Fortesta® Testosterone Attorneys

FDA Testosterone Warnings & Safety Alerts: A safety alert was issued in September of 2013 by the U.S. Food and Drug Administration stating that early signs and symptoms of puberty in young children have occurred due to accidental exposure to the testosterone drugs. The FDA has approved a safety labeling change to the drug containers informing the public of the potential associated risks.


FORTESTA® is a brand of testosterone Replacement therapy prescription medication that contains testosterone and used by men who have low or no testosterone. FORTESTA® is a clear, colorless, and odorless gel that is applied to the front and inner thighs. This drug is used to treat males who suffer from a deficiency or absence of testosterone production known as hypogonadism and hypogonadotropic hypogonadism. This topical gel comes in a 2 percent concentration of testosterone and is generally applied once a day. Just two pumps on the small canister contains about 20 mg of the testosterone gel.

Important Safety Information

FORTESTA® Gel is considered a controlled substance (CIII) due to the fact that it contains testosterone and potentially targeted by people who abuse prescription meds. This topical gel can transfer from you to others if they come in contact with the area where the gel was applied. The drug distributor Endo Pharmaceuticals recommends that you wash your hands thoroughly after applying the gel to reduce the risk of transfer to others.

Women and children should be extra cautious not to come into contact with unwashed clothes or exposed areas of skin where FORTESTA® was applied. If women or children do happen to contact an area where the gel was applied, they should wash the area with soap and water immediately. You should stop using FORTESTA® and contact your doctor right away if you see any signs or symptoms in women or children due to potential accidental exposure to FORTESTA.®

What are some of the side effects associated with FORTESTA?

Studies have revealed health risks associated with the use of low testosterone treatment methods. The FDA has recently issued a safety announcement stating that they are investigating the risk of heart attack, stroke, and death in men taking FORTESTA® and other testosterone products. It is recommend that you stop using testosterone and alert your doctor if you experience any of the following side effects:

  • Blistering of skin where gel is applied
  • Urination problems
  • Prolonged, frequent, or troublesome erections
  • Stomach pain or nausea
  • Low fever or loss of appetite
  • Dark urine or clay-colored stools

NOTE: It is still unknown whether taking FORTESTA® Gel and other related testosterone products can increase the risk of high blood pressure, heart attack, stroke, and other heart related issues.

What are some of the signs or symptoms of early puberty in children who were accidentally exposed to testosterone?

Signs and symptoms of early puberty in children include enlarged genitals in both boys and girls. You may also see early development of pubic hair and unusual aggressive behavior. You should stop using FORTESTA® and call your doctor if you notice any of the above signs or symptoms in children.

How is the male hormone testosterone produced in the body?

The male testes are responsible for most of the production of testosterone in his body. Nevertheless, it is the pituitary gland that controls the cycle by which the male’s gonads produce testosterone. So if this process slows down in any way the result is Low T in men.

What are some of the potential causes of Low Testosterone?

Low Testosterone can occur as the result of an injury, medical condition, or naturally at child birth. If the testicles are the cause of the problem, then primary hypogonadism is the general term the condition for which the condition is often referred to. A problem in the hypothalamus and pituitary brain structures can result in another form of Low T as well.

Testosterone Therapy Lawsuits

The pharmaceutical attorneys at Harrell & Harrell are currently investigating claims related to low testosterone therapy meds. Research continues to show that low testosterone therapy drugs prescribed to men can increase the risk of heart attack, stroke, and death. We believe these risks were not properly revealed by the pharmaceutical company which led to many men taking a drug they may have otherwise not taken had they know the true risks. It must be noted that FORTESTA® is only approved by the FDA to treat particular medical conditions.

Our experienced testosterone therapy drug lawsuit attorneys are here to help you get the just compensation you deserve. It’s our job to hold these companies accountable for their negligent testing and over marketing of a product with so many health risks. If you or a loved one has suffered injury after taking FORTESTA® Gel or you happen to be the surviving family member of someone who tragically passed as the result of taking FORTESTA®, a wrongful death lawsuit can still be filed. So contact one of our attorneys at Harrell & Harrell at 904-251-1111 or 1-800-251-1111 for a free consultation.

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