Public Citizen Asks FDA to Add Black Box Warnings to Testosterone Containers

Public Citizen, a group that advocates for the rights of consumers, recently sent a written request to the FDA asking it to place warnings on labels of testosterone medications.  The petition was dated February 25, 2014 and sent directly to the FDA.  It asked that the FDA place what is known as a ‘Black Box’ warnings on the labels of this medication.  These warnings are designed to overtly warn users of medications that they could be dangerous.  The specific dangers that have been linked to testosterone replacement therapy drugs include heart attacks, strokes and death.

That was not all that Public Citizen requested of the FDA.  In addition to the warning, Public Citizen asked the FDA to ask manufacturers of these medications to send ‘Dear Doctor’ letters to medical professionals.  These letters would warn physicians of these potential testosterone side effects.  Public Citizen also asked that the FDA-approved Medication Guide be updated to include the warnings regarding the use of testosterone replacement therapy medications.  Finally, the group asked the FDA to hold off on the approval of a new testosterone replacement therapy medication absent the adoptions of the steps previously mentioned.

Public Citizen has long been a voice for consumers and it has attempted to take action against pharmaceutical companies, medical device companies and other corporations that manufacture products used by consumers.  This action is one that has generated some attention from the media, as it follows an announcement by the FDA from January 31 that the agency is beginning to investigate the situation surrounding testosterone replacement therapy medications.

The FDA has taken this step because it has received information including the results of studies regarding the potential dangers of undergoing testosterone replacement therapy.  These studies have indicated that men who use these drugs face a much higher risk of heart attacks, strokes and death than those who do not.  Some feel that the potential risks faced when using these medications outweigh the potential benefits derived from these drugs.

In addition to the steps taken by the FDA and Public Citizen, testosterone replacement therapy lawsuits have been filed in different parts of the United States.  One of the most common products named in these lawsuits is AndroGel, but it is hardly the only medication that has drawn scrutiny after patients have allegedly suffered side effects.  Those lawsuits are still in their early stages, but some legal experts feel that these claims are only the beginning.  That’s because millions of men have undergone testosterone replacement therapy, or TRT.  Therefore, the number of men who could be harmed is enormous.

If you or someone you love has undergone testosterone replacement therapy and you believe that you have experienced side effects, you need to take action to defend your legal rights.  Contact the testosterone replacement therapy lawyers at Parilman & Associates to schedule a free initial consultation.  You can do so either by emailing the firm or by calling 800-800-DRUG.