What Is AndroGel?
Truth: AndroGel is designed for use by men with low testosterone levels due to a medical condition.
Truth: Some men using AndroGel have experienced heart attacks, strokes, and blood clots as a result.
Truth: Many patients have sued AbbVie, the manufacturer of AndroGel, because they were not adequately warned of the risks.
AndroGel is a testosterone replacement therapy meant to restore testosterone levels in men whose testosterone is lower than normal due to medical conditions. Around 4,200 men who used AndroGel have experienced severe side effects, including heart attacks. If you have experienced such severe side effects as the result of using AndroGel, contact us now.
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AndroGel is a testosterone hormone replacement that’s used to bring low testosterone levels to a normal rate. It is applied topically as a gel once a day. The testosterone is then absorbed into the skin. It’s designed to be used only for treating medical conditions, not for the loss of testosterone due to aging. AndroGel should also not be used by women, especially not those who are pregnant or nursing because it could harm the fetus or baby.
Who Makes AndroGel?
AndroGel is produced by a company called AbbVie. It was developed and submitted to the FDA for approval as a testosterone replacement therapy gel.
What Is AndroGel Used For?
The FDA approved the use of AndroGel to treat hypogonadism, which is a low production of sex hormones, which is testosterone in men. It’s treated with prescription hormone replacement therapy. AndroGel was approved by the FDA for use in males with testosterone deficiency.
How Does AndroGel Work?
AndroGel should be applied daily to clean, dry skin in the shoulder and upper arm area. The gel is then absorbed through the skin, where it enters the bloodstream and helps to restore testosterone to normal levels. A testosterone replacement such as AndroGel is supposed to maintain or develop the usual characteristics of masculinity, as well as provide other benefits, including:
- Maintain a deep voice
- Maintain body hair
- Prevent bone loss
- Maintain muscle mass
All of these characteristics are natural for sexual ability and desire in men, so AndroGel should not be used by women.
The dosage and instructions can vary depending on the person, so it is important to follow the doctor’s instructions. Men should also make sure to avoid allowing anyone else to come into contact with the gel, which would not be prescribed for them, and so should wash the area where the gel was applied carefully if physical contact is expected.
What Are the Risks of Using AndroGel?
Accidental Exposure of Others
Because AndroGel is a topically applied medication, the FDA cites there is a risk of others who have not been prescribed the medication coming into contact with it. This is especially dangerous for children and for women, especially those who are either pregnant or nursing, as the fetus or baby could be harmed. The signs of accidental exposure include:
- Body hair changes
- Acne increases
- Early pubic hair development
- Enlarged genitals
- Increased sex drive
- Aggressive behavior
Side Effects of AndroGel
If someone else is suspected to have come into contact with the gel who was not prescribed it, they should immediately seek medical advice.
The side effects of AndroGel can include:
- Hair loss
- Increased hair growth
- Difficulty sleeping
- Changes in skin color
- Swelling or tenderness of the breasts
- Redness, itching, burning, hardening, or swelling of the skin
Severe Side Effects
The more severe side effects can include the following:
- Weight gain
- Swelling in the ankles or feet
- Breast enlargement
- Difficulty breathing
- Difficulty or increased urination (especially at night)
- Yellowing of the eyes
- Pain while urinating
- Yellow urine
- Testicle pain or enlargement
A doctor or pharmacist should be consulted if any of the more severe side effects are experienced, or if any of the more minor side effects persist over a period of time or grow worse.
Risk of Heart Attack or Stroke
Even more severe side effects can result from the misuse of AndroGel and include the following:
- Heart disease
- Heart attack
- Liver disease
- Blood clots
- Mood or mental problems
- Unusual drug-seeking behavior
- Improper bone growth in adolescents
Some of the most severe side effects require immediate medical attention. They could be signs of a heart attack or stroke. These include:
- Shortness of breath and rapid breathing
- Pain in the jaw, chest, or upper arm
- Fainting or dizziness
- Unusual sweating
- Pain or swelling in the groin or calf area
- Sudden vision changes
- Severe headaches
- Difficulty speaking
- Weakness on one side of the body
Increased Risks with Pre-Existing Conditions
There are increased risks of severe side effects with any of the following pre-existing conditions:
- Breast cancer
- Prostate cancer
- Heart problems
- Urinary problems from an enlarged prostate
- Liver or kidney problems
- Sleep apnea or other sleep disorder
Any other pre-existing medical condition should also be reported to doctors because of the risk of AndroGel interacting with other medications or conditions.
FDA Alerts and Investigations
The FDA approved AndroGel and other testosterone replacement therapies only for men who had medical conditions causing a lower-than-normal testosterone level. This approval came with a black box warning label about the risks of secondary exposure, or other people, especially children, not prescribed the gel coming into contact with it secondhand.
In 2014, following reports of heart attacks and other cardiac events as the result of taking AndroGel and other testosterone replacement therapies, the FDA issued an alert of their investigation. This investigation looked into the risks of heart attacks, strokes, and even death. The alert urged doctors and patients to take the risks of possible cardiac events into consideration before getting a prescription.
In 2015, the FDA alert was updated to include a required label change to the black box warning that was already present on AndroGel and other testosterone replacement therapies. This change included the risk of strokes and heart attacks that were associated with the use of such testosterone replacements.
Litigation Against AbbVie
As of 2018, there were nearly 7,000 lawsuits filed around the United States, filed by men who claimed that testosterone replacements had caused heart attacks, blood clots, and strokes. 4,200 of those lawsuits were against AbbVie for their AndroGel testosterone replacement therapy. By September of 2018, all of the companies besides AbbVie had already settled the cases outside of court.
The lawsuits claimed that AbbVie and the other companies failed to properly warn men of the risks of heart attack and other severe side effects that could come from using AndroGel and other testosterone replacement therapies.
Jesse Mitchell Case
Jesse Mitchell sued AbbVie in Chicago when he experienced a heart attack following his use of AndroGel. A jury awarded him $150 million dollars, but the case was later overturned out by a judge in Chicago in January of 2018. The judge claimed that the verdict was inconsistent and recommended a new trial.
The new trial ruled that while AbbVie may not have falsely marketed AndroGel, it did find that the company had been negligent and thus awarded Jesse Mitchell a favorable verdict, including monetary awards of $200,000 in compensation and $3 million for punitive damages.
As of March 2018, AbbVie had also been ordered to pay $140 million to a man from Tennessee who also had a heart attack that he claimed was caused by his use of AndroGel. AbbVie has announced that it intends to appeal both this case and Jesse Mitchell’s case. A case filed in Arizona saw the company held not liable for the plaintiff’s heart attack. However, there are still more than 4,000 cases against AbbVie that are pending and of the testosterone replacement therapy manufacturers, AbbVie is the only one that has not settled out of court.
Have You Suffered Complications from AndroGel?
If you have been using AndroGel and have experienced any severe symptoms or complications, including a heart attack, stroke, blood clots, or another cardiac event, the first step is to contact a medical professional. The doctor can help you determine if your heart attack or other medical condition could have been caused by the use of AndroGel.
Should You Consider an AndroGel Lawsuit?
If you believe that your heart attack, stroke, or other medical condition was caused by the use of AndroGel, schedule a free consultation with a Farah and Farah attorney today. Make sure you get the justice you deserve with one of our highly experienced lawyers who can guide you through the process. There is no cost to you unless your case has a successful outcome.
Co-counsel will be associated on these cases.