FDA Approves Vogelxo Testosterone Gel Amid Safety Concerns

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.

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