FDA Changes Testosterone Product Labeling
This is Michael Brady Lynch, Lead Trial Attorney for The Michael Brady Lynch Firm.
The FDA has approved new labeling for all prescription testosterone products. The new warning will alert prescribers to the abuse potential of testosterone along. Additionally, it will detail several serious side effects from using this class of drug. These side effects can be deadly causing either heart attack or stroke.
A growing number of men have been experiencing a heart attack or stroke from testosterone products. The most popular product is AndroGel. Developed by Solvay Pharmaceuticals, AndroGel is a synthetic testosterone mixed into a gel. Then, it is applied the skin once daily. The skin absorbs the testosterone and aids those with low levels. The makers of AndroGel and other testosterone products are facing lawsuits filed by men who suffered strokes, heart attacks, and blood clots after use.
Manufacturers denied these sides effects for a long time. There are 27 studies available pertaining to the safety of testosterone drugs. Drug companies funded 13 of the studies and showed no heart attack risk. Fourteen independent studies showed the link. The National Cancer Institute discovered that within the first three months of beginning treatment, the risk of heart attack in men aged 65 or older doubled. Also, JAMA published a study reporting men under the age of 65 were at a threefold risk over men that did not use AndroGel.