IBJNews

Testosterone-replacement rival of Lilly's Axiron draws lawsuits

Back to TopCommentsE-mailPrintBookmark and Share

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.

ADVERTISEMENT

Post a comment to this story

COMMENTS POLICY
We reserve the right to remove any post that we feel is obscene, profane, vulgar, racist, sexually explicit, abusive, or hateful.
 
You are legally responsible for what you post and your anonymity is not guaranteed.
 
Posts that insult, defame, threaten, harass or abuse other readers or people mentioned in IBJ editorial content are also subject to removal. Please respect the privacy of individuals and refrain from posting personal information.
 
No solicitations, spamming or advertisements are allowed. Readers may post links to other informational websites that are relevant to the topic at hand, but please do not link to objectionable material.
 
We may remove messages that are unrelated to the topic, encourage illegal activity, use all capital letters or are unreadable.
 

Messages that are flagged by readers as objectionable will be reviewed and may or may not be removed. Please do not flag a post simply because you disagree with it.

Sponsored by
ADVERTISEMENT

facebook - twitter on Facebook & Twitter

Follow on TwitterFollow IBJ on Facebook:
Follow on TwitterFollow IBJ's Tweets on these topics:
 
Subscribe to IBJ
  1. I think the poster was being sarcastic and only posting or making fun of what is usually posted on here about anything being built in BR or d'town for that matter.

  2. Great news IRL fans: TURBO the IMS sanctioned movie about slugs running the Indy 500 has caught the Securities and Exchange Commission because Dreamworks had to take a $132MILLION write down...because the movie was such a flop. See, the Indy/IMS magic soiled another pair of drawers. Bwahahahahahaha! How's CARTOWN doing? HAHAHAHA...Indy is for losers.

  3. So disappointed in WIBC. This is the last straw to lose a good local morning program. I used to be able to rely on WIBC to give me good local information, news, weather and traffic on my 45 minute commute.Two incidents when I needed local, accurate information regarding severe weather were the first signs I could not now rely on WIBC. I work weekend 12 hour nights for a downtown hospital. This past winter when we had the worst snowfall in my 50 years of life, I came home on a Sunday morning, went to sleep (because I was to go back in Sunday night for another 12 hour shift), and woke up around 1 p.m. to a house with no electricity. I keep an old battery powered radio around and turned on WIBC to see what was going on with the winter storm and the roads and the power outage. Sigh. Only policital stuff. Not even a break in to update on the winter storm warning. The second weather incident occurred when I was driving home during a severe thunderstorm a few months ago. I had already gotten a call from my husband that a tornado warning was just southwest of where I had been. I turned to WIBC to find out what direction the storm was headed so I could figure out a route home, only to find Rush on the air, and again, no breaking away from this stupidity to give me information. Thank God for my phone, which gave me the warning that I was driving in an area where a tornado was seen. Thanks for nothing WIBC. Good luck to you, Steve! We need more of you and not the politics of hatred that WIBC wants to shove at us. Good thing I have Satellite radio.

  4. I read the retail roundup article and tried Burritos and Beers tonight. I'm glad I did, for the food was great. Fresh authentic Mexican food. Great seasoning on the carne asada. A must try!!! Thanks for sharing.

  5. John, unfortunately CTRWD wants to put the tank(s) right next to a nature preserve and at the southern entrance to Carmel off of Keystone. Not exactly the kind of message you want to send to residents and visitors (come see our tanks as you enter our city and we build stuff in nature preserves...

ADVERTISEMENT