Prominent Consumer Advocacy Group Calls for FDA to Implement Stronger Labeling Requirements for Testosterone Drugs

Public Citizen, a prominent consumer advocacy group, has called on the Food and Drug Administration (FDA) to require drug manufacturers to add a bold warning label, also known as a "black box", to popular testosterone drugs for men as mounting evidence demonstrates that use of testosterone drugs can increase the risk of heart attack, stroke, and death. Specifically, Public Citizen is requesting that the FDA require that all testosterone replacement products have prominent "black box" warnings to alert physicians about an increased risk of heart attack, stroke, and death in patients who use the treatment. Public Citizen's call for a "black box" warning comes on the heels of the FDA's announcement last month that it was reviewing the safety of testosterone drugs such as AndroGel in light of the two recent studies published in JAMA and PLOS One that demonstrated higher rates of cardiovascular problems in men using testosterone replacement drugs. In fact, Public Citizen says that studies published as early as 2010 should have prompted FDA action to require these warnings.

Public Citizen's outreach to the FDA is important because it seeks to protect consumers by requiring testosterone products manufacturers to explicitly warn of injuries the drugs increase the risk of, including heart attack and stroke. These are precisely types of injuries our clients have suffered, including the clients whose complaints we recently filed in federal court in the Northern District of Illinois. Morelli Law Firm adamantly supports Public Citizen's position that the FDA should require manufacturers to include a "black box" warning on testosterone replacement drugs.

If you or a loved one has suffered a heart attack, stroke, or blood clot following testosterone use, contact Morelli Law Firm immediately or complete a FREE consultation form.

Categories: Testosterone Lawsuit
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