MIAMI (CBSMiami) — For millions of men trying to fight the effects of aging, there’s a drug that claims to make you stronger, smarter, and more virile but is it worth the risk?
An Androgel commercial and website encourage men to try testosterone replacement drugs.
“I thought well it might be something good for me,” said Edward Downes. “So with that ya know I decided why not give it a shot.”
But after about two years of using Androgel, 51-year old Downes had a stroke, which he blames on the drug.
“I was in a lot of pain, dizziness, confusion,” said Downes.
He’s still struggling to recover and now plans to sue.
Scott Levensten is Downes lawyer. “We believe there’s an egregious failure to warn in the package insert, in the television advertising and had Mr. Downes known of the risk of heart attack and stroke, he never would have taken this product.”
Androgel defends its product saying it has “more than ten years of clinical, safety data.” And “the known therapeutic risks are well documented in prescribing labels.”
CBS4 News found that Androgel product information does mention blood clots and hypertension as side effects.
Recent studies have found that Androgel and other testosterone products doubled the risk of heart attack in men over 65 and in younger men with a history of heart disease possibly due to increased production of red blood cells.
“For the men who qualify, giving them testosterone has had a remarkable changes in their life,” said Dr. Paul Savage.
“It’s not a super-drug. It needs to be carefully given to the appropriate patient,” insisted Dr. Daniel Yadagar, a cardiologist. He urges caution with hormone replacement therapy.
“I’m looking at the other cardiovascular risk factors. Is this patient diabetic? Is this patient smoking, overweight and try to work on those modifiable risk factors,” said Yadagar.
“I want them to stop prescribing it to anybody and everybody,” said Stephen Nichols, who used testosterone replacement therapy for years, even after he had a heart attack.
“He kept prescribing it and I kept taking it,” said Nichols.
Legal experts are calling for everything from placing warning labels on the box to pulling the product completely.
Besides Androgel, there are at least eight other products named in lawsuits. The FDA has issued a statement about testosterone drugs saying it is now going to investigate the cardiovascular risks but it has not recommended that people stop using the products.