority of these things will not be true side effects. The table lists those reported symptoms, which occured in more than 1% of the population and happened more frequently in those taking the drug. They dont provide any statistics to suggest that the differences were "significant" eg unlikely to be due to chance. My guess would be that the difference in the influenza incidence is just due to natural variation, in the same way 1.0% of patients taking the drug were listed as suffering from trauma compared to 0.8% taking placebo. (although the statistics which I am too lazy to do may prove me wrong!)

Bottom line - singulair probably doesn't cause influenza.

[rjh01]

I wonder what the margin of error for the percentages from the above post are? Probably at least 0.5%. That should be listed. The list of side effects are really useless. Should only list ones where they are significantly grater than the placebo group.

[Skeptic Ginger]

I wonder what the margin of error for the percentages from the above post are? Probably at least 0.5%. That should be listed. The list of side effects are really useless. Should only list ones where they are significantly grater than the placebo group.There is a difference between a drug product insert and actual research.

It's really not that big of a deal. It's one reason prescribers generally interpret drug inserts for patients.

[Oliver]

Googling says it blocks brachioconstriction... bigger air passage allows more flu virii? I'm totally just guessing here.


Or the drug may influence another certain immune aspect such as a hormone, protein, glands etc... thus weakening the immune system against flu. It does, however, not mean that the drug does contain the flu itself or so. ;)

[Skeptic Ginger]

Or the drug may influence another certain immune aspect such as a hormone, protein, glands etc... thus weakening the immune system against flu. It does, however, not mean that the drug does contain the flu itself or so. ;)Nor does it mean an actual association exists, only that it showed up in preliminary data.

[AmandaM]

Wow - I had no idea how they actually collected "side effect" data. I mean, at what point do they say "this can't possibly have been related to the use of the drug?" Or do they ever?

If I break my arm while I'm testing the drug, broken bones don't get listed as a side-effect, but if I get diagnosed with strep throat, would THAT be listed?

It doesn't seem like having this information does me any good as a consumer. It also seems counter-intuitive sometimes when you read that the side effect of a headache medicine is ... headache. ?:boggled:

[jasonpatterson]

It doesn't seem like having this information does me any good as a consumer. It also seems counter-intuitive sometimes when you read that the side effect of a headache medicine is ... headache. ?:boggled:

Undoubtedly it was originally intended to be helpful to consumers, but I imagine that it has turned into a liability limiting thing now.

Ever notice how just about all medicines list constipation and/or diarrhea as side effects?

[Eos of the Eons]

Wow - I had no idea how they actually collected "side effect" data. I mean, at what point do they say "this can't possibly have been related to the use of the drug?" Or do they ever?

If I break my arm while I'm testing the drug, broken bones don't get listed as a side-effect, but if I get diagnosed with strep throat, would THAT be listed?

It doesn't seem like having this information does me any good as a consumer. It also seems counter-intuitive sometimes when you read that the side effect of a headache medicine is ... headache. ?:boggled:


I've seen people listed as died in car accidents or in air plane crashes. With some awareness of the process, that skeptigirl was trying to explain, you know it isn't actually attributed to the drug. Drugs are regulated, and this is just part of that process. It's any easy way to tell regulated drugs from unregulated supplements.

[Andrew Wiggin]

If I break my arm while I'm testing the drug, broken bones don't get listed as a side-effect, but if I get diagnosed with strep throat, would THAT be listed?



Breaking a bone while testing the drug would get you listed with the one percent who experienced 'trauma'. They really do list everything. In the cases of a drug that sedates, disturbs balance, or affects judgment, broken bones, deaths from car crashes, and that sort of thing might actually be significant, and they never know for sure what side effects will appear until after the test.

In the case of flu, it's probably not significant.

A.

[Capsid]

I was involved in a clinical trial for a vaccine where one side effect was a gun shot wound. Not me, in case you were wondering.

[Skeptic Ginger]

Wow - I had no idea how they actually collected "side effect" data. I mean, at what point do they say "this can't possibly have been related to the use of the drug?" Or do they ever?

If I break my arm while I'm testing the drug, broken bones don't get listed as a side-effect, but if I get diagnosed with strep throat, would THAT be listed?

It doesn't seem like having this information does me any good as a consumer. It also seems counter-intuitive sometimes when you read that the side effect of a headache medicine is ... headache. ?:boggled:Side effect reports are continually collect regardless of when it occurs. So before a drug is released studies compare the drug to placebo controls. Things which occur in the drug recipients in a greater percent than the placebo group are then reported as potential side effects.

But initial research does not always include large enough sample sizes to determine if results that only differ by small percentages are statistically significant. So a lot of stuff gets listed that may or may not really be a side effect of the drug. If the difference between drug recipient and controls is large, it likely is drug related.

And, some side effects only occur in such a small number of people they don't show up until you release the drug into the market. This is OK. You cannot test every drug on a million people before you market it.

The way we deal with this issue is twofold. One, all unusual or severe reactions a prescriber believes may be related to a drug are typically reported back to the manufacturer. While there is a formal system for vaccine side effect reporting (VAERS), most providers report all serious reactions after a drug is administered voluntarily to the manufacturers.

If one one my patients has such a reaction, I can call the manufacturer and ask if similar reports have been made. There is often unpublished data one can learn by phone about pharmaceuticals.


The second way we deal with potential unknown risks of a newly marketed drug is to prescribe the drug sparingly until it has been on the market long enough to reveal low chance risks. If there is a drug already available for a patient I would not switch the patient to a newer drug that is only marginally better. But for my patient who is not getting better on anything out there, I would give them the new drug.

Eventually enough people get the drug that its safety track record is established and you might switch more patients over to it.

For some new drugs, there is no older alternative. In those cases the patient's need is greater than the unknown risk so you prescribe it in that case.

[AmandaM]

Thank you so much! I had no idea of the complexities of drug trials! This is really interesting! Thanks for taking time out to explain it :)

[Eos of the Eons]

Making a drug ready for market after the testing is even more involved. Matt Fiore wrote an excellent article for SWIFT on that!

http://www.randi.org/site/index.php/swift-blog/661-hiding-homeopathy-behind-real-science.html