What is a Complication or “Adverse Event”?
A patient recently reported that she experienced insomnia “complications” after starting her osteoporosis medication. She found people on the internet who had experienced the same problem after taking this medication. She even found insomnia on the manufacturer’s website listed as an “Adverse Event”.
What is an “Adverse Event”?
The total number of women in the FDA approved study of this medication was 7762. Insomnia is listed because over 2% of patients taking the medication (126) or the placebo (think sugar pill) (122), reported it. 126 is more than 122. That makes it an “adverse event”. Had the numbers been reversed insomnia would not have been listed at all.
Other more common Adverse Events listed include Back Pain at 1347 vs 1340, and Musculoskeletal Pain at 297 vs 291. Joint Pain was also common, but did not make the list because a few more patients on the placebo reported it than did patients on the real medication. This does not make sense to me, but government rules are rules.
In all these instances there is no real difference in the numbers of each type of adverse event between the group of women on the real medication and the women on the “sugar pill” or placebo. Therefore, the medication is not believed to cause these problems. However, under FDA rules, when at least one more patient on the real medication reports an issue, it must be be listed as an Adverse Event.
Was my patient’s insomnia caused by her osteoporosis medication? Possible but not likely. And what caused the insomnia in the 122 women who had it after receiving the placebo in the trial?
Jay Ginther, MD