Androderm
Controversy has erupted over Androderm and other prescription testosterone treatments, following the release of studies that suggest their use may increase the risk of heart attacks, strokes and blood clots. A growing number of testosterone lawsuits accuse the drug’s manufacturers of concealing this risk, and of engaging in “disease mongering” to drive sales of the medications.
Androderm Lawsuit Reviews
The nationwide law firm of Bernstein Liebhard LLP is now evaluating product liability claims on behalf of men who experienced heart attacks, strokes, pulmonary embolism or deep vein thrombosis while using prescription low-T therapies. To learn more about filing an Androderm lawsuit, please call (888) 994-5118.
What is Androderm?
Androderm is a testosterone patch that is indicated to treat low testosterone (hypogonadism) in men who suffer from either primary hypogonadism or hypogonadotropic hypogonadism. The safety and efficacy of Androderm and other low-T therapies in men with “age – related hypogonadism” have not been established.
Androderm is marketed by Actavis Pharmaceuticals, and was approved by the U.S. Food & Drug Administration (FDA) in 1995.
Testosterone Side Effects
Cardiovascular side effects and complications that may be associated with Androderm and other low-T therapy medications include:
- Heart Attack
- Stroke
- Deep Vein Thrombosis
- Pulmonary Embolism
- Blood Clots
- Death
Androderm Safety Warnings
- January 2014: The FDA launches a safety review of Androderm and other prescription testosterone treatments, amid concerns that the drugs might increase the risk of heart attacks and strokes in certain men.
- June 2014: The FDA orders that new warnings regarding an increased risk for venous blood clots, including pulmonary embolism and deep vein thrombosis, be added to the labels of all low-T therapies, including Androderm. Read More
- March 2015: The FDA orders low-T manufacturers to add new warnings to their product labels regarding a possible association with heart attacks and strokes. The labels must also be modified to clearly state that the drugs have not been proven safe and effective in treating age-related drops in testosterone. Read More
Testosterone Heart Studies
The FDA announced its testosterone safety review in the wake of two studies that raised concerns about the drug’s cardiovascular side effects:
- November 2013: Research that appeared in JAMA suggested that use of low-T therapies was associated with a 25.7% risk of cardiovascular side effects, compared to 19.9% for men who were not on the drugs.
- January 2014: A study published in PLoS One found that men over 65 were twice as likely to have a heart attack if they used low-T treatments, while men under 65 with pre-existing heart disease were three times as likely to have a heart attack if they used the drugs
Testosterone Lawsuit News
- June 2014: A multidistrict litigation has been created for all federally-filed testosterone lawsuits brought on behalf of men who allegedly suffered heart attacks, strokes and blood clots due to their use of Androderm and other low-T therapies. The new litigation will be housed in the U.S. District Court, Northern District of Illinois. Read More
- April 2014: Plaintiffs who have filed testosterone treatment lawsuits over the drugs’ alleged cardiovascular side effects have asked to have all federal cases centralized in a single U.S. District Court. They argue that centralization is appropriate because the lawsuits pose common questions of law and fact, and will ensure efficient management of the litigation and avoid duplicative discovery. Read More
Legal Help for Those Harmed by Androderm
If you or a man you care about suffered a heart attack, stroke or dangerous blood clot while using Androderm, now is the time to ensure your legal rights are protected. To learn more about the growing testosterone litigation, please call (888) 994-5118.
- FDA (2015) “Androderm” http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020489s033lbl.pdf
- FDA (2014) “FDA Drug Safety Communication: FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products” http://www.fda.gov/Drugs/DrugSafety/ucm383904.htm
- FDA (2014) “FDA adding general warning to testosterone products about potential for venous blood clots” http://www.fda.gov/Drugs/DrugSafety/ucm401746.htm
- FDA (2015) “FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use” http://www.fda.gov/Drugs/DrugSafety/ucm436259.htm
- JAMA (2013) “Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels” http://jama.jamanetwork.com/article.aspx?articleid=1764051
- PLoS One (2014) “Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men” http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0085805
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