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?

How Safe is “Safe”?

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%

• Flushing: 2-11%

• Back pain: 2-6%

• 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.

Nitrate Nightmare

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.

26,451 Adverse Events

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.

Prudent Use

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.

Great Sex Without Erections

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).

Reference:

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.

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