Striant® Testosterone Attorneys FDA Drug Approval & Therapeutic Evaluations: Actient Pharmaceuticals received approval from the U.S. Food and Drug Administration in June 2003 for Striant®, a buccal testosterone system prescribed for the treatment of male hypogonadism. What is Striant? Striant® is a sustained-release 30 mg. buccal testosterone system designed to adhere to the gum or inner cheek. Insertion of one system twice a day, once in the morning and again in the evening, provides continuous delivery of the endogenous androgen for the daily treatment of male hypogonadism. A single system is placed in a comfortable position above an incisor tooth. Either side of the mouth can be used but it is advisable to rotate the morning and afternoon treatment sites. Striant® is designed to stay in position until removed. The system should be removed before you brush your teeth or perform other routine oral care and followed by the application of a new system. Important Safety Information Actient Holdings LLC., the developing pharmaceutical company, was purchased by Auxilium Pharmaceuticals, Inc. in April 2013. Auxilium also markets Testim® 1% testosterone gel for the topical treatment of hypogonadism. Striant® is a Schedule III controlled substance due to the potential for abuse. Like other hormone replacement products, it is contraindicated in women who are or may become pregnant, or who are breastfeeding as the drug may cause fetal harm or serious adverse reactions in nursing infants. At this time, adequate studies of the use in pediatric patients under the age of 18 have yet to be conducted. As a buccal system for extended delivery, Striant® is applied between the cheek and gum just above the incisor tooth on either side of the mouth. While available test results support the safe use of this process of testosterone therapy, regular gum inspections are recommended and any irregularities should be brought to the attention of the patient’s healthcare provider. The majority of adverse events subside with 1 to 2 weeks without having to alter treatment plans. A bitter taste, gum tenderness and edema are common complaints that seldom require discontinuance. Application areas should be checked following the consumption of food or beverages to ensure the buccal system is still in place. Side Effects of Striant Use Yellow Jaundice (skin or eyes) Problems Urinating or Dark Urine Breathing Problems while Sleeping (Apnea) Emotional Changes (like depression) Enlarged or Tender Breasts Extra Fluid in the Body (Edema) NOTE: Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma. Older patients should be tested for presence of prostate cancer prior to beginning treatment. How do I use the buccal system? After your morning dental care, one buccal system is applied to the upper gum above the incisor tooth on either side of the mouth and is left in place for approximately 12 hours. The same procedure is repeated after dental care in the evening and the buccal system will be replaced the next morning. If a system is removed prior to the full release of medication, a new system is inserted and then removed on schedule. Does Striant require special storage? Yes. The blister package should be protected from moisture and heat (68? to 77?). As is the case with all medications, Striant® should be kept out of the reach of children. How does the medication get into my body? The buccal system allows for a slow release of testosterone (approximately 12 hours) as the medicine is absorbed through the gum and cheek surfaces. The trans-buccal approach allows for delivery that circumvents first-pass metabolism in the liver. What should I do to dispose of a used buccal system? When you remove a used buccal system, it can be discarded in normal household trash. However, extreme caution should be taken to prevent children or pets from accidental exposure to the testosterone product. If unwanted contact is made, all areas exposed to the used system should be washed immediately. Testosterone Therapy Lawsuits Although the exact impact of testosterone therapy products and treatment plans are not completely known, the attorneys at Harrell & Harrell are keeping close watch on current litigations, verdicts and settlements. The FDA has already ruled in favor of black box warnings on some labeling as well as issuing mandates to doctors and other healthcare providers as to the medical problems for which hormone therapy drugs are approved for treatment. In addition, the symptoms of Low T levels often are difficult to distinguish from signs of aging and/or other health conditions. Since none of the FDA-approved testosterone therapy products are cleared for use in men who have not been accurately diagnosed with specific forms of hypogonadism, off-label usage is subject to legal scrutiny. If you or a loved one were prescribed Striant® and suffered serious medical conditions like a heart attack, stroke, liver damage or even death, you or family members may be entitled to file a lawsuit for retribution. Contact the Law Offices of Harrell & Harrell at 904-251-1111 or 1-800-251-1111; or use this website’s Do I Have A Case form for a prompt response to your inquiry.