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Low-T Patients Poised To Sue Drug Makers

FORT COLLINS, Colo. (CBS4) - A Fort Collins man is planning to sue the makers of a popular testosterone boosting drug after he suffered a heart attack.

Stephen Nichols, 59, blames his heart attack on the drug Androgel, which was prescribed to him to treat low testosterone, commonly known as Low-T.

(credit: CBS)

Similar lawsuits against the makers of testosterone drugs have already been filed in Illinois and Louisiana, and the FDA is now investigating the safety of testosterone treatments. That comes after recent studies linked it to an increased risk of strokes, heart attack and death.

LINKS: FDA Alert | JAMA Study | UCLA Study

Testosterone replacement has been called a "wonder drug" for middle aged men worried about a decline in their sexual health and energy levels. More than 5 million people in the U.S. are currently taking testosterone.

Dr. Al Barqawi, a urologist at the University of Colorado Hospital, told CBS4 he thinks testosterone drugs are being over-prescribed in part because people are being bombarded by TV ads.

U.S. prescriptions for testosterone therapies have increased more than fivefold in recent years, with sales exceeding $1.6 billion, surpassing sales of Viagra.

"There is a misconception that testosterone is the elixir of life. This fountain of youth that is coming from it. It's not true." Barqawi said.

Low-T is controversial in the medical community because some doctors believe it is an invented condition.

"It is unclear if the symptoms of Low-T are actually symptoms of aging that do not need to be treated," he said.

He says testosterone therapy should only be prescribed to people with severely low testosterone and under constant supervision of a doctor.

In Nichols case, he says he was feeling run down and decided to see his doctor. This former pilot and avid golfer says he was "really tired" and "couldn't get up and walk across the street." A blood test confirmed his testosterone levels were extremely low and he was prescribed Androgel.

Two years later, Nichols suffered a heart attack, but continued to take the testosterone therapy. He says his doctor kept "prescribing it and I kept taking it," until he saw an ad for a law firm warning of potential risks of testosterone therapy.

He called his doctor who told him to stop the testosterone treatments immediately. Now Nichols has signed up to sue the makers of Androgel with Philadelphia based attorney Scott Levensten.

"We think the drug manufacturer kept a secret to protect its blockbuster (drug) about this risk and betrayed patients," Levensten said.

Levensten also represents stroke victim Edward Downes, a 51-year-old Pennsylvania man who says taking testosterone therapy "ruined his life."

Downes says he asked his doctor about testosterone treatments after seeing a TV ad.

"I thought 'Hey, I might feel a little virile and all that,' sounded like a pretty good deal to me."

He said, "I wasn't trying to be Hercules or anything."

After suffering a stroke, Downes walks with a cane and says "taking out the trash is like running a marathon."

Both Downes and Nichols say they aren't filing lawsuits to "get rich." Instead they want testosterone drugs pulled from the shelves.

"I want them to stop prescribing it to anybody and everybody," Nichols said.

Testosterone products like Androgel remain on the shelf as the FDA investigates.

AbbVie, the maker of Androgel, provided a statement that included the following: AbbVie conducts ongoing comprehensive and robust approaches to monitor the safety of our products.

CBS4 also contacted the Low-T Center, a national chain of 48 testosterone clinics, and Medical Director William Reilly, M.D., provided the following statement about the testosterone lawsuits.

We are excited about the FDA's inquiry into alternative testosterone delivery models. Physicians have been administering testosterone injections in cases of medical necessity since the 1950's. Clinical research places the therapeutic benefits of testosterone replacement therapy beyond question, in cases where the treatment is medically appropriate and properly managed. The key, like any treatment is to maintain effective protocols and closely monitor the patient's results, all in conformance with good medical practice.

LINK: Low-T Center Statement

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