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Testosterone-replacement rival of Lilly's Axiron draws lawsuits

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Abbott Laboratories and AbbVie Inc., the company it spun off last year, hid the dangers of using the testosterone replacement drug AndroGel, five men claim in lawsuits.

Their complaints, filed in federal court in Chicago Tuesday, came four days after the U.S. Food and Drug Administration said it will re-examine the safety of testosterone replacement drugs after two studies showed a higher risk of heart attacks and strokes in men who use them.

The market for testosterone replacement drugs, which include AndroGel and Axiron, made by Indianapolis-based Eli Lilly and Co., is worth $1.6 billion annually.  Lilly is not named in the lawsuits.

The men range in age from 50 to 63, according to their complaints. Three claim they had heart attacks after they started using AndroGel, and a fourth said he had a stroke. The fifth man said he had a mini-stroke.

Abbott and AbbVie “deceived potential AndroGel users by relaying positive information through the press, including testimonials from retired professional athletes” and statistics suggesting a widespread need for the drugs, “while downplaying known adverse and serious health risks,” according to the complaints.

The men accuse Abbott, which marketed the drug from 2010 through 2012, and prescription drugmaker AbbVie of concealing knowledge that AndroGel had a “serious propensity” to harm.

“Abbott separated its research-based pharmaceutical business into a new public biopharmaceutical company,” Scott Stoffel, a spokesman for Abbott Park, Ill.-based Abbott Labs, said. “The U.S. commercial rights and associated responsibilities for AndroGel passed to AbbVie.”

AndroGel is FDA-approved for adult men with low or no testosterone, David Freundel, a spokesman for North Chicago-based AbbVie, said in an e-mailed statement. Known risks are “well documented” on the prescribing label, he said.

Each complaint was filed by the same two law firms, Alton, Ill.-based Simmons Browder Gianaris Angelides & Barnerd LLC and Morelli Alters Ratner LLP in New York. Their clients are seeking unspecified damages.

A study released in November of more than 8,000 men treated in the Veterans Health Administration found testosterone therapy raised the risk of heart attack, stroke and death by 29 percent. Testosterone worsens sleep apnea and is linked to atherosclerosis and coronary plaque, the study found without identifying why.

Prescriptions for the supplements rose more than fivefold, to 5.3 million, in 2011 from 2000, authors of the study said. The products are only FDA-approved for men who lack or have low testosterone levels in conjunction with a medical condition, the agency said.

The FDA advised patients to talk to their doctors.

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