logo
Google Reviews Logo

317.636.6481

One Indiana Square, Suite 1400 Indianapolis, Indiana 46204

Make a Payment
logo
CONTACT US
CALL US
  • Home
  • Firm Overview
  • Our Attorneys
  • Practice Areas
    • Pharmaceutical Drug & Medical Device Litigation
    • Personal Injury
    • Sexual Abuse
    • Class Action
    • Medical Malpractice
    • Eminent Domain
    • Family Law
    • Business Services, Real Estate & Business Litigation
    • Bankruptcy, Creditor’s Rights, & Commercial & Business Law
    • Appellate Law
  • Firm News
    • News & Announcements
    • Alerts
  • Resources
    • Video Library
    • Blog
  • Contact Us
Google Reviews Logo

317.636.6481

One Indiana Square, Suite 1400 Indianapolis, Indiana 46204

Make a Payment
  • Home
  • Firm Overview
  • Our Attorneys
  • Practice Areas
    • Pharmaceutical Drug & Medical Device Litigation
    • Personal Injury
    • Sexual Abuse
    • Class Action
    • Medical Malpractice
    • Eminent Domain
    • Family Law
    • Business Services, Real Estate & Business Litigation
    • Bankruptcy, Creditor’s Rights, & Commercial & Business Law
    • Appellate Law
  • Firm News
    • News & Announcements
    • Alerts
  • Resources
    • Video Library
    • Blog
  • Contact Us

Home » FDA Requires New Testosterone Warning for Heart Attack and Stroke

FDA Requires New Testosterone Warning for Heart Attack and Stroke

Testosterone Injury Lawsuits

The FDA issued a new labeling requirement on March 3, 2015, for manufacturers of prescription testosterone products to inform healthcare professionals and patients about a possible increased risk for heart attacks and strokes in patients taking these drugs. The FDA also included a caution that prescription testosterone products are only approved for men who have low testosterone levels caused by certain medical conditions.

This requirement comes after the FDA conducted its own investigation into the safety of these drugs and met with the Drug Safety and Risk Management Advisory and Bone, Reproductive and Urologic Drugs Advisory Committees in September 2014 to discuss testosterone replacement therapy drugs and cardiovascular risk.

Testosterone Blood Clot Warning

This new warning for heart attack and stroke is the second prescription testosterone warning issued by the FDA. In June 2014, the administration warned doctors and patients of an increased risk for venous blood clots, also known as deep vein thrombosis (DVT), pulmonary embolism (PE), and venous thromboembolism (VTE).

The market for prescription testosterone has been growing aggressively since 2001 when drug makers coined the term “Low T” or low testosterone and urged men who were tired, overweight, or suffered from low libido to speak with their doctors about Low T. Annual revenues for prescription testosterone topped $2.4 billion in 2013 and are expected to reach $3.8 billion by 2018 according to statista.com. Popular makers of prescription testosterone drugs include:

  • AndroGel — Abbott Labs (AbbVie)
  • Axiron— Eli Lilly
  • Testim/ Testopel— Auxilium Pharmaceuticals
  • Androderm— Actavis (formerly Watson Pharmaceuticals);
  • Android— Valeant Pharmaceuticals NA
  • Depo-Testosterone— Pfizer Inc.
  • Fortesta— Endo Pharmaceuticals
  • Striant—Auxilium Pharmaceuticals

Testosterone Injury Lawsuits

Men who have taken prescription testosterone and suffered heart attacks, serious blood clots—like pulmonary embolism and DVT, and strokes have filed lawsuits against manufacturers of these drugs. If you or someone you know has taken prescription testosterone and suffered a serious injury, contact us. Our product liability attorneys have talked with hundreds of men who have taken Axiron, AndroGel, Androderm and other prescription testosterone products. Our attorneys are experienced in litigating claims against large drug manufacturers and can provide you with a free case evaluation.

One Indiana Square Suite 1400
Indianapolis, Indiana 46204

Copyright ©  Cohen & Malad, LLP. All rights reserved.

Disclaimer  |  Privacy Policy

 

Schedule a free consultation Today
  • This field is for validation purposes and should be left unchanged.

Schedule a free consultation Today

  • This field is for validation purposes and should be left unchanged.

ALERTS

Former NFL Players Still Have Time to Claim Concussion Settlement Funds

It’s not too late for former National Football League players to claim their funds from the concussion .. Read More

SEE ALL ALERTS

In the News

Indiana Legal Services and Indiana State Bar Foundation Receive $90,000 donation from Cohen & Malad, LLP Class Action United Way of Central Indiana’s Center for Working Families Receives $32,000 from Cohen & Malad, LLP Settlement Funds Indianapolis Neighborhood Housing Partnership Receives $32,000 from Cohen & Malad, LLP Settlement Funds
READ OUR NEWS