Testim® Testosterone Attorneys
FDA Black Box Warnings & Safety Labeling: In 2009, the U.S. Food and Drug Administration announced that it was requiring the manufacturer of Testim®, Auxilium Pharmaceuticals, to include a boxed warning on the label of its topical testosterone gel product. The FDA’s sternest warning came after the agency reviewed reports of adverse effects in children who had secondary exposure to the hormone after contact with a person being treated with Testim®.
What is Testim?
Testim® 1% is a prescription testosterone gel approved by the FDA for use in men who either no longer produce the hormone or produce it in very low amounts. Testosterone and DHT are endogenous androgens that are responsible for normal growth and development of the male sex organs as well as for maintenance of secondary sex characteristics larynx enlargement, maturation of the prostate gland, facial hair and body musculature. Unlike other topical solutions, this product provides continuous transdermal delivery of hormone replacement for 24 hours following a single application. The gel should be applied to clean, dry skin, unbroken skin on the shoulders or upper arms only.
Important Safety Information
The U.S. Food and Drug Administration originally required a black box warning after receiving several reports that children had experienced adverse events after coming in contact with the medication. Signs and symptoms have included enlargement of genitalia, development of pubic hair, increased libido, aggressive behavior and advanced bone age. In most cases involving children, unexpected signs and symptoms regressed once their exposure to the testosterone product was removed. However, based on the child’s chronological age, in some cases bone age or sexual organs remained greater than normal.
According to a study published in the Journal of the American Medical Association, men with heart conditions were more likely to suffer a stroke, heart attack or testosterone death when compared to those who did not participate in hormone replacement therapy. Men treated with androgens may also be at an increased risk for developing prostate cancer, blood clots in the legs and liver damage. If you were prescribed Testim® and have suffered a serious medical condition, then you should seek legal counsel to review the details of your case.
Side Effects of Testim Use
For many men, treating the sexual symptoms associated with Low T would be enough reason to seek treatment. However, testosterone therapy doesn’t come without risks and may result in mild to serious side effects including:
- Skin Blistering at Patch Site
- Problems with Urination
- Nausea and Stomach Pains
- Prolonged or Painful Erections
- Problems Breathing During Sleep
- Dark Urine or Clay-Colored Stools
NOTE: The accumulation of extra fluid (edema) may be a serious complication in some patients who have preexisting cardiac, renal or hepatic disease.
What is a boxed warning?
In the United States, a boxed warning (sometimes called a black box warning) is a type of alert named for the black border surrounding the text of the warning that appears on the package insert, label, and other literature for a specific medication. It is the sternest warning required by the Food and Drug Administration to alert you and your healthcare provider about important safety concerns.
Why would the FDA require a black box warning?
The FDA required the boxed warning for Testim® to provide a concise summary of the undesirable side effects and health risks associated with secondary exposure to the medication. Although the medication is safe for use in adult males, it can produce adverse and sometimes very serious reactions in both women and children meaning extra caution is required.
What is the indicated usage for Testim?
Testosterone therapy is indicated for hormone replacement therapy in adult men who suffer from conditions associated with a deficiency or absence of endogenous testosterone.
Who should be excluded from using this product?
Testim® is contraindicated in men with breast cancer or prostate cancer (whether known or suspected). It is not intended for use in women or children under 18 years of age. In pregnant women, it may cause fetal harm and serious adverse reactions to nursing infants.
Testosterone Therapy Lawsuits
Our attorneys are closely following the increase in claims related to the serious side effects experienced in men who were prescribed treatment using Testim®. In some cases, doctors simply ignored FDA warnings and prescribed testosterone treatment off-label to help men fight a natural decline in energy levels or to improve sex drive and strengthen bone density. With sales in the billions, aggressive direct-to-consumer advertising campaigns may have targeted men who may not suffer from the specific medical conditions for which the hormone replacement therapy was approved.
The FDA approved the drug only as a testosterone replacement therapy for use in men who either no longer produce the male sex hormone or produce it in very low amounts (primary hypogonadism and hypogonadotropic hypogonadism). If you or a loved one were prescribed Testim® and suffered a serious medical condition or death, you may be entitled to compensation for your damages. Contact our personal injury attorneys at 904-251-1111 or 1-800-251-1111; or use this website’s Do I Have A Case form for a prompt response.