A consumer advocacy group has petitioned the U.S. Food and Drug Administration (FDA) to add black box warnings to “Low T” therapies that may soon face testosterone lawsuit litigation, according to Reuters.com.

The February 25th report indicates that the organization, Public Citizen, has asked regulators to mandate stronger labels on AndroGel and other medications, given their possible association with strokes, heart attacks and other cardiovascular injuries.

In its request, the organization said that certain “Low T” treatment therapies are often prescribed to treat low libido, fatigue depression and decreased muscle mass—symptoms normally associated with aging—and that 25 percent of patients given the drugs were not administered blood tests to determine if their levels were abnormally low.

14 Studies Highlight Testosterone Heart Attack, Stroke Risks

Public Citizen also points to more than a dozen studies conducted over the past 20 years that note a “highly significant” risk of cardiovascular problems in men taking testosterone therapies. Out of 27 studies released in that time, these 14 studies were not funded by pharmaceutical companies, according to the agency.

Public Citizen’s call for black box “Low T” warnings comes roughly a month after the FDA issued a Drug Safety Communication that raised awareness on the possible risks associated with AndroGel and other hormone-raising drugs. According to a federal notice on January 31st, regulators vowed to conduct a safety review of testosterone treatment therapies, in which they would investigate their alleged association with heart attacks and other life-threatening injuries. This connection has not been confirmed, the FDA pointed out.

Earlier in January, the medical journal PLoS One published a study involving testosterone therapies that found men over the age of 65 to be at a doubled risk for heart attack within the first 90 days of treatment. Younger men with a history of heart disease were shown two or three times more likely to experience this side effect, research indicated.

These findings, coupled with more than 13,000 “Low T” scripts written each year, underline the need for black box warnings, according to Public Citizen.  “Each day of delay of the black box warning ensures much more exposure, too often for men who cannot benefit from the drug but will only be exposed to its risks,” its senior advisor added.

Filing a Testosterone Treatment Lawsuit

If you experienced a stroke or heart attack after taking a “Low T” treatment, contact our Firm to file a testosterone treatment lawsuit. Our attorneys can be reached at (877) 779-1414.

Published February 26, 2014 by