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The upswing in testosterone lawsuit filing and research reports warning of fatal heart attack risks associated with Low-T drugs have woken up medical regulatory authorities. The European Medicines Agency has called for limiting prescription of testosterone drugs to the treatment of verified hypogonadism and avoiding using them to benefit lifestyle. In September, two FDA committees made similar recommendations that forced the US federal regulator to seek additional data on the testosterone blood clotting side effects.
The EMA warning came after its Pharmacovigilance Risk Assessment Committee called for regular safety review and monitoring of testosterone therapy heart attack risks. “Testosterone levels naturally fall somewhat with age, but restoration of these levels in healthy older men is not an authorized use of the medicine and manufacturers should update the product information in line with the latest evidence and to provide warnings about those who might be at an increased risk of heart problems,” reads the EMA’s statement issued on November 21.
“The product information should make it clear that testosterone should only be used when an abnormally low level of the hormone has been confirmed by signs and symptoms and appropriate laboratory tests,” says the agency. The assertion comes in the backdrop of allegations that manufacturers are resorting to direct-to-consumer marketing and advertising their drugs as an effective mean to counter falling energy and sex drive due to the aging process.
Though the European agency did not reach any conclusive evidence on the association between testosterone therapy and heart attacks and blood clots, it suggested continued “research, monitoring, and regular safety review” of such adverse events. The regulator also advised men with heart, liver, or kidney disorders to avoid testosterone drugs.
FDA Calls For Safety Review
Two FDA panels, Drug Safety and Risk Management Committee and Bone, Reproductive, and Urologic Drugs Committee, met in September to assess testosterone side effect injury complaints. After consulting with various experts, the two panels suggested regulatory direction to force manufacturers for “additional trials to evaluate the side effects of testosterone drugs on mens’ hearts.”
Held in the backdrop of rising number of testosterone lawsuits, both meetings called for efforts to prevent Low-T drug use for “life style reasons” and restrict their prescription to actual illness. It called for strict measures to reduce use of the medications to overcome natural drop in testosterone level as the age progresses and even suggested civil fines on drug makers for noncompliance.
Testosterone Therapy Side Effect Risks
With a majority of over three million men using Low-T drugs to meet lifestyle needs, testosterone attorneys expect a large number of side effect injury lawsuits in the coming years. Research studies indicate a higher chance of adverse cardiovascular events in men receiving testosterone boosters despite having normal levels or without proper diagnosis of required medical condition. While these drugs are overprescribed, over 90 percent users are using these medications without proper test readings.
The most common injuries associated with testosterone therapy include,
- Blood clots
- Heart attack
- Stroke
- Pulmonary embolism
- Wrongful death
- Metabolic disorder
- Kidney and liver problems
In February 2014, the New York Times made a startling claim that manufacturers had suppressed information related to testosterone therapy heart attack side effects for over a decade. A 2013 report in the Journal of American Medical Association attacked Low-T drug makers for “selling diseases” through advertisements “designed to convince men that they suffered from low testosterone” even if there was no required medical condition.
Testosterone Lawsuit
Over 200 testosterone lawsuits have been centralized at an Illinois federal court for pretrial consolidations. The first Androgel lawsuit bellwether trial is expected to start in the second half of 2016. While researchers continue to identify and evaluate potential risks associated with testosterone therapy, attorneys specializing in drug injury litigations are busy evaluating prospective claims.
If you are victim of similar injures or suffered adverse events linked to Low- T drugs, contact us or call on 1-800-632-1404 for evaluation of your potential testosterone lawsuit by our experienced drug injury lawyers.
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