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AndroGel

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AndroGel is the blockbuster gel used to treat low testosterone (“Low T”), but it is linked to an increased risk of cardiovascular problems. Many men filed lawsuits against Abbott and AbbVie.

One of the most-used medical products to treat Low T is AndroGel. Made and heavily marketed in the United States by AbbVie Inc., AndroGel is prescribed as a testosterone-replacement drug, mostly to men whose bodies fail to produce sufficient amounts of the male hormone.

The drug was developed by Brussells-based pharmaceutical company Solvay Pharmaceuticals, and the U.S. Food and Drug Administration (FDA) approved it in 2011 for use by men diagnosed with Low T.

Abbott Laboratories, AbbVie’s parent company, bought the drug from Solvay in 2010 and soon began pumping millions into the drug’s marketing. Within two years, doctors sounded alerts about the drug’s dangerous side effects for older users after many men gained prescriptions as a way to regain their youth or simply boost energy and sex drive.

One of the biggest risks with AndroGel and other testosterone products is an increase in cardiovascular events like heart attacks and strokes. The makers of AndroGel now face a growing number of lawsuits filed by men who suffered strokes, heart attacks and blood clots after using the drug. The lawsuits state Abbott and AbbVie failed to warn consumers about these risks.

According to a study published in JAMA, by 2011 nearly one in 25 men in their 60s took testosterone. Doctors blame the rampant advertising.

“The market for testosterone gels evolved because there is an appetite among men and because there is advertising. The problem is that no one has proved that it works, and we don’t know the risks,” Dr. Joel Finkelstein, an associate professor at Harvard Medical School, told The New York Times.

AbbVie spent $80 million on aggressive marketing campaigns in 2012, and the gel generated over $1 billion in sales that year. AndroGel is the top-selling testosterone product in the U.S. AbbVie markets it in the U.S., while Abbott markets it overseas.

What is AndroGel and How Does it Work?

AndroGel is synthetic testosterone mixed into a gel with alcohol that is applied to the skin once daily. The testosterone is absorbed into the skin for continuous 24-hour delivery into the body. The medication can cost as much as $500 a month, but some insurance companies will cover it.

The drug is available in two strengths: 1 percent and 1.62 percent. Patients dispense the gel through a multi-dose pump or use single-dose packets. It is quick-drying, clear and odorless when dry.

The two dose strengths have different application sites. Patients can apply the 1 percent gel to the upper arms and shoulders, as well as on both sides of the abdomen. For the 1.62 gel, the gel should only be applied to the upper arms and shoulders.

In men with Low T, the medication increases the total amount of circulating testosterone in the body to a normal range found in healthy men ­– according to the drug insert, this measurement is somewhere between 298 – 1043 ng/dl. If men use lotion or sunscreen, the amount of testosterone absorbed increases.

After applying AndroGel, men should wash their hands thoroughly with soap and water. It is also important to know that the drug is flammable until dry, and patients should avoid flames, smoking or fire.

Black-Box Warning for Secondary Exposure

AndroGel has a black-box warning for secondary exposure to women and children, and patients should take precautions and follow application instructions carefully to avoid accidental exposure.

Women and children should avoid contact with unwashed application sites or unwashed clothing of men using the drug. Men using the medication must cover all application sites with clothing. Patients should wash any application sites before any skin-to-skin contact.

Women and children may show symptoms of secondary exposure, including:

  • Enlargement of the genitals
  • Early development of pubic hair in children
  • Increased erections
  • Increased libido
  • Aggressive behavior
  • Advanced bone age in children
  • Increase in acne and body hair in women

Contact a doctor if symptoms of secondary exposure develop, and discontinue use of the gel until advised by the doctor.

Heart Attacks and Other Side Effects

One of the most dangerous side effects of AndroGel is its link to cardiovascular problems like heart attacks and strokes. Recently, a number of studies revealed that men using testosterone drugs are at increased risk of heart attack and stroke.

For some doctors, like Sidney Wolfe of the watchdog group Public Citizen, the evidence is enough to merit a black-box warning on AndroGel and other drugs like it. The nonprofit group petitioned the FDA to require warnings for cardiovascular risks on the drugs’ packaging.

Wolfe told Drugwatch that there are about 27 studies available on the safety of testosterone drugs; 13 of these are funded by drug companies and show no heart risk, while 14 independent studies revealed a risk.

In addition to serious cardiovascular risks, AndroGel may also cause a number of other side effects, including:

  • Prostate Cancer. Patients treated with androgen (hormone) therapy are at increased risk for enlargement of the prostate as well as developing prostate cancer.
  • Larger Red Blood Cells. The gel may cause red blood cells to grow. Because the cells can become too large, patients who take this medication are at increased risk for blood clots, which can lead to stroke.
  • Reduced Sperm Count. When the hormones in a man’s body increase, it affects sperm production. In some cases, this is irreversible.
  • Edema. The gel is known to cause water and sodium retention. In men with pre-existing liver, kidney or heart disease, this can cause swelling and congestive heart failure.
  • Gynecomastia. Men using this drug may develop enlarged breasts.
  • Sleep Apnea. Using AndroGel may worsen or cause men to develop sleep apnea.
  • High cholesterol. The drug increases the levels of cholesterol in the body, and doctors may recommend discontinuing treatment.

Lawsuits

In February 2014, five men sued Abbott Laboratories and its spinoff, AbbVie, Inc., alleging injuries caused by AndroGel. The plaintiffs’ ages range from 50 to 63. Three of the men suffered heart attacks, and two suffered strokes. The lawsuit was filed in the U.S. District Court for the Northern District of Illinois.

The plaintiffs include 54-year-old Michael Gallagher of Virginia, who suffered myocardial infarction, congestive heart failure and other injuries after being prescribed the gel. He had no history of cardiac problems before taking the prescription drug, Mr. Gallagher claims he started AndroGel therapy after the defendants’ advertisements led him to attribute symptoms to low testosterone.

According to the complaints, Abbott and AbbVie “deceived potential users by relaying positive information through the press, including testimonials from retired professional athletes” and statistics suggesting a widespread need for the drugs, “while downplaying known adverse and serious health risks,” Bloomberg reported.

In March 2014, the multidistrict litigation panel received a motion to consolidate all federal testosterone lawsuits, including the AndroGel lawsuits, in federal court in Illinois.

If you took AndroGel or any other testosterone drug and suffered a heart attack, stroke or blood clot, you may be entitled to compensation. Drugwatch can help you find a qualified attorney.

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