FDA Approves Vogelxo Testosterone Gel Amid Safety ConcernsJune 9, 2014 — The U.S. Food and Drug Administration (FDA) has approved Vogelxo (testosterone gel), manufactured by Upsher-Smith Laboratories and marketed for the treatment of hypogonadism (low testosterone).

Vogelxo is a Schedule III controlled substance because it contains testosterone. The gel will be available in tubes containing 50-mg of testosterone in 5-g of gel. Vogelxo will also be available as a 88-g metered-dose pump in 2-count cartons. Each metered-dose pump delivers 12.5-mg of testosterone.

In recent months, the FDA has approved several new testosterone replacement products, including Aveed and Natesto. Meanwhile, the agency is investigating the heart risks associated with low testosterone drugs. In November 2013, a study published in JAMA found a 29% increased risk of heart attack, stroke, and death among men over 65 on testosterone. Two months later, PLOS One published a study linking testosterone therapy to a doubled risk of heart attack for older men in poor health.

Last week, a panel of federal judges decided to centralize about 100 lawsuits involving AndroGel and other testosterone products into a Multi-District Litigation (MDL) in Chicago, where AbbVie and Abbott Laboratories are headquartered. Lawsuits involving Vogelxo and other testosterone products could potentially be transferred into the MDL.

The companies are accused of spending $80 million in an ad campaign promoting the idea that testosterone gel can treat normal signs of aging, such as fatigue, low libido, loss of muscle mass, and more. Plaintiffs say those ads are responsible for driving $1 billion in AndroGel sales last year.

Need a Texas Vogelxo Lawyer?

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Vogelxo lawyers for a free lawsuit review.