Androgel is a prescription testosterone supplement manufactured by Abbott Laboratories. It is intended for men with hypogonadism, which is caused by significantly lower than average levels of the hormone testosterone.
According to Androgel’s official website:
“AndroGel (testosterone gel) 1% and 1.62% are controlled substances, available by prescription, used to treat adult males who have low or no testosterone due to certain medical conditions. It is not known if AndroGel is safe or effective to treat men who have low testosterone due to aging. It is not known if AndroGel is safe or effective in children younger than 18 years old. Testosterone products that are applied to the skin may have different doses, strengths, or application instructions that may lead to different levels of testosterone in your body.”
Though viewed as safe by many in the healthcare industry, Abbott faces numerous lawsuits regarding Androgel, after users claim they suffered various cardiovascular complications while using the medication. Problems include elevated heart attack and stroke risk, as well as blood clots, hypertension, sleep apnea, reduced sperm counts, and enlarged breasts.
Despite being approved only for men with diagnosed hypogonadism, Androgel is often prescribed to men with all levels of reduced testosterone, even without any official diagnosis of a disease or with a diagnosis of only “low-T.”
Side Effects of Androgel
Androgel labels include the following warnings related to allergic reactions and other complications users might experience:
- Difficulty breathing
- Swelling of the face or mouth
- Increased, or painful or difficult urination
- Loss of bladder control
- Breast pain or swelling
- Painful or bothersome erections
- Rapid weight gain
- Shortness of breath during sleep
- Symptoms that could indicate a problem with the liver, such as nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, or jaundice
- Signs of a blood clot in the lung, including chest pain, sudden cough, wheezing, rapid breathing, coughing up blood
- Signs of a blood clot in the leg, including pain, swelling, warmth, or redness in one or both legs
Despite mention of blood clotting, there is little attention paid to serious cardiovascular problems in Androgel’s list of potential side effects.
FDA Warning about Androgel
The US FDA launched an investigation into Androgel in January 2014 after two separate medical studies showed users suffering a significant increase in heart attack risk.
In the first study, men under 65 years of age using Androgel showed a twofold increased risk when they had a pre-existing heart health issue, and men over 65 showed a twofold increase in heart attack risk regardless of their heart health. The second study showed a nearly 26% increase in stroke or heart attack risk for men on testosterone therapy.
Following review of the studies, the FDA issued caution to medical professionals, urging them to be aware of the risks and exercise extreme caution when prescribing Androgel.
Androgel Legal Action
Men negatively affected by Androgel use are taking legal action against Abbott Laboratories. Shortly after the FDA safety announcement was issued, five men filed lawsuits related to their heart attacks and strokes they believe were caused by Androgel.
Legal experts predict the number of lawsuits will continue to grow as more and more men realize their health problems could be connected to Androgel. Many believe Abbot was aware of the risks associated with its product, but failed to warn of any serious side effects.
Furthermore, the product has been the subject of an aggressive direct-to-consumer marketing campaign. Despite very few men having hypogonadism, testosterone therapy is one of the most commonly prescribed drugs available. Many believe without the aggressive marketing campaign, men would be reluctant to take the medication without an official diagnosis of hypogonadism.
There are several lawsuits currently pending in courts throughout the country and the Executive Committee of the US District Court is in the process of consolidating these cases in the Northern District of Illinois. Once consolidation occurs, all cases filed in US District Courts will be centralized in Illinois, speeding the process and preventing any inefficiency of duplicate discovery.
Accusations in the suits range from blood clots to heart attack and stroke to death. Plaintiffs also claim Androgel makers failed to warn users of the potential risks. Men who used testosterone continue to draw the connection between the product and their medical problems.
In addition to the Androgel lawsuits, many other testosterone supplement companies are facing legal action.