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If you or a family member has suffered a heart attack, stroke, pulmonary embolism, congestive heart failure, or other cardiovascular problems due to the use of AndroGel or other testosterone replacement product, contact the attorneys at Raizner Slania LLP for experts in a testosterone drug related lawsuit.
The Illinois-based pharmaceutical company AbbVie, a partner of Abbott Laboratories, manufactures AndroGel, the market leading testosterone replacement drug. Other testosterone replacement drugs include:
AndroGel received Food and Drug Administration (FDA) approval in February 2000 as a topical medication prescribed to treat men who suffer from hypogonadism, also known as low testosterone or “Low-T.”
Hypogonadism affects approximately 4 to 5 million American men, and typically presents the following symptoms:
AndroGel is applied directly to the skin of the shoulders, upper arms, and/or abdomen and allowed to gradually enter the bloodstream, where it delivers the testosterone over a 24-hour period. Some common side effects from AndroGel use include:
Abbott Laboratories is said to have spent $80 million marketing AndroGel in 2012, and sales of the product increased from $650 million in 2010 to $1.2 billion in 2012.
According to at least one National Public Radio article, “[t]he number of testosterone prescriptions written in the U.S. more than tripled in the past decade. But researchers suspect that much of the testosterone dispensed at low-T clinics isn’t tracked, since it’s often bought with cash. This unfettered flow of testosterone — officially a controlled substance — has raised concerns among doctors who specialize in hormonal problems.” Sales of all testosterone-boosting drugs are estimated to have been $2 billion in 2012, and are projected to hit $5 billion by 2017.
The FDA has reported heart attacks, pulmonary emboli, cerebral vascular accidents, and even deaths associated with the use of AndroGel, according to reports submitted through its Adverse Event Reporting System. A number of studies have raised concerns about the health risks of using AndroGel, yielding some disturbing results:
In 2010, the New England Journal of Medicine published a study entitled, “Adverse Events Associated with Testosterone Administration.” The study found that those who used testosterone gel had higher rates of cardiac, respiratory, and dermatologic problems than those who did not.
A study by Dr. Rebecca Vigen published in 2013 by the Journal of the American Medical Association suggested there is a nearly 30 percent increased risk of heart attack, stroke, and death in those given testosterone replacement therapy, particularly in patients with pre-existing heart problems.
In January 2014, a William Finkle study in PLOSOne found that testosterone replacement therapy products such as AndroGel doubled the risk of heart attack among men over 65 and tripled the risk for those under 65 with a prior heart condition.
In response to this data, on January 31, 2014, the FDA announced that it would be conducting an investigation into the risk of stroke, heart attack, and death in men using prescription testosterone therapies. On February 25, 2014, Public Citizen asked the FDA to immediately add a black-box warning about the increased risks of cardiovascular dangers to the product labels of all testosterone-containing medications available in the U.S. Recent updates to the FDA labeling and packaging of these products caution consumers of a possible increased risk of heart attack and stroke.
As of May 3, 2015, more than 1,000 testosterone lawsuits have been filed against Abbott Laboratories, alleging that the company failed to warn patients and doctors about the increased risk of serious cardiac events related to the use of AndroGel. According to court documents, one man suffered a stroke after using AndroGel, another sustained a mini-stroke, and the other three plaintiffs had heart attacks.
According to the complaints, AbbVie created a special website for AndroGel, IsItLowT.com, where men can take a quiz to determine whether they are suffering from low levels of testosterone. The quiz asks men if they are experiencing weight gain, loss of libido, energy, and/or muscle mass, symptoms that AbbVie attributes to Low-T. However, the plaintiffs’ contend that there were safer drugs available to treat these symptoms, many of which may just be the result of advancing age.
The complaints also allege that the company disregarded the public’s safety in favor of profits by coordinating a massive advertising campaign designed to convince millions of men they suffered from low testosterone. Abbott Laboratories ultimately made over $1.4 billion in profit on AndroGel sales.
If you or someone in your family has experienced cardiovascular problems resulting from the use of AndroGel or other testosterone replacement product, please contact the attorneys at Raizner Slania to request a consultation today regarding a testosterone drug lawsuit or related drug lawsuit.