Low-T drugs are potentially dangerous to patients; the risk is under investigation by the FDA.
It sometimes seems like the vast array of available medication offers a panacea for every health problem. For men suffering from low testosterone levels, testosterone replacement through newer medications may seem like the answer. Unfortunately, so-called low-T drugs are turning out not to be a magic pill because of the potential for dangerous side effects.
In fact, lawsuits have been filed around the country in state and federal courts alleging that low-testosterone drugs have caused serious heart problems, blood clots and even death. Many federal cases have been consolidated in multidistrict litigation in the U.S. District Court for the Northern District of Illinois.
According to the Mayo Clinic, testosterone is a male hormone that regulates sex drive and sperm production, as well as improving bone density, fat distribution, red blood cell creation and muscle health. Lower-than-normal levels of testosterone production happen naturally with aging and from hypogonadism, an illness in which the testicles do not produce normal levels of the hormone.
Low-testosterone symptoms are real and disturbing:
- Mental and emotional challenges like problems with confidence, concentration, memory or depression
- Sleep disturbances and low energy
- Problems with sexual functioning
- Increased fat
- Decreased muscle mass and strength
- Gynecomastia or tender breasts
- Body hair loss
- Hot flashes
It is therefore understandable why men with low testosterone would be interested in low-T drugs, offered in gel, injection, pellet or patch forms. However, Mayo Clinic on its website warns that taking testosterone supplements for low levels caused by aging is not "currently advisable," which is the position of the U.S. Food and Drug Administration.
The FDA weighs in
The FDA is actively investigating the safety of low-testosterone therapy after disturbing findings of two studies pointed to the potential for an increase in the risk of serious, even fatal, heart problems from taking low-T drugs. In January 2014, the agency issued a Safety Announcement to this effect, followed by a June 2014 requirement that the associated manufacturers include general label warnings of the increased risk of venous blood clots from the therapy.
From a legal standpoint
In the meantime, lawsuits alleging injury and death from low-T drugs continue to be filed. For example, a January 2015 suit in Georgia state court alleges that the plaintiff, a man in his early 50s, experienced a stroke after using a low-T drug in gel form. He claims that as a result he has ongoing health problems, financial and earnings losses, medical expenses, emotional suffering and more. The lawsuit brings claims against the manufacturers for consequential and punitive damages, legal fees and costs for:
- Failure to warn of potential harm from the "unreasonably dangerous" drug
- Negligence, especially regarding marketing, branding and failing to warn of potential danger
- Breach of implied and express warranties
- Fraud, including concealing information about product safety findings
- Negligent misrepresentation of risk to the public and to treating doctors
- Strict products liability for design defects that made the medications unreasonably dangerous
- Negligence per se for not adhering to federal safety regulations
- And more
Any Californian who has been injured from taking testosterone-replacement therapy or whose loved one has died from it should speak with an experienced litigation attorney to understand potential legal rights and remedies, including a possible lawsuit. In Santa Ana, the law firm of Callahan & Blaine stands ready to discuss low-T claims with injured men and their families from Orange County and across the state.
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