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Schachter, Hendy & Johnson, Attorneys At Law

Does the FDA Think AndroGel is Safe?

On January 31, 2014, the United States Food & Drug Administration (FDA) announced that it was investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products, including AndroGel.

The FDA state it had "decided to reassess this safety issue" based on two separate studies finding an increased risk of cardiovascular events among men prescribed testosterone. The FDA has not yet announced its final conclusions and recommendations. This type of announcement can signal a potential labeling change or other government action.

On June 19, 2014, the FDA issued a partial labeling change for testosterone warning that testosterone can cause blood clots in the lung and legs.

On July 15, 2014, the Canadian counterpart to the FDA, Canada Health announced a labeling change for testosterone. As a result of their investigations, Canada Health found that testosteorne medications posed risks of heart attacks, strokes, blood clots and increased or irregular heart beats.

On September 17, 2014, the FDA met to further weigh the risks of testosterone. The FDA is strongly considering restricting the prescription and use of testosterone in light of the serious risks of the drug. This rule change would limit the number of men taking testosterone and insurance coverage for the drugs.

If you or a loved one had a heart attack, stroke, pulmonary embolism or blood clot while taking testosterone, please call our experienced testosterone attorneys at (888) 606-5297 for a free consultation about your potential testosterone lawsuit.

Sarah N. Emery
Associate Attorney at Schachter Hendy & Johnson PSC

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