Abbott Laboratories has been hit with five different product liability lawsuits in recent weeks from men who claim they suffered heart problems and blood clots caused by AndroGel, the pharmaceutical company’s testosterone replacement drug.
The AndroGel lawsuits were filed in a Chicago federal court on Feb. 4, four days after the U.S. Food and Drug Administration (FDA) announced that it was reexamining testosterone replacement drugs due to two studies that were recently released showing an increased risk of heart attack and stroke in men who take testosterone.
The men who filed the AndroGel lawsuits are between the ages 50 and 63. Three alleged that they had heart attacks while using AndroGel, one had stroke, and the other had a mini-stroke, according to the complaints.
According to the product liability lawsuits, Abbott and its spin-off company AbbVie “deceived potential AndroGel users by relaying positive information through the press, including testimonials from retired professional athletes” that also included statistics giving the impression that there was need for drugs among men in the greater population. However, Abbott downplayed “known adverse and serious health risks.”
The men allege that Abbott hid from the public AndroGel’s “serious propensity” to harm when marketing the drug from 2010 to 2012.
The FDA announced on Jan. 30 that it was examining previously approved testosterone replacement drugs to look to see if there is an increased risk of stroke, heart attack and death in men that took them.
“We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy,” the FDA said in a statement.
The agency added that it “has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack or death. Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their healthcare professionals.”
However, the FDA said that doctors need to assess if “the benefits of FDA-approved testosterone treatment is likely to exceed potential risks of treatment.”
One new study recently released found that men who partake in testosterone therapy have an increased risk of experiencing a heart attack, stroke or death.
The study was done at the Veterans Affairs Eastern Colorado Health Care System and published in theJournal of the American Medical Association found that the veterans included in the study that were undergoing testosterone therapy had a 30 percent higher risk for an adverse cardiovascular event.
Researchers looked at the health records of 8,709 men who had low levels of testosterone and also had a coronary angiography, which is a test that looks for plaque buildup in blood vessels among patients, between 2005 and 2011 in the VA health system. The study compared men in that group who were undergoing testosterone therapy to those who weren’t.
Another study was published in late January that showed an higher risk of heart attack for men who were under 65 and had a history of heart disease as well as in men who were over 65 and didn’t have a history of heart disease.
The study was published in the journal “PLOS One” and was conducted by experts from Consolidated Research, the U.S. National Cancer Institute, and the University of California, Los Angeles. The researches found that after undergoing testosterone therapy for 90 days, the heart attack risk in the men doubled.
In general, Androgel heart attack lawsuits are filed individually by each plaintiff and are not class actions.
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