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Warning Issued For Men Being Treated For Low Testosterone

PITTSBURGH (CBS) -- Millions of men are being treated for low testosterone. Prescriptions have doubled in the last four years with sales now reaching $1.6 billion. But now there are disturbing new allegations about a hidden danger.

Ed Downes struggles to put on a jacket. He's partially paralyzed.

"I would never want this to happen to another family," said Kathy Downes, Ed's wife.

She says their world crashed when he had a stroke almost two years ago.

"It's been hard. I can't count on him to do a lot like he used to," said Kathy.

"I walk with a terrible gate, chronic fatigue, chronic pain, shortness of breath," said Ed.

They blame the blockbuster prescription drug AndroGel, which he was taking for low testosterone, or "Low T."

"See, I figured low testosterone would decrease my sex drive, but when I started losing energy and became moody that's when I had an honest conversation with my doctor," said a man in an AndroGel commercial.

KYW's Stephanie Stahl: "They say it's supposed to help in the bedroom."

Ed Downes: "No. That was one of the main reasons why I wanted to use it, and it didn't seem to make much of a difference there at all."

Downes says he was taking medication for hypertension and attention deficit disorder, but was otherwise healthy. Still, feeling the effects of middle age in his late 40s, he asked his doctor for testosterone.

The 51-year-old says he used AndroGel for about two years, and it did give him more energy and muscle mass. Then, out of nowhere, he suffered a stroke.

The FDA is now investigating the safety of testosterone replacement after two studies linked it to an increased risk of strokes, heart attacks and death.

Attorney Scott Levensten, who represents Downes, is planning to sue the maker of AndroGel. He says the warning label fails to warn of heart attack and stroke in any patient.

"Without this warning, you're going to have men suffering strokes and heart attacks around the country not knowing why," said Levensten.

AndroGel's packaging does include a number of warnings, including hypertension as an adverse reaction, and another about blood clots in the legs.

The maker of AndroGel, Abbvie, wouldn't comment on Ed Downes' case, but a statement says in part, the product has "more than 10 years of clinical, safety, published and post-marketing data, with known therapeutic risks well documented in the prescribing labels."

Dr. Laurence Belkoff says when properly used testosterone can be safe and very helpful.

"It has not been proven that there is a direct link with testosterone and cardiovascular disease. It's a phenomenal therapeutic option in the appropriate patient," said Dr. Belkoff.

But Downes thinks patients need to be better warned about potential risks. While still recovering, he's spending more time with his daughters because he's not able to work.

"I just wouldn't want this to happen to any other family, that we had to go through. Things will never be the same, but we're just thankful he's alive period," said Kathy.

While it investigates, the FDA is not telling men to stop using testosterone drugs. If you're concerned, see your doctor.

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