FDA Issues Warning to Males: Research Links Low-T Treatment to Increased Risk of Adverse Side Effects

Testosterone is a natural male hormone, and as men age their testosterone levels (t-levels) begin to decrease. Numerous factors can influence the decrease in testosterone levels, however low t-levels are often associated with medical conditions including testicular failure caused by genetic issues, cancer and chemotherapy.

Testosterone therapy is often used to remedy male hormonal issues-specifically for men who wish to build greater muscle mass, reduce body fat, and improve health and sex drive. The U.S. Food and Drug Administration has approved hormonal therapy as a beneficial treatment for patients suffering low t-levels as a result of coinciding medical issues, however it has not approved testosterone therapy as safe for men without an existing medical condition. Testosterone replacement is typically administered in the form of prescription transdermal gels, creams, pellets, patches, and injections. Common testosterone therapy products include: Androgel, Andoderm, Axirom, Bio-T-Gel, Foretesa, and Testim.

Despite numerous studies and tests by the FDA and private pharmaceutical companies proving the effectiveness of testosterone replacement therapies, recent research suggests there may be dangerous side effects for those patients using this type of hormonal treatment. In fact, many common testosterone therapies have been linked to increased rates of heart attacks, strokes, cardiovascular problems, sleep apnea, increased blood platelets, atherosclerosis and coronary plaque, and even death by as much as 30%. In spite of these potential dangerous side effects, selling testosterone replacement products has become a $1.6 billion industry for pharmaceutical companies, and many physicians have prescribed testosterone replacements to nearly 3% of American men aged 40 and older.

Not surprisingly, testosterone therapy lawsuits have appeared more frequently as male patients have begun reporting injuries shortly after they begin treatment. On January 31, 2014, the FDA released a statement warning of the potential complications associated with low-T treatment, and that they would be conducting an investigation into the reported adverse side effects.

While the FDA is still in the midst of researching and investigating the potential harmful side effects of testosterone therapy, many patients who have been already affected may wonder what their next step should be and who is liable for their injuries. Like any company, pharmaceutical corporations as well as doctors who prescribed the medication, have the liability of ensuring that their products are safe for consumption and that these medical treatments do not pose an unhealthy risk to their patients. When failing to ensure their products are safe, it is the drug companies’ responsibility to compensate victims and families for their injuries and suffering.

At the law offices of Altman & Altman, our experienced Boston Drug Injury Lawyers have decades of experience handling all types of drug injury cases. If you suspect that you have become ill or have been injured as the result of a defective medication, you may be entitled to receiving financial compensation from the pharmaceutical company who manufactured that medication. For nearly 50 years, our team of lawyers has helped Massachusetts victims and their families recover millions of dollars in personal injury settlements and verdicts. Call our office or contact us online for a free initial consultation and case evaluation to determine whether you qualify for a drug injury lawsuit. Our attorneys are available twenty-four hours a day, seven days a week, to answer any questions that you might have, and we take all personal injury cases on a contingency basis: that is, we charge no fee unless you recover. Moreover, if illness or injuries make travel to our office difficult or impossible, our attorneys are more than happy to meet you at a location convenient for you.

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