UPDATE!
Be sure to read MD’s comments (below) before using FactMed to assess the side effects of whatever med you’re curious about. Try to find the information published by your medication’s maker — if you have a generic Rx, you usually can find a source on the net that will tell you the brand name if you enter the generic name.
Every now and again, you need a source for side effects of medications that is NOT a woo-woo naturopathic site like LiveStrong or any of the myriad sites of the various quacks who try to convince you that their snake oil is better than researched, tested prescription drugs. WebMD always comes up relatively high in a list of search results, and sometimes the Mayo Clinic will have a page describing the uses and potential side effects of various nostrums. The Mayo is reliable enough as a reference, but WebMD has occasionally been questioned.
I recently came across a site called FactMed. It’s a searchable database based on “more than 18 million FDA adverse drug reports for 20,000 different pharmaceutical products.” If you explore around in there, you find a search engine that will let you enter a drug and a specific ailment that you suspect might be a side effect.
Results show the proportion of patients reporting side effects who reported THAT side effect. So, if 100 patients reported that they’d had some side effect of a given med and 5 of them said the med gave them a roaring headache, you would be able to see that 5% of people who had some effect had reported “roaring headache” as the problem. It also shows you the proportion of ALL medicated patients reporting that as a side effect, and it provides a graph showing the proportion of physicians who reported that they highly suspected the med was a cause, that they thought it was a “likely culprit,” or that they thought a connection was highly unlikely.
This is extravagantly useful information. Even though, yes, correlation is not causation, FactMed at least provides some quantitative data to help you assess whether some symptom might be attributed to a drug or combination of drugs you’re taking, and it gives you some credible ammunition when you need to discuss any such issue with your doctor.
The cardiologist and I have been trying to figure out what caused the episode of presyncope (near-fainting) that occurred while I was flying westward across a major surface artery at 50 mph a few weeks ago. Since it was accompanied by a spate of heart palpitations, we of course have suspected a cardiac issue. But so far he has been unable to find any indication of a heart problem. Even my blood pressure, a subject docs love to harp upon, is well into the normal range.
Consequently, he has lashed me up in a Holter monitor — a device that listens to your innards 24/7 — and asked me to wear it for a full freaking MONTH!
This is making me unhappy, partly because it’s very hard to find any clothing that you can wear around such a thing without looking like Frankenstein’s monster, but more to the point because the cables they tape to your chest irritate the perennially sensitive mastectomy scars. These cannot be avoided, because they stretch from armpit to armpit. The discomfort is annoying during the day and makes sleeping almost impossible.
So I intend to get out of it, but to do so wish to explain a) why I’m not doing this and b) why I think it’s reasonable to believe the pseudoephedrine (Sudafed) pill I dropped that morning on top of a full pot of strong black coffee brought all this on.
And lo! Here it is, right in the FactMed database:
This stuff doesn’t just cause presyncope: it actually causes people to lose consciousness:
Proportion of pseud. patients reporting loss of consciousness as side effect: 4.6% [Holy sh!t! That’s almost 5%!]
Proportion of all medicated patients reporting loss of consciousness as side effect: .32%
Number of patients reporting side effects from pseudoephedrine: 999
As for heart palpitations…interesting:
Proportion of pseud. patients reporting palpitations as side effect: 3.0%
Proportion of all medicated patients reporting palpitations as side effect: .33%
If a medication has a weird, rare side effect, I invariably experience it. For godsake, if 5% of patients experience syncope after taking this drug, I am extremely lucky I didn’t actually pass out at the wheel and cause a wreck.
Three percent for the palpitations makes it a bit of a longer shot…but again, given my sensitivities to all drugs, prescription or over-the-counter, it strikes me as not all that unlikely that whatever already causes the occasional spates of palpitation could be kicked up by a drug that wires me to the teeth under the best of circumstances and that may cause me to faint.
The sample of about a thousand people isn’t huge, but it’s respectable.
So here’s what, in the self-diagnosis department: I feel enough confidence that whatever brought this on was not a true cardiac issue that I’m going to throw over the electronic traces and return the Holter monitor. I don’t think it’s worth irritating the scars, which are already uncomfortable enough, thank you, by having tubes rubbing on them all day & all night for a full month and by applying allergy-inducing stickum to the skin near them.
It may annoy the doc, but at least I’ll have a little evidence, based FDA reports, to make my case.
I pulled this from http://factmed.com/study-pseudoephedrine-causing-LOSS%20OF%20CONSCIOUSNESS.php for pseudoephedrine:
“Reports of pseudoephedrine causing LOSS OF CONSCIOUSNESS: 7
Reports of any side effect of pseudoephedrine : 162
Percentage of pseudoephedrine patients where LOSS OF CONSCIOUSNESS is a reported side effect: 4.3210%”
At best the last statement is misleading, and at worst is factually incorrect. I could not find the size of this trial, but 7 out of 162 patients reporting any side effect reported loss of consciousness. Based on that information we can say 4.3210% of patients reporting a side effect reported loss of consciousness as the side effect. One would presume that not every patient in the study reported a side effect, and thus the proportion of pseudoephedrine users reporting loss of consciousness would be much smaller.
Hmmm…. OK. So, at that page, where it cites a population of 999, what do you suppose that figure is supposed to mean? I imagined it meant they included 999 people who had side effects in general, and the “loss of consciousness” bunch was a subset of that group. English major math strikes again?
Doing a little more digging, it looks like the site is aggregating FDA Adverse Event reports in which consumers (or sometimes doctors) can report side effect events to the government. It doesn’t look like the site is pulling data from the drug trials that are performed before drugs are approved and released. So it’s one thing to know we’re not crazy, and other people may be experiencing the same side effect, but I’m not so sure we can use the data on the site to quantify the percentage of people using the medication who experience that side effect.
I wouldn’t chalk it up to English major math. I’d chalk it up to needing and English major to edit their site content for clarity. I would interpret the site as saying there are 999 reported instances of side effects for this medication. Of those 999 instances, XX% of them were for loss of consciousness. In statistics talk, our sample population is users reporting side effects (not users of the drug), and because of this we can only infer our results to all users reporting side effects of the drug.
Good insights. Another issue, too, is that if these are mostly self-reported there’s no way of knowing whether the events reported are actually related to the drug or to some other factor.
Drugs.com, which I think is reporting the information you find in the manufacturer’s printed circular, lists tachycardia, palpitations, arrythmias, dizziness, and headache. That pretty well matches the palpitations, dizziness, and headache that occurred, but does not explain the episode of presyncope.
Presyncope is not the same as “loss of consciousness,” of course. But it strikes me as verging on loss of consciousness. There may be no connection: I’ve had a couple of near-fainting incidents before, the first at the age of about 17. For one there was a reasonable explanation; for the other, not so much. The one that occurred in my early 30s could possibly have been influenced by an allergy drug: by then, I was married and my husband, who had pretty bad hay fever, had prescription-strength chlor-trimeton and pseudoephedrine, which I used to take when I was feeling allergic. It’s not outside the realm of possibility that I could have taken one of his pills and not made the connection between that and the presyncope-like episode.
At any rate, an arrhythmia surely could cause presyncope. If Sudafed brings those on, it’s reasonable to make a connection. That also is an inference, not solid, reproducible proof, though.
My thought is ….ya might want to let the Doc know you’ve decided to forgo the Holter. My experience has been when you don’t do as Docs prescribe they tend to get agitated….some more than others. The really good Docs get REALLY ticked….IMHO….. Aaaand the fact he wants this on you for a whole month …. hmmm…. sounds serious….just something to think about.
As for drug interaction, it seems the medical profession is just now taking this seriously. But on the down side…..if one more person tells me how ibuprofen is destroying my liver….I think I’ll go crazy….
Yah, I see he’s sent a message through his dratted online thing, which I’ll have to hassle to get into.
If he thought it was serious, he didn’t say so explicitly. His reasoning was that it would be hard to see this if it happens about once every 15 years. He was hoping he could capture some record of an episode. In fact, he told me he couldn’t find anything wrong and felt the blood pressure was presently not a problem.
But I really don’t want to wear one of those things for a month. Besides the inconvenience and difficulty of finding something to wear that you can hook it to (the sleeve thing they gave me that’s supposed to hook to a belt does NOT hook — its snap thing is too small & tight to go over any but the thinnest belt, and it can’t be slid over a belt, waistband, or belt loop: you have to thread a belt through it. The only belt I have that will fit into it is too short for me in my current fat state, and so I have to cinch it too tight, which is pretty damn uncomfortable. The irritation of the mastectomy scars is certainly not going to get better over time — it was already so uncomfortable it was keeping me awake at night, and over the course of a week or two could be expected to make things very uncomfortable.
If I’m going to die, welll…frankly, I guess I’d rather drop dead than suffer the way my mother did. My father suffered, too: from heart failure. He told me — several times — that if he’d known how much he was going to suffer after his heart attack, he would never have called for help.
Ibuprofen can do a job on you if you drink alcohol when you’re taking it. It’s a bad idea to drink while taking ANY kind of drug, Rx or OTC.
In my case, I seem to be unduly sensitive to various drugs — this started in infancy, when I almost died from a reaction to a sulfa drug, and now that I’m old it’s getting worse. I no longer can take aspirin, acetaminophen, ibuprofen, and many antibiotics that used to have no adverse effects. Sudafed (pseudoephedrine) wires me to the teeth, and if I take it after noon, it WILL keep me awake at night. I’ve literally had one of the ex’s Rx Sudafeds cause insomnia that lasted through the entire night.
Which brings us back to Sudafed: the fact that for years the stuff has caused hyperactivity and insomnia leads me to suspect a connection between the morning’s pill and, an hour or two later, the faint spell and dizziness.
I don’t know Funny….of course you are ultimately the “master of your destiny”. BUT I can certainly understand the use of the Holter. Used correctly, this should provide a “snap shot” of your cardio-vascular over the 30 day period. This could very well provide insight to something serious OR put your mind at ease. Sorry to hear you have pain and discomfort. Perhaps the Doc’s office has some type padding or alternatives to help….but you have to ask..
I’m not a big drinker….and thankfully enjoy reasonably good health. I am able to take aspirin and ibuprofen to take the edge off the aches and pains. Pretty sure it’s not a good idea to drink when taking Sudafed…
Well, my mind isn’t that uneased, since I’m used to this stuff. It’s worth noting that I’ve done the Holter monitor before. It was before the surgery, so it wasn’t actually painful. It showed exactly nothing.
And the present cardiologist has said a) palpitations won’t kill me and b) he believes there’s not a thing wrong with my cardivascular system. So I’m not that scared. If I believed this was something separate from a drug reaction, I would be concerned enough to want to wear thing thing…although I think a month is way beyond the pale.