Low Testosterone Therapy: Europe’s Drug Agency Reviewing Possible Prescription Testosterone Risks
April 16, 2014
On April 11, 2014, the European Medicines Agency (EMA) announced it is starting a review of testosterone medications. The EMA’s review was triggered by the Estonian medicines agency. The EMA’s announcement comes in response to increasing concerns about possible cardiac side effects of medications containing testosterone, which were prompted by the recent publication of two major scientific studies. According to the EMA, one study linked the use of testosterone to increased risk of heart attack in men over 65 years old and in younger men with pre-existing heart conditions. A previously published study found that men with pre-existing heart conditions who use testosterone medications had a higher risk of heart problems than those who did not use the medications.
U.S. FDA and European Medicines Agency Reassessing Similar Testosterone Therapy Products
According to Bloomberg News, in the European Union (EU), testosterone drugs have been approved in several countries under various trade names and formulations, including gels, patches, and implants. All testosterone medications are authorized nationally, so the safety standards will have to be coordinated across the different national governments of the member states. The EMA’s review is being carried out by the Pharmacovigilance Risk Assessment Committee, which will evaluate the safety issues and make recommendations regarding testosterone therapy. The EMA plans to “review all available data on the benefit-risk balance of testosterone-containing medicines (in men and women), and issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the EU.” The EMA’s announcement echoes the current reassessment of prescription testosterone by the US federal government. On January 31, 2014, the US Food and Drug Administration (FDA) issued a safety alert regarding prescription testosterone medications. The FDA is currently investigating the risk of stroke, heart attack, and death in men who use these medications, which include gels and patches such as AndroGel and Androderm.
Naturally Occurring Decline in Testosterone Levels
In the United States, the FDA approved testosterone only for men with hypogonadism associated with a medical condition. Independent health agencies across Europe, including the MHRA in the United Kingdom, have approved testosterone therapy drugs for similar indications. The referenced condition of hypogonadism is primarily caused by genetic disorders and is marked by a severe lack or complete absence of the testosterone hormone. An article in Forbes noted that testosterone levels in men decline naturally as individuals age and levels drop about 1% each year. According to the Wall Street Journal, prescription testosterone manufacturers are making a profit marketing testosterone therapy drugs to aging men experiencing this natural decline, labeling it “Low T” and telling them the drug will boost their energy, endurance, and libido.
Comparison of Testosterone Prescription Rates for U.S. and UK
A recent epidemiological study in the Journal of Clinical Endocrinology & Metabolism compared the use of testosterone in the United Kingdom to that in the United States. The study was funded by the U.S. National Institutes of Health (NIH) and was completed by researchers at the University of North Carolina at Chapel Hill, Boston University, and the University of Basel in Switzerland. The researchers evaluated commercial and Medicare insurance claims from the United States and general practitioner healthcare records from the United Kingdom for the years 2000 through 2011. In 2000, the population-adjusted rate of testosterone initiation in the U.S. was six times higher than the rate in the UK and rose to 17 times higher than in the UK by 2011. The study authors also noted that Americans with normal or high levels of testosterone were being prescribed testosterone therapy more often than their UK counterparts: “Those with normal or high levels received testosterone in approximately 1% or less of cases in the UK, while the US treated such individuals in 4% to 9% of cases.“ The authors concluded that heavy direct-to-consumer marketing in the U.S. may have led to a much wider interest in testosterone levels and hypogonadism symptoms, resulting in more prescriptions for men with nonspecific symptoms like fatigue combined with normal testosterone levels.
Testosterone Use Increased in Germany
The use of prescription medication to combat symptoms of naturally declining testosterone is currently not as prevalent in some European countries as it is in the U.S., where testosterone is prescribed to three percent of Americans over 40 years old, according to NBC News. But the German weekly news magazine Der Spiegel has noted a concerted increase in marketing of testosterone therapy for ailments referenced as “testosterone deficiency syndrome.” At the magazine’s request, the Scientific Institute of AOK, one of Germany’s largest insurers, analyzed the number of prescriptions issued for testosterone through Germany’s statutory health insurance funds. The analysis found that prescriptions for testosterone gel more than tripled between 2003 and 2011, reaching 390,000 daily doses per year.
Have You Experienced An Injury While Taking Low Testosterone Therapy?
If you or a loved one took prescription testosterone and suffered a cardiovascular injury, such as a heart attack or stroke, you may want to speak with an attorney to learn about your rights. Free and confidential consultations with our personal injury lawyers are available by calling toll-free (866) 981-4800 or filling out the form to your right.