The U.S. Food and Drug Administration (FDA) is warning doctors against over-prescribing testosterone-boosting drugs for men saying that these popular treatments have not been established as a safe or effective means to improve common age-related issues such as low libido and fatigue. According to a report in The Wall Street Journal, the agency has said that drug manufacturers must explicitly state in their labeling and promotions that the drugs, now taken by millions of American men, are only approved to treat low testosterone levels caused by injury or disease, not normal aging.
Serious Side Effects
The FDA issued an alert stating that testosterone supplements may increase the risk of heart attack, stroke and other cardiac problems. Drugmakers must add information about these potential risks to their prescribing labels and conduct a long-term study to further examine the issue, the agency said. This recent FDA action follows years of aggressive marketing by drug makers such as AbbVie and Eli Lilly for new gels, patches and injections, which offer relief from low testosterone or “Low-T” and allay other symptoms common among aging men including sexual problems and low mood.
Safety advocates say the drug industry has been successful in convincing millions of men that taking testosterone therapy can cure their aging problems. The consumer advocacy group, Public Citizen, petitioned the FDA last year to add a boxed warning to testosterone drugs about heart disease risks. But the FDA rejected that petition in July saying that there was not enough evidence to require such a warning.
Requirements for Manufacturers
FDA officials say they have put this alert out after consulting published studies and expert input from an Advisory Committee. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment. Based on its findings, the FDA is requiring label changes for all prescription testosterone products to reflect the increased risk of heart attack and stroke associated with testosterone use.
In addition, the agency is requiring manufacturers of approved testosterone products to conduct a well-designed clinical trial to more clearly address the question of whether there is an increased risk of cardiac problems. If you experience symptoms of heart attack or stroke such as chest pain, shortness of breath, trouble breathing, weakness in one part or one side of the body and slurred speech, it is important that you seek medical attention right away. Your physician will be able to tell you if your symptoms are linked to the use of testosterone supplements.
If You Have Suffered Side Effects
If you have experienced severe side effects as a result of taking testosterone therapy, you may be eligible to receive monetary compensation for your losses including medical expenses, lost wages, permanent injury, disability, pain and suffering and emotional distress. Drug manufacturers have a responsibility to test their products before selling them to consumers. They also have a responsibility to warn consumers about all potential side effects and complications that could arise so that consumers can make an informed decision about their treatment options. An experienced Rhode Island defective drug lawyer can help victims and their families better understand their legal rights and options.