Testosterone Therapy Lawsuits
FDA Investigates Testosterone Products
Early in 2015, the FDA announced they opened an investigation to research the cardiovascular complications that are accompanying approved FDA testosterone products. The FDA stated that the investigation was initiated as they received several studies revealing an increase in strokes, heart issues as well as attacks and even death while undergoing therapies. This is an indicator as to why we are seeing Testosterone Therapy Lawsuits becoming more prevalent. Contact BCN Law Firm at 855-LAW-2020 for more information or questions you have related to these therapies.
The Link Between Big Pharmaceutical Companies And Testosterone Therapy
With men experiencing low sex drives and decreased energy levels, they have been turning to testosterone therapies increasingly over the last few years. The symptoms they have experienced are in direct correlation to lower testosterone levels. While some see the new therapies as key to increased libido and vitality, some studies have linked a serious reaction causing cardiac risks associated with these drugs, especially with men who had no condition that warranted the use of them.
There was a 2013 article in the Journal of American Medical Association that correlated the use of testosterone gels with men 40 years or older– as increasing by 350 % between the years of 2001 through 2011. This is a big statistical increase, and an argument can be made that big pharmaceutical companies played a large part in marketing and growing their hormone product sales by turning natural experiences like aging into medical conditions requiring treatments like testosterone therapy. By pushing these products, it created an unnatural market and that may likely be why the number of users grew so quickly.
Research Links Testosterone Therapy To Increased Cardiac Injuries
In a six year span between 2000 to 2006 the VA initiated a study using 8,700 men in their sixties with a history of heart problems. In this group over 1200 were given testosterone therapy in different forms. According to the data, patients that underwent the therapy were thirty percent more likely to have major issues like heart attacks or strokes when compared to those who did not.
In another instance, researchers studied records of 55,000 men who received some type of testosterone therapy. They found that in the first three months of use, the risk of heart attack doubled for men younger than 65 who had a history of heart disease. The study also showed that it doubled for all men over 65 regardless of any heart disease history.
The Need To Address Testosterone Therapy
The need for these therapies may indeed give quantifiable benefits to men with low testosterone or sperm counts. When the body fails to produce enough testosterone symptoms can range from low sex drive to a lack of concentration and fatigue, and that is when men start to see the benefit in engaging these treatments. One must way the dangers in these therapies with the real life studies and look at the risks involved.
Androgel Testosterone Warning
AndroGel 1% and AndroGel 1.62% are used as prescriptions for every day testosterone replacement as a therapy. Manufactured by the AbbVie company which used to be a part of Abbott Labs. This type of gel is applied to the upper arms and shoulders directly on the skin.
Children and women who have a secondary exposure from men using the gel can show health issues. Because of this the FDA has placed a black box warning about the risks of AndroGel 1%. This especially applies to children and women in September 2009.
So far in 2014 five Androgel lawsuits have been filed in Illinois federal court against the manufacturers AbbVie Inc., and Abbott Laboratories, Inc.. The suits claim the companies concealed facts about the side effects associated with the testosterone drugs.
Different Testosterone Treatments
Over five million prescriptions were written for testosterone therapy in 2011. It produced sales in excess of two billion dollars. The standard treatments are delivered by gels ( like Androgel), patches, injections and pills. They even developed an implant to disperse the testosterone. While the treatments use the Androgel method, it also is used in the following forms:
Axiron: This solution is topical and used to treat low-t. It was manufactured by Eli Lilly with an approval in 2010 to be mass marketed. It is applies in the arm pits very much like the application you use in putting on deodorant.
Foresta: This testosterone gel is a spray applied to front and inner thighs on a daily basis. It is manufactured by Endo Pharmaceuticals with an approval for sale in 2010. Endo Pharmaceuticals warns that Foresta “can transfer from your body to others… Because of this women and children must avoid contact with any unwashed clothing or body parts
AndroDerm: A testosterone patch produced by Actavis, Inc. It is a transdermal product that delivers testosterone through skin in the back,thighs, arms and abdomen. You can buy AndroDerm in 2 strengths—either 2 or 4 milligrams. Androderm was approved to be sold by the FDA in 1995.
Bio-T Gel: This gel is for use 1 time every day and GlaxoSmithKline offered it after approval in 2012. This is very rarely prescribed by doctors.
Delatestryl: This is a testosterone injection treatment manufactured by Savient Pharmaceuticals. It was approved in 2003 for mass use. The method of transmission is injection into the buttock muscle, usually every one to four weeks. The listed side effects warns” Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (such as heart failure, chest pain, heart attack).
Depo-Testosterone: DP is an intramuscular solution for low testosterone manufactured by Pfizer in 2003. The product comes in two dosses or strengths: 100 mg or 200 mg. Pfizer states on its site that Depo-Testosterone has been “in use forover 30 years in the treatment of males with low testosterone”.
Testopel: Slate Pharamceuticals produced this as a testosterone implant. It contains about seventy five mg of testosterone and the application is under the skin. This helps release the hormone over three to six months after inserting it under the skin. Testopel was developed in the 1970s, however it was not approved until 2008.
Striant: This is a tablet with 30 mg of testosterone that slowly releases into the mucous membranes of the mouth. Made by Columbia Laboratories Inc, it was approved for use in 2003.
Testim: A gel treatment applied to the shoulders daily.
Manufacturers of the above testosterone treatments have been accused of placing profits before the safety and health of consumers by:
Not adequately researching the risk of stroke or heart attack from use, especially with men suffering from cardiovascular disease, high cholesterol, blocked arteries and other prior heart problems.
Mass marketing testosterone treatments which encouraged healthy men to seek prescription medications for “Low T”.
Testosterone Therapy Class Action Lawsuits
While many people are asking about class action lawsuits over testosterone therapies, our lawyers are exploring individual lawsuits for any men who suffered heart attacks, strokes or any other related illnesses while using the “low-T” products. BCN is a personal Injury Law Firm in Central Florida and we make it a priority to assist those who have been potentially damaged by treatments that are marketed as safe, yet show evidence of harm. If you or a loved one has suffered because of Testosterone Therapy then contact Attorney Heath Nailos today at 855-529-2020 for a free consultation*.
Testosterone Therapy Lawsuits in the Villages, Florida as well as Clermont, Orlando and South Florida. Call for free information and immediate attorney access.