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Michael Castleman M.A.

Warning to Men: Erection Drugs Just Might KILL You

The FDA calls erection drugs "safe." But a recent study shows that's misleading.

Posted Dec 15, 2014

The Food and Drug Administration (FDA), the nation’s drug-safety watchdog, approved the three main erection drugs as “safe.” But are they? Not quite.

According to a recent study of erection medication side effects during the decade from 1998 (the year Viagra was approved) through 2007, Viagra has been implicated in at least 1,824 deaths mostly from heart attacks. Cialis (approved in 2003) has been linked to 236 deaths, and Levitra (2003) to 121. In addition, the three medications appear to have caused or significantly contributed to at least 2,500 nonfatal heart attacks and other potentially serious heart problems, and more than 25,000 other potentially serious side effects, among them: mini-strokes, vision loss, and hearing loss.

So how can the FDA call them safe? And what can men do to protect themselves?

Before the FDA approves new drugs, the agency requires manufacturers to submit safety studies that identify side effects. For erection medications, the studies were reassuring—nothing worse than low rates of minor annoyances:

• Headache: 10-15% (depending on the drug and dose)

• Stomach upset: 4-10%

• Nasal congestion: 2-4%

• Blurred vision: 2-3%

• Flu-like symptoms: 2-3%

But the dirty little secret of safety studies presented to the FDA is that subject pools number just a few thousand. If a drug kills, say, one person in 150,000, that side effect is unlikely to show up during pre-approval trials. But if the drug becomes a hit and millions use it, you’re looking at dozens of funerals.

After approval, with increased use, new side effects turn up regularly. As a result, within five years of drug approvals, the FDA insists that manufacturers expand the side effects and warnings sections of their package inserts for half of new drugs. Erection medications’ official list of side effects has been updated several times as new side effects have turned up.

In 1998, soon after Viagra’s release triggered a worldwide stampede, the bodies started dropping. Turned out that the combination of Viagra and nitrate medication—notably nitroglycerin for treatment of angina—caused a rapid, potentially fatal drop in blood pressure.

Angina is a form of heart disease caused by inadequate blood flow through the arteries of the heart—similar to much erectile dysfunction (ED) which is often caused by inadequate blood flow through the arteries of the penis. The processes that cause these two conditions are so analogous, that doctors consider erection loss a possible early symptom of heart disease. The upshot: Millions of angina sufferers taking nitroglycerin for their heart disease also had ED and tried Viagra. After several hundred deaths, the FDA ordered doctors to stop prescribing Viagra to anyone taking nitrate medications.

Doctors quickly changed their ways. The death rate from Viagra plummeted. And the story disappeared from the headlines. But erection drugs continued to cause problems, and some users continued to turn up dead.

Which is why the recent Ohio State University study is important. The researchers used the Freedom of Information Act to obtain the FDA’s entire catalogue of adverse event reports for erection medications—10 years, 26,451 reports. That’s 220 reports a month, and it’s not a pretty picture. Most disturbing is the steady trickle of serious cardiovascular events and deaths.

I hasten to add that with some 5 million American men taking erection drugs, any individual’s chance of serious side effects or death is tiny. The study’s authors estimate it to be on the order of 0.006 percent, just six in 100,000. Still, 220 reports a month gives one pause.

The drug companies generally pooh-pooh cardiovascular deaths in men taking erection drugs. Look, they say, lots of men with heart disease will die from it whether or not they take erection medication. We wish the two weren’t associated, but that’s all it is, an association. There’s no proof of cause-and-effect.

The drug companies have a point. Associations don’t necessarily imply cause-and-effect.

On the other hand, the FDA doesn’t require adverse-event notification for erection drugs, so the 26,451 reports were submitted voluntarily by doctors and loved ones, typically in cases that were sufficiently unusual for someone to think, This is weird. Maybe the FDA should hear about it. As a result, the FDA learns of only a small fraction of serious side effects. If a guy with a history of heart disease has a heart attack, his wife or girlfriend may not even know he’s been taking an erection drug, and even if they find a bottle in his medicine cabinet, how many would link the two and call the FDA? So the number of serious side effects and deaths is probably higher than documented.

I’m not saying that erection drugs should be avoided. As prescription medications go, they’re fairly benign—but with one big caveat, the unsettling number of cardiovascular problems and deaths. If you’re a man interested in erection medication, here are some suggestions for safe use. Discuss them with your doctor:

• If you take nitroglycerin for angina or any nitrate medication, you absolutely cannot take erection medication.

• If you don’t smoke, aren’t overweight, get regular exercise, don’t drink more than two alcoholic beverages a day, and don’t take drugs to control high cholesterol, high blood pressure, or diabetes, you’re at low risk for cardiovascular disease, and can probably take an erection drug safely.

• But the more risk factors you have for heart disease—smoking, obesity, diabetes, sedentary lifestyle, alcohol abuse, high cholesterol, and/or high blood pressure—the more problematic erection drugs are likely to be.

I repeat: There’s no proof that Viagra et al. increase risk of heart attack and stroke. But if I were at significantly elevated risk for heart disease, I’d use these drugs cautiously if at all. I’d take the lowest dose that did the job. And I’d monitor my reactions carefully. The FDA may call erection drugs “safe,” but with more than 200 monthly reports of side effects (and probably many more unreported), use these drugs cautiously.

Erections are fun, but the fact is, they’re not necessary for either great sex or male orgasm. There are plenty of marvelously satisfying ways for men to make love without an erection, and in an erotic context with sufficient stimulation by hand, mouth, or sex toy, men with semi-erect or even flaccid penises can have marvelous orgasms. For more on this, see my previous posts: Erections After 50 (Oct. 15, 2011) and Great Sex Without Intercourse (Sept. 15, 2014).

Lowe, G. and R.A. Costabile. “10-Year Analysis of Adverse Event Reports to the Food and Drug Administration for Phosphodiesterase Tye-5 Inhibitors,” Journal of Sexual Medicine (2011) 9:265.

Erections matter

” If you don’t smoke, aren’t overweight, get regular exercise, don’t drink more than two alcoholic beverages a day, and don’t take drugs to control high cholesterol, high blood pressure, or diabetes, you’re at low risk for cardiovascular disease, and can probably take an erection drug safely.”

The problem is that those reasons, and anti-depressants, are the reasons men have erectile dysfunction (plus prostate cancer treatments, which the ED drugs don’t generally help with).

It seems very difficult for a man to enjoy sex without an erection – yes, I know it’s theoretically possible, but there is so much emotional baggage that mostly they just avoid sex altogether – or they will have sex to satisfy their partner, but that sure gets tiresome for the partner (at least it does for me, because a big part of my pleasure is knowing I’ve pleased the man).

Plus, and this is difficult for many women to admit, but an erection is a big signal, a big turn on for women. It says, I want you. It says, you excite me. YES, I KNOW THIS ISN’T REQUIRED. I’m just saying that I personally miss it, and I know other women aren’t too happy about ED either.

My advice is for men to take better care of themselves if they want to be able to keep having the sex they envision. Stay in shape, keep off the pounds, improve cardio function, quit drinking and smoking, and be wary of medications. If you are diagnosed with prostate cancer you better to A LOT OF HOMEWORK.

Indeed, the same thing

Indeed, the same thing occurred to me as I read the article. If you don’t smoke, exercise, normal weight, etc., well, then you aren’t likely to need Viagra in the first place!! These days doctors regard ED as a possible early sign of cardiovascular disease, which means anyone needing Viagra is very likely not in the greatest of health. I think the ED commercials area bit misleading when they show a 50-year-old guy who appears to be active and in ideal health — the very kind of guy least likely to need an ED drug. They try to sell the concept that a normal 50-year-old in perfect health needs an ED drug, and that’s BS.

As for the statistics of the dangers, out of 5 million men using ED drugs, assuming an average lifespan of 74 years you would expect an average of 5,000,000/(74×12) = 5,631 deaths/month for all causes. And many of those would be due to heart attacks. And you say only 220 are “linked” to an ED drug? Frankly I don’t even know how you “link” those deaths if thousands would be dying of heart attacks anyway. Unless you could demonstrate that there tends to be an additional 220 deaths among those 5 million men than another group of 5 million men with the same statistical health profiles as a group.

Any man can develop ED

While men at risk for cardiovascular disease are at higher-than-usual risk of ED, any man can develop it. After around age 50, even men who are in excellent shape notice a loss of erection firmness and by 60, most men in excellent physical condition have trouble raising and maintaining erections.

I’m not calling ED drugs necessarily hazardous. Just saying that they may not be as safe as the commercials claim.

wow,you're clueless! A guy

wow,you’re clueless! A guy can have ED no matter how great of shape he’s in.Here you are making the assumption that the reason a guy has ED is because he doesn’t take care of himself-you’re an idiot! Oh and you need to be wanted and need a guy to have a hard on so YOU can feel validated lol! There are 1000’s of reasons a guy can develop ED and most of them are beyond a man’s control,YOU need to do ALOT of homework ! Next.

Actually, not clueless at all!

What I said was that men in good health are less likely to need Viagra, regardless of age. And that is a fact, period.

If you understand how to read, that means that SOME men who are in excellent shape still need Viagra.

Again, ED, especially in men who are not in advanced age, is considered a POSSIBLE sign of cardiovascular disease, and for good reasons. And for those who can’t read the word is POSSIBLE, not DEFINITE. If you do not know the difference, please consult a dictionary.

Also, I’m a man, not a woman writing. So you got that wrong too.

I think "Submitted by

I think “Submitted by Anonymous on December 15, 2014 – 2:57pm.” was referring to me, the very first poster.

I was careful to clarify in my post that those are my PERSONAL feelings. I guess some people can’t respect that. I don’t care.

Well, if it makes you feel

Well, if it makes you feel any better, I’m a man and I love what you wrote:

“Plus, and this is difficult for many women to admit, but an erection is a big signal, a big turn on for women. It says, I want you. It says, you excite me. YES, I KNOW THIS ISN’T REQUIRED. I’m just saying that I personally miss it,”

I wish my wife felt as you do. Unfortunately, she’s not interested in sex and couldn’t care less whether I had an erection or not. In fact, she’d rather I not have one as she considers it a pain in the neck to have to “deal with”.

I guess that’s the great irony. Guys with ED are married to women like you. While guys like me who never once had ED in a 30-year marriage, have wives who have no interest at all.

"A guy can have ED no matter

“A guy can have ED no matter how great of shape he’s in.”

Well, true, he *can*, but he probably won’t.

"A guy can have ED no matter

One of the anonymouses in here wrote:

“A guy can have ED no matter how great of shape he’s in.”=

Well, true, he *can*, but he probably won’t.

This is flat-out wrong. In fact by the time men hit their 50s, they probably WILL start to have ED problems, no matter what kind of shape they are in. If you do not smoke, have no vascular diseases and are not overweight, those things help. But regardless, the human body just does not function in its 50s like it did when it was 20.

I am there, and am doing this. I am one of those guys. Normal blood pressure, slim, never smoked, never used recreational drugs, never on any medications for anything my whole life. My ancestry is one of men living easily into their 90s

And still. I use Viagra now.

I do not expect to drop dead. I am one of the millions and millions of men in their 50s and 60s who are in excellent health who benefit from this drug.

spoken like a disrespectful

spoken like a disrespectful whore for a woman

Oh, here we go again. The

Oh, here we go again. The guy with the small mind who thinks bandying about words like “whore” carries a lot of weight and convinces people. All it shows is the poverty of his intellect. It’s apparently his most effective argument — simply calling someone a “whore”.

Hopefully this poster will at some point advance beyond the silly name-calling I first heard on the playground in 4th grade.

I want to try

I agree that most ED is a sign of health issues. Even having low testosterone will cause ED. A man shouldn’t wait until he has problems to seek help. We all should learn how to take better care of yourselves and the younger you learn to the better.

Now with that thought being said, I am a man without any ED issues. I have a desire to just try one of these meds one time to experience it. From what I hear though it is a horrible experience if you have no issues.

One experience

I don’t know if it’s typical, but I know of one young man who took ED pills (probably more than the recommended dosage) to see what would happen. He ended up with an erection lasting 24 hours, at which point he went to the hospital. They tried a few simple things that didn’t work. Only after an injection of something did he go back to normal. He apparently managed to avoid permanent injury somehow.

If you already easily have erections, I’d stay away from the drug. If you can’t resist, start with a very small dose.

Longer Term Use

More and more young men as young as 20 are using Viagra or other ED drugs. I doubt they drugs were designed or tested for such long term use. What will be the complications for these young men as they get old?

I exerciser every day for more or less the last 35 years ran in marathons and in very good shape for my early 50’s ( never smoked ) and i have started having occasional ed issues, not full blown . my thought on it is whether it’s to my life style or not that cause it, i will take ed medication when needed ( a special night planned )

i feel the risk is worth the quality of life for me and my wife for having a good sex-life.

I think it is a bigger risk getting in your car everyday to drive to work or the store everyday. everything in life carries a partial of risk.

Peyronie's disease, which

Peyronie’s disease, which affects up to 10% of men of all ages, often causes ED. It is no fun at all seeing your erection go from rock hard to flaccid within weeks & it staying that way indefinitely.

Given the choice between trying a potentially fatal drug that restores erections and living the rest of their life feeling like a vital part of them has died, most men would take a chance on the drug.

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About the Author

Michael Castleman, M.A., is a San Francisco-based journalist. He has written about sexuality for 36 years.

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