FDA Testosterone Warnings & Safety Alerts: On March 24, of 2010, the Federal Drug Administration along with the Division of Drug Marketing, Advertising, and Communications issued a warning letter to Slate Pharmaceuticals. The DDMAC concluded that sales aids, web pages, and videos on the site were misleading and promote unapproved uses of Testopel®. It was found that the promotional materials misbranded the drug and were in violation of the Federal Food, Drug, and Cosmetic Act and FDA implementing regulations.

What is Testopel?

Testopel® is an FDA approved testosterone replacement therapy prescription for men with conditions associated with low testosterone in the body. This drug is in the form of a pellet that contains 75 mg of crystalline testosterone. Other ingredients in Testopel® pellets include .97 mg of stearic acid, and 2 mg of polyvinylpyrrolidone. These cylindrically shaped pellets are roughly 1/8 of an inch in diameter and 9 mm long. They are implanted under the skin where they slowly deliver testosterone to the body overtime. Like other androgens, Testopel® are steroids that develop and maintain male sex characteristics.

Important Safety Information

Any men who have carcinomas of the breast or prostate should not use Testopel® as well as other androgens. Men should avoid any prolonged use of high doses of this medication as it has been associated with life threatening and fatal complications including peliosis hepatitis and hepatic neoplasms. It is unknown whether men treated with androgens are at an increased risk for prostatic hypertrophy and prostatic cancer. It’s common for patients being treated for hypogonadism to develop gynecomastia.

Testopel® and other androgens has not been shown to be safe and effective when used solely to enhance athletic performance. They are indicated for testosterone replacement therapy for medical conditions related to an absence or lack of endogenous testosterone in the male body. Such medical conditions include congenital or acquired primary hypogonadism causing testicular failure due to bilateral torsion, cryptorchidism, vanishing testes syndrome, orchiectomy, or orchitis.

Side Effects of Testopel Use

The most common side effects of Testopel® include gum or mouth irritation, hypertension, mood swings, and skin irritation at the application site. You should seek emergency medical help if any of the following symptoms occur while taking Testopel®:

  • Sudden and severe inability to speak
  • Sudden and severe weakness in arm or legs
  • Slurred speech
  • Seizures
  • Blurred vision
  • Temporary blindness

NOTE: The above listed symptoms could indicate a potential overdose of the prescribed medication. Some side effects of Testopel® pellets may not be yet reported and you should always consult your doctor or physician for medical advice.

Testosterone Therapy Lawsuits

Our attorneys here at Harrell & Harrell are accepting claims from men who have suffered from medical complications while taking testosterone therapy medications such as Testopel. Many men across the country are being influenced by aggressive marketing tactics to seek treatment for low energy, decreased libido, mood changes and more. Testosterone products are FDA approved only for men who have associated medical conditions. Yet prescriptions for Low T therapy have doubled since 2006. Recent studies have found that nearly 25 percent of the patients never even had their testosterone levels checked before receiving a prescription.

Our exceptional team of attorneys are here to help you fight the pharmaceutical manufacturers who failed to properly warn the public about the associated risks of taking testosterone products. If you or a loved one suffered heart attack, stroke, or serious health problems while on Low T therapy, you may be entitled to compensation. Our attorneys here at Harrell & Harrell will work tirelessly to ensure the major drug companies are held accountable for their negligence. For a free consultation, contact our office at 904-251-1111 or 1-800-251-1111.

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