by Neil Bauman, Ph.D.
© June, 2010
Olmesartan is moderately ototoxic—it causes hearing loss, tinnitus, balance problems including vertigo in numbers of people, but that appears to be the least of your worries if you take this drug. Our drug watchdog, the FDA, in their latest email bulletin (1), reports:
The “FDA is evaluating data from two clinical trials in which patients with Type 2 diabetes taking the blood pressure medication, Benicar (Olmesartan), an angiotensin II receptor blocker, had a higher rate of death from a cardiovascular cause compared to patients taking a placebo.”
Notice that! Olmesartan, a high-blood pressure medication, causes death more often in those taking it, than in those who have high blood pressure but don’t take it!
This report admits, “An unexpected finding observed in both trials was a greater number of deaths from a cardiovascular cause (heart attack, sudden death, or stroke) in the Benicar-treated patients compared to placebo.” (1)
Now the reason you supposedly take a high blood pressure medication is to prevent heart attacks, strokes and sudden death—yet this drug apparently actually causes them—based on the results of not just one, but two, long-term studies.
After hearing this, any normal person would conclude that taking the drug could be dangerous to their health and quit taking it, yet does the FDA reach the same conclusion? Not on your life (and it is your life they are talking about)!
Here’s what they say. The “FDA’s review is ongoing and the Agency has not concluded that Benicar increases the risk of death.” (Yet the two studies they reviewed showed just the opposite.)
So what is their recommendation? You’re not going to believe it. (Remember, this is your tax dollars at work.)
The “FDA currently believes that the benefits of Benicar in patients with high blood pressure continue to outweigh its potential risks.”
What I want to know is what benefits are they talking about—since the supposed benefits of high-blood pressure medication are to reduce the risk of heart attacks, strokes and sudden death—and these studies clearly show that taking this drug results in more heart attacks, strokes and sudden death!
As I have emphasized many times before, you must always consider all the side effects of drugs, not just their ototoxic side effects—although I typically only talk about the ototoxic side effects—because if a drug kills your body, your ears won’t work any more either!
(1) “FDA MedWatch – Benicar (Olmesartan) Ongoing Safety Review”. June 11, 2010.
I have been taking olmarsartan medomoxomil for about 2 months and had a cold last weekend and have lost about 50% of my hearing and my voice and have had a very sore throat ever since first taking it. Is this likely to be permanent or may it return if I don’t take Olmarsartan any more?
Hi Janet:
Olmesartan can certainly cause hearing loss, but I think it is much more likely that the cold clogged up your middle ears and Eustachian tubes resulting in a temporary conductive hearing loss. However, another strong possibility is that the cold virus got into your inner ears and caused a sensorineural hearing loss that will very likely prove to be permanent.
So you have three possibilities that could have caused your hearing loss. If you have a hearing test and it shows you have a conductive loss, then likely your hearing will return when the cold goes away and the fluid in your middle ear and Eustachian tubes drains out. If it shows you have a sensorineural loss, then the progosis is not very hopeful.
Getting off the Olmesartan is probably a good idea in any case as studies show it apparently does more harm than good.
Cordially,
Neil
I took Benicar 40 mg 4x day for 9 years and suffered no ill effects that I know of. However I was not taking it for HBP.
Hi Mary:
You’re one of the lucky ones. Not everyone is so fortunate when they take Benicar. To be sure, some people don’t have any side effects, but there is risk involved.
Cordially,
Neil
I am suffering horribly from tinnitus and occasionally Vertigo. Taking Olmesatan medicine 40mgs once a day. If I stop taking it how long will it take for the tinnitus to get better and hearing come back to a better place??
Hi Bradley:
There are no guarantees that your hearing will come back and your tinnitus go away. Once you stop taking the Olmesartan, I’d give it a month. The hearing you have then is probably the hearing you’ll have going forward. If your hearing come back, you could expect your tinnitus to fade away. If your hearing doesn’t come back, then your tinnitus may be permanent. If that happens, you can do things to habituate to your tinnitus so it doesn’t bother you whether you hear it or not.
Cordially,
Neil
The FDA report you listed was updated with a much more comprehensive set of data in June 2014: https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-review-cardiovascular-risks-diabetics-taking-hypertension-drug
I have been on 20mg Olmesartan for about 15 years and had no ototoxic or cardiac related concerns. Only in the past year, in my mid-50’s, have I started experienced steady tinnitus. I note others of my age range in my workplace also suffer from similar symptoms but are not on any similar medication.
Hi Bill:
Thanks for the updated report. But I notice some stuff in it that hides the true negative side effects I brought out in my article. In order to make this drug “look better”, they compare results including mortality to other drugs, rather than to a true placebo.
When comparing one drug to another to see mortality figures, all you end up doing is seeing which drug causes more people to die. What you really want to know is whether more people die from taking the drug than from doing nothing (not taking ANY drug). Unfortunately, too much medical research is done this way now. It’s hard to believe how many studies use another drug for comparison, rather than a true placebo. Thus the results, although they look so good are really not the truth at all.
Cordially,
Neil
do you know of any patient that has stopped olmesartan, and their ringin in the ears went away?
Hi Rudy:
I don’t have any specific reports, but that is not unusual as few people tell me the results of getting off drugs, but one person noted that his tinnitus gets louder about 4 hours after he takes Olmesartan. So that indicates it is not necessarily permanent.
Cordially,
Neil
Dear Dr, Bauman,
I am concerned. I have had several rings over my tinnitus since taking four generic 20 mg tablets of olmesartan medoxomil and two 20mg tablets of non generic Benicar. I have stopped them.. Could have been from high BP or l-arginine /magnesium supolements. I have not tested but hearing seems okay, Can this short time do damage that is correctable or too short and no worries?
Hi Michael:
If you haven’t noticed any continued tinnitus and no hearing loss since you stopped taking the drugs, then I think it’s “no worries” for you.
Cordially,
Neil