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FDA Requires More General Warning Regarding Potential Cardiovascular Problems on Testosterone Treatment Drugs

June 25, 2014

The FDA recently announced that they are now requiring a change in the warnings on testosterone products such as Androgel and Androderm. These new warnings are required by law to be more general and warn users of the risk of blood clots. Prior to this announcement, testosterone replacement therapy drugs were only required to include warnings related to polycythemia, a medical issue that occurs due to an abnormally high red blood cell count and that has been linked to testosterone therapy.

This new requirement comes after testosterone therapy treatments were linked to a higher incidence of heart attack, stroke, and other potentially deadly serious cardiovascular problems that are a result of blood clots. Before, companies were only required to include a warning about polcythemia, which although serious, was very specific to certain individuals. The new warning will allow doctors and their patients to better assess whether or not testosterone treatments are the right course of treatment given an individual’s own medical and family history of cardiovascular issues. Unfortunately, the requirement comes after hundreds of men have already faced serious health problems or even death as a result of testosterone therapy treatments that they might have otherwise elected not to use. 

Legal Commentary
From a civil standpoint, our firm has represented numerous individuals and families who have become victim to testosterone therapy and its dangerous side effects and the following psychological trauma. If you or a loved one has experienced any of these side effects you should contact one of our attorneys as soon as possible. A successful civil claim pursued against the responsible party will ensure the victims are not burdened with costly medical expenses, and will hopefully compensate them for their pain, suffering, and lost wages for time missed from work. Further questions can be directed to the Fears | Nachawati Law Firm by emailing the lead testosterone therapy lawyer, Majed Nachawati at, or by calling our office at 1.866.705.7584.

About the Author
Majed Nachawati is a preeminent Pharmaceutical Products Liability Lawyer with a focus on representing AndrGel and other similar testosterone therapy victims and families harmed by dangerous drugs on a nationwide basis. Mr. Nachawati has resolved numerous cases through trial and settlement that have resulted in seven and eight figure confidential settlements. He is on the Grievance Committee for the State Bar of Texas. He is licensed to practice before the Supreme Court of Texas and Arkansas, and is in most federal courts in the nation and holds specific licenses in the Northern, Southern, and Eastern Districts of Texas. Mr. Nachawati is a member of the Board of Directors of the Texas Trial Lawyers Association, the Board of Directors for Public Justice, a Leaders’ Forum and PAC member of the American Association for Justice. Mr. Nachawati has been recognized as a Super Lawyer in Texas Monthly Magazine for the past four consecutive years for legal excellence, in connection with pharmaceutical injury cases. Mr. Nachawati is also a member of The Million Dollar Advocates Forum. Mr. Nachawati can be reached by email at or by calling 1.866.705.7584.​




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