Natesto
The nasal testosterone spray, Natesto, was approved even as the U.S. Food & Drug Administration (FDA) investigated a possible link between the use of low-T therapy and certain cardiovascular side effects. Since its launch on the market, the FDA has ordered the manufacturers of all prescription testosterone treatments to add new warnings to their labels regarding a potential association with an increased risk of heart attack and stroke.
Natesto Lawsuit Reviews
The nationwide law firm of Bernstein Liebhard LLP is now offering free, no-obligation legal reviews to men who may have suffered a heart attack, stroke, deep vein thrombosis, or pulmonary embolism while using prescription low-T therapy. If you are interested in filing a Natesto lawsuit, please contact our legal staff by calling (888) 994-5118.
What is Natesto?
The FDA approved sale of Natesto in May 2014 to treat adult men who have low or no testosterone due to certain underlying medical conditions. The safety and efficacy of Natesto and other prescription low-T drugs in treating men who are experiencing diminished testosterone levels due to aging has not been proven.
The recommended dose of Natesto is 11 mg administered intranasally three times daily for a total daily dose of 33 mg. Natesto should be administered once in the morning, once in the afternoon and once in the evening (6 to 8 hours apart), preferably at the same time each day.
Side effects that may accompany the use of Natesto include:
- Rise in PSA
- Headache
- Rhinorrhea (condition where the nasal cavity is filled with a significant amount of mucus fluid)
- Epistaxis (bleeding from the nose)
- Nasal discomfort
- Nasopharyngitis (inflammation of the mucous membranes of the upper pharynx, the nasopharynx, or the nasopharyngeal duct)
- Bronchitis
- Upper respiratory tract infection
- Sinusitis
- Nasal scab
FDA Testosterone Warnings
- January 2014: Just months before approving Natesto, the FDA announced it was reviewing the safety of all low-T therapies amid concerns that the drugs might increase the risk of heart attacks and strokes in certain men.
- June 2014: One month after Natesto’s approval, the FDA orders new blood clot warnings for all prescription testosterone treatments, including pulmonary embolism and deep vein thrombosis. Read More
- March 2015: Less than a year after clearing Natesto, the FDA concluded the review announced in January 2015, and orders low-T manufacturers to add new warnings to their product labels regarding a possible association with heart attacks and strokes. Read More
The FDA announced its testosterone safety review after several studies raised questions about the cardiovascular side effects associated with low-T therapy:
- November 2013: A scientific paper published in JAMA suggests that use of prescription testosterone treatments is 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 publishes 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.
Legal Help for Those Harmed by Natesto
If you or a man you care about suffered a heart attack, stroke or dangerous blood clot while using Natesto, now is the time to ensure your legal rights are protected. To learn more about the growing testosterone litigation, please call (888) 994-5118.
- Endo Pharmaceuticals (2015) “Natesto Testosterone Gel” http://www.endo.com/File%20Library/Products/Prescribing%20Information/Natesto_prescribing_information.html
- 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
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