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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

AndroGel, Low Testosterone Lawsuit Information

[UPDATE: 03/03/2015 – The United States Food and Drug Administration has required testosterone supplement (Low T) packaging to include information regarding the increased risk for stroke and heart attack linked to these drugs.  Manufacturers will also be required to caution patients Low-T drugs are only approved for men with specific ailments, as many of these drugs are overused. For more information, see the Low-T Safety Alert by the Food and Drug Administration and this New York Times article.]

WARNING: Research shows AndroGel (testosterone gel) and other “low-T” drugs are associated with a dramatically increased risk for serious injury including heart attack, stroke, and death, prompting a number of AndroGel lawsuits to be filed against Abbott Laboratories, Inc. and AbbVie, Inc., the manufacturer of AndroGel.

AndroGel is marketed to men for the treatment of low testosterone (Low T).  Unfortunately, the prevalence of Low T is much lower than the manufacturers of AndroGel and other Low T drugs would like to the population to believe, and as a result many men use Low T drugs without cause and therefore face these risks without reason.

Due to the fact that AndroGel manufacturers failed to adequately warn of the risk for heart attack, stroke, and death associated with AndroGel, and that the drug was marketed improperly, several large lawsuits against these companies are currently underway.

If you or a loved one used AndroGel and suffered an adverse cardiac event, please do not hesitate to contact our team of AndroGel attorneys at Justinian PLLC for a free, no-obligation AndroGel lawsuit consultation.
(855) 452-5529
justinian@justinianpllc.com

Cardiac Side Effects Linked to AndroGel

Here, I will outline some of the medical research showing AndroGel risks and further detail problems with the award-winning AndroGel marketing campaign.  Let’s start with the science.

In 2014, a study was published in PloS One titled “Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men.” found that the overall risk for heart attack was 36% greater in men who used testosterone therapy.  In men over 65, the risk for heart attack was more than twice that of non-users, and in men over 75, the risk for heart attack was more than three-times that in non-users.

Last year, a study appearing in Journal of the American Medical Association (JAMA) titled “Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels.” studied 8,709 men with Low T (of which 1,223 patients used testosterone therapy drugs), and found that 27.5% of men using testosterone therapy suffered serious adverse cardiac events, compared to only 19.9% of unmedicated men in that same period.  The team concluded “the use of testosterone therapy was associated with increased risk of adverse outcomes”. (emphasis added)

A 2014 paper titled “Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men” determined that the use of testosterone therapy drugs doubled the risk for heart attack in men older than 65 and in younger men who had history of heart disease.

Here is an excerpt from one of the current AndroGel lawsuits:

“In 2000, when the FDA approved AndroGel, the company announced that the market was ‘four to five million American men.’ By 2003, the number increased to ‘up to 20 million men.’ However, a study published in the Journal of the American Medical Association (‘JAMA’) in August 2013 entitled ‘Trends in Androgen Prescribing in the United States, 2001-2011’ indicated that many men who get testosterone prescriptions have no evidence of hypogonadism. For example, one third of men prescribed testosterone had a diagnosis of fatigue, and one quarter of men did not even have their testosterone levels tested before they received a testosterone prescription.”

Does it really seem likely that the prevalence of hypogonadism would quadruple in three years, or does this simply look like a case of improper marketing?  It is interesting to note that when then-manufacturer of AndroGel, Unimed Pharmaceuticals, Inc., first sought AndroGel approval by the FDA in 1999, “hypogonadism was estimated to affect approximately ‘one million American men.’”  A twenty-fold increase in disease prevalence is staggering, and would represent an epidemic if it were real.  Thankfully, it isn’t.

Further, it has been alleged that AbbVie and Abbott Laboratories “misrepresented and continue to misrepresent to the public and to the medical profession that the drug AndroGel is safe and free from serious side effects,” and that these companies “have fraudulently concealed facts and information that could have led [our client] to discover a potential cause of [the side effects experienced].” (emphasis added)  These are central reasons why many AndroGel lawsuits and Low T lawsuits have been filed.

AndroGel Lawsuits

If you or a loved one used AndroGel or another Low T drug and suffered negative side effects including heart attack or stroke, or if a loved one died while using AndroGel, you may be entitled to significant financial compensation from the manufacturers for your undue injury.

For a free, no-obligation AndroGel lawsuit consultation, please do not hesitate to contact our team of AndroGel lawyers and Low T lawyers at the information provided below.  Our AndroGel attorney team has the compassion, experience, and resources to fight for the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529
justinian@dangerousdrugs.us