Testosterone Therapy Attorney

About 5 million prescriptions are written each year for testosterone therapy. Many men who suffered from Low T and hypogonadism have been helped by hormone replacement products. However, the U.S. Food and Drug Administration has issued warnings to drug manufacturers, healthcare providers and patients that due to the results of recent studies, these medications could cause an increased risk of stroke, heart attack or death. Studies have also shown that men who already suffer with heart problems had an elevated risk when compared to those who did not. The manufacturer of one of the most popular brands used for replacement therapy recently issued a broader warning that their hormone replacement drug could cause serious medical problems for men who have heart, kidney or lung disease.

Testosterone is an essential hormone for the development of masculine characteristics. As a side effect of the natural aging process, hormone levels can change due to someone’s genetics, drug treatments such as chemotherapy, the onset of type 2 diabetes, or simply by a lack of production in the testicles. When the brain and the testes work in unison, the normal range for T levels is between 300 ng/dL and 1000 ng/dL. Since this hormone plays such an important role, changes in production can dramatically affect a man’s energy level, sexual desire, muscle mass, strength and fat distribution. Early studies funded by major pharmaceutical companies concluded there was no increased risks associated with using testosterone drugs.

At the Law Offices of Harrell & Harrell, our personal injury attorneys are tracking to see if unnecessary dangers were caused by the pharmaceutical companies’ aggressiveness in market positioning and new product campaigns. Some suggest their direct-to-consumer advertising may have been a contributing factor to possible misuse of replacement therapy drugs. Rumors have also surfaced that certain drug companies may have known through their own research that using their product was risky but did little or nothing to inform consumers. However, the FDA does recommend that anyone on a treatment plan should continue to take their medication as prescribed until they can discuss any concerns with their doctor.

Determining Who Has Liability for Damages

A study published in the Journal of the American Medical Association in November 2013 linked testosterone therapy products to serious side effects including heart attack, stroke and death. This has caused personal injury attorneys to begin investigating problems within the industry. From overly aggressive marketing strategies to a failure to provide adequate warnings for patients and healthcare providers, testosterone therapy litigation lawsuits will likely continue to rise with the accelerated use of the hormone replacement gels, injections, transdermal patches, buccal systems and sprays. The FDA has already warned medical providers about the risks associated with off-label use of products approved for treatment of hypogonadism. The manufacturers and licensed distributors of the following brand names may have liability for injuries documented in a testosterone lawsuit including:

Androderm®

FDA Testosterone Warnings & Safety Alerts: The U.S. Food and Drug Administration released a safety announcement on January 31, 2014 stating they are evaluating health risks associated with AndroDerm® and other testosterone therapy drugs. The risks include potential heart attack, risk of stroke, and death for men taking these FDA approved products.

What is AndroDerm?

Androderm® (testosterone transdermal system) is a topical prescription drug containing testosterone which is a naturally occurring male hormone essential for many processes in the body. There are two strengths of Androderm® available; one delivering 2 mg and the other delivering 4 mg of testosterone per day. The patch has a central drug delivery reservoir with a surrounding peripheral adhesive area. Androderm® is designed to provide testosterone to the body continuously over a 24 hour period. This drug is intended for adult males who have low or no testosterone as indicated by a blood test that was administered by a health care provider.

What are the side effects of AndroDerm?

Many of the Low T treatment drugs have been linked to serious side effects. Some of the serious side effects of AndroDerm® include but are not limited to:

• Nausea or Vomiting
• Swelling of the Ankles
• Difficulty Breathing
• Yellowing of the Skin or Eyes
• Red Blood in Stools
• Redness, Rash or Hives

NOTE: It is recommended that you tell your doctor about any side effects you may incur while taking this medication. These can also include frequent urination or difficulty urinating, changes in mood or swelling in the lower extremities.

AndroGel®

FDA Testosterone Warnings & Safety Alerts: On January 31, 2014, the Federal Drug Administration issued a FDA heart attack and stroke warning for AndroGel® stating that federal regulators are investigating the link between testosterone therapy drugs and certain medical conditions. New research suggests treatments may cause an increased risk of stroke, heart attack or even death.

What is AndroGel?

AndroGel® 1% or 1.62% is a hydroalcoholic gel that is available by prescription only to treat hypogonadism, a medical condition that may impact as many as 5 million men in the United States. Normally, the production of testosterone is controlled naturally in the brain by the hypothalamus and pituitary glands. Testosterone levels between 300 ng/dL and 1000 ng/dL are generally considered in the normal range for an adult male. When T-levels fall below the normal, brain signals are supposed to stimulate the manufacture of the hormone in the testicles. If not, low-T can affect changes in a man’s fat distribution, mood, energy levels and muscle mass.

Side Effects of AndroGel® Use

The most common side effects of AndroGel® include hypertension, mood swings, skin irritation at the application site, increase in red blood cells and an increased prostate-specific antigen count. Less common but more serious side effects may include:

• Breast Swelling or Tenderness
• Emotional Overreaction or Paranoia
• Frequent or Difficulty Urinating
• Swelling in Legs, Ankles or Feet
• Problems Breathing During Sleep
• Dizziness and/or Hot Flushes

NOTE: As with any medication, there could be other side effects in addition to those listed above. For example, if you already have an enlarged prostate gland, signs and symptoms can get worse.

Delatestryl®

FDA Testosterone Warnings & Safety Alerts: For men who are taking FDA approved testosterone products such as DELATESTRYL®; the U.S. Food and Drug Administration has issued a safety alert. They are currently investigating any connection between an elevated risk of heart attack, stroke, or death and men taking these products.

What is DELATESTRYL?

Delatestryl® is a prescription male sex hormone drug that works by substituting or augmenting the testosterone that is produced naturally in the human body. The generic name for this drug is testosterone enanthate, and is classified as an androgen. Your doctor will administer the testosterone drug via an injection into the gluteal muscle. Each milliliter of Delatestryl injectable solution contains 200 milligrams of testosterone in sesame oil and 5 milligrams of chlorobutanol that functions as preservative. The maximum dosage should not exceed more than 400 milligrams in a month. Your doctor will determine the overall dose and length of treatment based on your condition and response the the medication.

Side Effects of Delatestryl Use

The most common side effects of Delatestryl® include anxiety, headache, depressed mood, and pain or swelling at the injection site. You should seek emergency medical help you experience any signs of an allergic reaction. Call your doctor if you experience any of these less common but more serious side effects which may include:

• An increased or ongoing erection
• Rapid weight gain
• Confusion or memory problems
• Weakness or pain in the bones
• Stomach pain or loss of appetite
• Swelling or increased urination

NOTE: Given this is not a complete list of possible side effects, others may occur. Call your doctor if you have any unusual side effects and you may want to report them to the FDA as well.

Depo-Testosterone®

FDA Testosterone Warnings & Safety Alerts: For men who are taking FDA approved testosterone products such as Depo®-Testosterone; the U.S. Food and Drug Administration has issued a safety alert. They are currently investigating any connection between an elevated risk of heart attack, stroke, or death and men taking these products.

What is Depo-Testosterone?

Depo®-Testosterone Injection is an endogenous androgen prescribed by a medical physician to treat Low T in men. The generic version of this drug is testosterone cypionate, a white creamy odorless crystalline powder. Depo®-Testosterone Injection is available in two different strengths, 100 mg/mL and 200 mg/mL. Each milliliter of the 100 mg/mL solution contains 100 mg of testosterone cypionate, 0.1 mL of Benzyl benzoate, 736 mg of cottonseed oil, and 9.4 mg of Benzyl alcohol. Each milliliter of Depo®-Testosterone 200 mg/mL solution contains 200 mg of Testosterone cypionate, 0.2 mL of Benzyl benzoate, 560 mg of cottonseed oil, and 9.4 mg of Benzyl alcohol which acts as a preservative in both available strengths.

Side Effects of Depo-Testosterone Use

The most common side effects of Depo®-Testosterone include headache, mood changes, anxiety, and pain or swelling at the injection site. You should seek emergency medical help if you experience any signs of an allergic reaction such as difficulty breathing, hives, rash, or swollen throat. Call your doctor if you experience any of these less common but more serious side effects which may include:

• High blood pressure
• Enlarged or sore breasts
• Problems with Urination
• Abdominal pain
• Yellow eyes or skin
• Pale stools

NOTE: It’s very possible that you or others may experience side effects other than the ones listed above. If you notice any sign or symptom that worries you while taking Depo®-Testosterone, do not hesitate to call and check with your doctor.

Testopel®

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.

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.

Here are some other common testosterone therapy drugs that have documented lawsuits:

• Axiron: Developed by Acrux, an Australian pharmaceutical company, and approved in 2010, the product is marketed in the United States by Eli Lilly & Company. The topical solution is applied to the armpits with a reusable cup applicator. Special care should be taken in cleaning, storing and disposing of the product to avoid accidental exposure in women, children and pets.
• Bio-T-Gel: Approved in February 2012, this once daily transdermal gel was developed by BioSante Pharmaceuticals and later licensed to Teva Pharmaceuticals. 50 mg of endogenous androgen is applied to dry skin on the shoulders or upper arms for 24-hour delivery from a single application. By comparison, the product is not heavily used.
• Foresta: Manufactured by Endo Pharmaceuticals, this spray gel was approved by the FDA in December 2010. The product is applied to the front and inner thighs once a day. The product does warn that the gel spray is not intended for use in women or males under the age of 18 years.
• Striant: The developing pharmaceutical company, Actient Holdings LLC., was purchased by Auxilium Pharmaceuticals in April 2013 who currently markets the sustained-released buccal system. Small patches containing the hormone are placed between the cheek and gum just above the incisor tooth – one in the morning and one in evening following routine dental care.
• Testim: Testim 1% is one of the most widely used products to treat hypogonadism and Low T levels in men. The U.S. Food and Drug Administration issued a black box warning to Auxilium Pharmaceuticals in 2009 requiring the manufacturer to include explicit warnings about risk factors associated with replacement therapy drugs.

With a five-fold increase in the number of prescriptions written each year, big pharmaceutical companies are positioned to make billions off this niche healthcare market. Prior to the release of several recent studies, many doctors were unaware of many of the risks involved. Today, the entire medical community has been warned about the risks associated with various treatment plans as well as those groups of men who are at increased risk because of heart conditions, prostate cancer and liver problems.

Conversation with Your Healthcare Provider

If you have symptoms of Low T, the most important first step is to make an appointment with your doctor to discuss your specific medical condition. The changes that you may have been experiencing could be natural signs of aging and only a healthcare provider can order the blood tests that accurately measure your testosterone levels. This is the fastest way to rule out related conditions such as signs of aging and diagnose hypogonadism as the actual cause of your problems. You will also be able to discuss what treatment options are available to manage your condition. Don’t be surprised if diet, exercise and a change of lifestyle are prescribed along with options for medical therapies for hormone replacement.

Maintaining T levels in the right range can be very important to how a man feels, retaining muscle strength and controlling the distribution of body fat as well as his sex drive and sexual performance. However, there has been an alarming number of cases involving testosterone therapy litigation where the injured party did not suffer from hypogonadism and medication was prescribed in hope of reversing some signs of premature aging. The U.S. Federal Drug Administration has issued FDA warnings to manufacturers, distributors and the medical community that these drugs have not been approved for off-label applications. If you or a loved one suffered with heart attack, stroke, prostate cancer, kidney or liver damage while taking hormone replacement products, contact the Law Offices of Harrell & Harrell at 904-251-1111 or 1-800-251-1111 for a free consultation to review your case.