Testosterone Products

There are several ways a patient can administer the drug. Depo-Testosterone and Testopel are both injections. These require the patient to return to the doctor every few weeks. Androderm is a patch that the patient can apply before bed at night. Testim, Fortesta, Androgel and others are gel forms of the drug. These can be applied via a roller similar to underarm deodorant.

Due to their ease of application, no repeat doctor visits, and no patches to worry about, gel applications have rapidly become the most popular form of using testosterone boosting drugs. Combine their ease of use with heavy marketing on the part of the drug company, and it is easy to see why most men are opting for the gel version of the drug.

However, the gels come with their own precautions and warnings that may not be applicable to the other versions of the drug. For instance, it takes time for the drug to be absorbed into the skin. During that time there is a risk of it transferring to a loved one via touch. If the drug is transferred to a female, or a young child, the results could be serious medical problems for the recipient.

However, the biggest concern with gel testosterone is the fact that the patient is being put at risk of serious side effects. In January, 2014 a study was published that indicated users of testosterone boosting drugs were at an increased risk of heart attack, blood clots, stroke and even death. This study spurred the FDA to start investigating these claims.

The drugs have been in the news so much lately, that the FDA has also recently required that another warning be placed on their label. While the label already contains a warning about blood clots due to polycythemia, or elevated red blood cell count, the label will now contain a general warning about the risk of blood clots.

Nearly 20 years ago the FDA approved Androderm for public use.  This drug was one of the first to replace the traditional method of testosterone injections by allowing the patient to absorb the drug through the skin via a patch that is worn for 24 hours before being replaced.  While more convenient than an injection, the drug’s sales still lag behind those of AndroGel and Testim (both are gel forms of the drug) due to their ease of use.

This is not to say that the drug is a poor seller.  It is still one of the most popular drugs on the market despite a price tag of around $380 per month.  In fact this drug alone is responsible for helping bring in over $87 million for the parent company Actavis in 2012.

The downside, however, is that Actavis never fully warned patients about the full risk of using their product.  The Androderm patch, like all Low T drugs, is very effective at helping to offset the feeling of growing old.  The patient will have more energy, feel stronger, notice an increase in sex drive, and many other positive side effects.  However, they will also be subjecting themselves to an increased risk of heart attack.  One study found that risk increases even more with a higher dose, prolonged use, or as the age of the male increases.

Due to the risks of using this drug, the FDA launched an investigation in early 2014 to determine if it is actually safe to use.  The FDA also issued a warning in June 2014 that all Low T drugs must carry a warning on their box about the risk of blood clots.  This blood clot warning did not coincide with their investigation, but was the result of a previous red flag.

The Company

Actavis started out operating under the name Watson in Indiana back in 1984. For the next 28 years they researched and developed pharmaceuticals becoming one of the largest manufacturers of generic drugs in the world. In 2012 they acquired a Swiss company named Actavis Group. Watson took on the name Actavis to better sell to the global market.

Actavis has a worldwide reach, and this reach has allowed them to bring in revenues of $5.91 billion during the calendar year 2012. This gives them a ranking of 26th largest pharmaceutical company worldwide.

A portion of their revenues were brought on through the sale of the Androderm patch. In 2011 this low T treatment helped to increase the revenue for the company by $87 million.

The Drug

The Androderm patch was initially approved for use by the FDA back in 1995. This makes it one of the oldest low testosterone treatments out there. Yet it is still behind others such as AndroGel and Testim in terms of sales. This could be because many of the testosterone therapies are applied as a gel. Androderm is a patch that the patient wears. It comes in either 2mg or 4mg and the patch is placed in a discrete location on the body. The patch is worn for 24 hours until it is replaced with a new patch.

Androderm is actually one of the cheaper testosterone drugs available. However, 30 applications still cost $380.

The Company

Founded in 1888, Abbott Laboratories is one of the oldest pharmaceutical companies in the US. In the past 126 years they have gone from being a drug store serving a local market on the north side of Chicago, to a company that operates in over 130 countries around the world. In 2011 the company split into Abbott Laboratories that focuses on medical innovations, and AbbVie that focuses on pharmaceuticals.

Abbott Laboratories is also one of the largest pharmaceutical companies doing business in the US. Overall the company had nearly $40 billion in revenue sales ranking them as 7th overall.

That revenue was brought in by all of the medical and pharmaceutical developments. Sales of AndroGel represent $1.33 billion, or about 3.3%, of the company’s revenue.

The Drug

AndroGel comes in two strengths, 1% and 1.62%. It also comes in two delivery methods: pump or pre-measured packets. The drug does not come cheap either. A 30 day supply of the packets will cost the patient nearly $400.

AndroGel does not claim to come without side effects either. Listed on the FAQ’s page of the AndroGel website the side effects include some serious consequences. Including increased risk of prostate cancer, lower sperm count, problems breathing during sleep (sleep apnea), and blood clots in the legs. Some of these risks are so serious (including heart disease, which is not mentioned on the AndroGel site), that the FDA has started an investigation into whether testosterone supplements are even safe for use.

In 2000 Androgel was approved by the FDA.  It was one of the first testosterone drugs to break away from the injection style treatment; instead it is applied via a topical gel.  This gel is rubbed onto the upper arms and shoulders.  Throughout the day the drug is absorbed into the bloodstream and the male’s testosterone levels increase.

The heavy marketing by AbbVie has paid off for them.  This drug giant has pushed Androgel in the media, convincing millions of men they have Low T, and they should seek medical treatment.  That push helped to bring in over $1.3 billion in the year 2013 alone, making it the 35th highest selling drug that year.

Heart Attack, Stroke, and Blood Clots

In January 2014 a study was released that looked at hundreds of men taking testosterone boosting drugs.  This study found that those who take the drug significantly increase their risk of heart attack.  But that was not the only finding.

The study also found there are more factors that increase the risk even further.  Those who take a higher dose are even more likely to suffer from a heart attack.  Taking the drug for a longer period of time increases the risk, and as a person ages his risk increases even further.  These risks were never fully addressed by Androgel or the other testosterone supplement companies.

This study sparked an investigation by the FDA to determine if the drug was actually safe for use.  The findings of that study will be released in September 2014.

5 AndroGel Lawsuits Filed

When the FDA announced that they are investigating claims that testosterone boosting drugs are not as safe as they are advertised, there was suddenly public awareness that their health problems were not just random.  On February 4, 2014 5 men in Illinois filed lawsuits against AbbVie Inc., the company that manufactures the popular drug AndroGel.

One of the men, Kenneth Aurecchia, a retired pipefitter, noticed medical problems after using AndroGel.  Kenneth saw television commercials promoting the drug; they led him to believe he was suffering from low T and began using AndroGel.  It was not until the FDA announced they were investigating that he realized the problems were not the result of getting older, but rather the result of using a drug that was dangerous.  The court filing alleges that the use of the drug have caused him problems in his personal, physical, and emotional life.  One of the conditions stated is that he suffered from myocardial infarction, otherwise known as heart attack.

Another plaintiff, Kimberly Dula, used the drug.  As a result he suffered from three heart attacks.  He is seeking more than $75,000 in damages because he now is subjected to regular testing, a restricted diet, medication, and he is at a greater risk of further heart disease or stroke.

These are just two of the many testosterone lawsuits that are being filed.  Some are for AndroGel, some are for other testosterone drugs.  All have similar side effects, and the public was not properly warned about the severe, and potentially deadly, consequences of taking the drug.

The Company

Eli Lilly was founded 138 years ago by the chemist Colonel Eli Lilly in Indiana. Since the founding Lilly has pioneered breakthroughs in many different medications, and has allowed the company to grow to the 11th largest in the world (based on 2012 revenue). In the 1980’s Lilly developed the drug Prozac, something that has become almost a household name when talking about depression treatment.

By 2012 Lilly was big enough to be bringing in billions of dollars of revenue. They ended the calendar year with revenues topping $22.6 billion.

The company has a lot of different drugs that make up that $22.6 billion in revenue. Lilly’s low testosterone treatment drug Axiron made up $124 million of that revenue. This is an increase of nearly $70 million over 2012.

The Drug

Axiron has not been around for too long, in fact it just gained approval at the end of 2010. However, it has quickly risen to one of the most popular forms of low T treatment. The popularity is due, in part, to the ease of application. Patients simply rub the gel onto their underarms, and allow it to absorb throughout the day.

Axiron gel comes in a dispensing pump that the patient uses to fill the applicator cup. Each axilla (armpit) receives 30mg of testosterone each day. A 30 day supply of the gel will cost the patient over $400.

This drug, like other androgen (testosterone) drugs, comes with side effects. Most commonly patients experience irritation at the application site, headaches, and other discomforts. But there are some serious side effects that can occur. Blood clots in the legs, heart disease, and prostate cancer (among others) are some of the major concerns for those who are using Axiron for a prolonged period of time. The seriousness of these side effects has led the FDA to start an investigation to determine if the drug is safe enough for use.

Richard Ott’s Case Against Axiron

Richard Ott suffered from what he thought was low testosterone levels. He was experiencing some of the symptoms (fatigue, weight gain, listlessness, decreased sex drive, etc.) associated with low T, and consulted his doctor. At the age of 58 Richard was at the age many men begin to feel as though they have low testosterone, but without a blood test to prove so they may just be experiencing the signs of getting older. In October 2011 Richard began using AndroGel to help boost his levels.

Richard used this drug for a few months, however went off the drug in January 2012 when he was prescribed Axiron instead. On April 2, 2012 he started using this new testosterone drug until he suffered a fatal heart attack on April 17, 2012. He had no prior history of heart disease.

Richard Sean Ott, the son of the deceased, filed a lawsuit against AbbVie Inc. and Eli Lilly, the manufacturers of these two brands of testosterone drugs, on April 8, 2014. The claim is that the drug companies did not sufficiently warn about the dangers of taking their drug.

Cases similar to this one are popping up all over the country. They are spurred on by the FDA’s announcement in early 2014 that they are investigating the safety of using testosterone supplement drugs. This investigation was a result of a study published in January 2014 that indicated men taking these drugs are at a significantly increased risk of heart attack, stroke, blood clots, or death. In June 2014 the FDA announced they will now require a generalized warning on the testosterone label regarding the risk of blood clots while they continue their investigation.

The Company

The company started out in Jerusalem, Israel as a wholesale distributor in 1901. As the years went by, the company Teva was founded, and in the 1970’s Teva Pharmaceutical Industries was started. Teva specializes in generic drugs, and quickly rose to the ranks of one of the largest companies worldwide.

Operating around the world, but headquartered in Israel, Teva ranks #12 in revenues. In order to achieve this status they managed to bring in over $20 billion in 2012.

The Drug

Bio-T Gel saw approval in 2012 as a testosterone drug. The drug is actually made by the company BioSante Pharmaceuticals, but it is licensed to Teva for commercialization. Teva pays royalties back to BioSante on any of the sales made. The drug is not as widely prescribed as many of the other low testosterone drugs, primarily because of its late onset into the marketplace. The difference is that Bio-T Gel is being marketed as a generic. So rather than pay hundreds of dollars per month for the other drugs, Bio-T hopes to capture the market with a cheaper alternative. Unfortunately the drug is too new and there are no hard sales data available.

What is available, however, is the fact that testosterone therapy drugs come with side effects. They range from the mild: changes in body hair, prolonged erections, and aggressive behavior. To the severe: heart disease, stroke, prostate cancer, or death.

The seriousness of these side effects had not been studied thoroughly before low testosterone treatment drugs were put on the market. However, some recent studies, such as one published in January 2014 by Plos One, show that there is a significant increase in the risk of heart disease for those who use them.

The Company

Endo began in 1920 as the company Intravenous Products of America, Inc. They took on the name Endo Products in 1935. DuPont Merck acquired the company in the year 1970, and Endo Laboratories became its own separate division in 1994. When 1997 rolled around, the two companies split completely. Based in Malvern, Pennsylvania Endo manufactures quite a few popular pharmaceutical drugs. If this looks familiar, Endo also produces the popular Low T drug Fortesta.

During the calendar year 2012, the company found its way to the 42nd place on the list of the top 50 pharmaceutical companies. Through the development and sale of drugs, Endo brought in a little over $3 billion that year alone.

The entire company managed to earn over $3 billion, but the sales of Delatestryl did not have a big part of those earnings. This particular drug is used less often than many of the other testosterone supplement drugs, primarily due to the method of administration.

The Drug

Endo Pharmaceuticals acquired the drug from Savient back in 2006. Starting in 2008 they began marketing it as their own. Under their agreement they were to pay Savient royalties off of the sale of the drug. These royalties were over $6.5 million by the end of 2008, however, the drug has slipped from popularity in recent years. The main reason is that Delatestryl is injected into the buttocks, rather than applied in gel form as many of the other Low T drugs are. However, at around $40 for a one month supply, it is vastly cheaper than the gel forms.

Delatestryl has its share of side effects. Many are the same as others, but there are some peculiar to the injection style drug. Many patients experience a bitter taste in the mouth, hair loss, headache, and gum pain. Some of the severe side effects include jaundice, breast growth, gingivitis, as well as the recent research showing an increase in heart disease.

The Company

Pfizer is one of the most well known brands in the pharmaceutical industry. They began in 1849, and through the past 165 years they have made many drugs for many different ailments. They shot to fame in the late 1990’s with their erectile dysfunction drug, Viagra.

The company is no small matter. On the list of the top 50 pharmaceutical companies, they rank second bringing in over $58 billion in 2012; trailing only Johnson and Johnson. With such a wide array of drugs, they rely on many of them to help build their empire.

Their testosterone therapy drug, Depo-Testosterone, helps add to their revenue.

The Drug

Depo-Testosterone has been around for nearly 35 years. It was originally developed by Pharmacia and Upjohn. A merger in 2003 saw Pharmacia and Pfizer operating as one company, creating one of largest pharmaceutical companies in the world. Even though the drug is one of the oldest on the market, since it is administered via injection every 2 to 4 weeks, it is relatively unpopular. Many of the men who use testosterone supplements prefer ease of application, thus the gels applied to shoulders or underarms are very popular.

Despite the application method, and despite the length of time that the drug has been on the market, there are still concerns with taking drugs to combat low T. Using a testosterone boosting drug, even for as short a period as 90 days, can increase a person’s risk of heart disease, stroke, gynecomastia (development of breasts in males), prostate cancer, or even death.

The Company

Endo started its journey in 1920 as a company called Intravenous Products of America, Inc. In 1935, the company changed its name to Endo Products. In 1970 DuPont Merck acquired the company, and in 1994 Endo Laboratories became a separate division of DuPont. The year 1997 saw the companies split completely. Endo has grown adding many new drugs to its repertoire, and it calls Malvern, Pennsylvania home to their headquarters.

Endo is on the list of the top 50 pharmaceutical companies. For the calendar year 2012, this company came in 42nd place with revenue of just over $3 billion. While they are substantially smaller than those at the top of the list, they are amongst the largest worldwide.

Revenues for the entire company were just over $3 billion, but those were bolstered by the sales of their low testosterone drug Fortesta. This drug accounted for $30.6 million of that revenue for 2012 (Fortesta more than doubled in sales from 2011 to 2012).

The Drug

Fortesta Gel is one of the newest treatments of low testosterone. It gained FDA approval in late December 2010. Like many other low T treatments, Fortesta is a topical gel. This gel, however, is applied to the inner thigh instead of the upper arms and shoulders.

Other low testosterone gel treatments have a lower concentration of testosterone. Since Fortesta comes with a 2% concentration of testosterone, less is needed in each application. Just like the other drugs, however, Fortesta costs nearly $400 for 30 applications.

Also like the other low T therapies, Fortesta carries some serious side effects. The front page of the website lists the important safety information. The site includes side effects such as increased blood calcium levels, sleep apnea, increased risk of prostate cancer, and others. These side effects are so serious, that the FDA has launched an investigation to determine if this drug (and others like it) is even safe to use. With research showing that prolonged use of low testosterone drugs can lead to heart disease, stroke, and even death, the use of Fortesta should be not be taken lightly.

Demetric Taylor’s Fortesta Lawsuit

Fortesta Gel is one of the leading testosterone products on the market. This easy to use gel is generally applied to the underarms for men who are trying to boost their testosterone levels, and restore their youthful vitality that seems to have diminished as they grow older.

Demetric Taylor is a resident of Georgia who used Fortesta Gel. This drug, manufactured by Prostrakan Group out of the UK and licensed for sale in the US by Endo Pharmaceuticals, has become the defendant in a testosterone lawsuit. After viewing the advertisements that claim fatigue, increased body fat, and listlessness (among others) are signs of low testosterone, Demetric obtained a prescription for the drug that he thought was a safe way to help fight the signs of aging. While the drug was effective at making Demetric feel better, it also caused him to suffer from a heart attack.

Demetric, along with his wife, filed a lawsuit against the drug manufacturer on May 12, 2014 seeking compensation for the pain and suffering that he endured while using the drug.

Demetric’s case is just one of hundreds, if not thousands, that are being filed and are currently being investigated. While his case is against the company that makes Fortesta Gel, there are many other brands of testosterone therapy drugs currently on the market. Each brand of the drug has the same negative side effects, and the same potentially fatal consequences when used.

These side effects are so severe that the FDA has started an investigation. Based on the studies that were published early in 2014, the FDA started to investigate the claims that testosterone gels were linked to an increased risk of heart attack, blood clots, stroke, and death. In June 2014 the FDA revised the warning labels that are required on the drugs to include a generalized warning about the risk of blood clots. This warning revision is not a result of their investigation, which is still ongoing.

Testim is one of the oldest drugs that Auxilium produces. In November of 2002 the drug was approved by the FDA for the treatment of low testosterone. Like many testosterone therapy drugs, Testim comes in gel form and is applied to the shoulders and the upper arm area. Testim comes in separate 50mg tubes; each tube is one day’s treatment for the initial dosing. If a patient’s testosterone levels do not come up, their doctor may increase the dose to two tubes per day. A 30 tube supply costs over $400.

Testim, like all low T treatments, comes with the risk of side effects. The front page of the website has a long list of important safety information. Included in this list are the possible side effects. The more serious consequences of using Testim include: increased risk of prostate cancer, blood clots in the legs, swelling of feet and ankles, and sleep apnea. What is not included is the fact that many people who take testosterone supplements experience a higher risk of heart disease, even if they do not have a history of heart disease. These serious side effects have caused the FDA to launch an investigation to determine if this drug is even safe for use.

The Company

Testim is manufactured by Auxilium, a company that got its start at the end of the 20th century. Sales of Testim make a lot of money for the parent company.  In just the 3rd quarter of 2013 global sales of this drug brought in over $52 million; which represents about half of the total sales for the entire company.  Heavy advertising and a strong push for the drug has paid off for Auxilium.

Those high profits, however, come at a price to those using the drug.  Testosterone supplements are currently the issue of a lot of press.  In 2013 and 2014 there were several studies published that showed these drugs were not as safe as the drug company would like you to believe.  One study from 2013 found that taking Low T drugs significantly increased the risk of having a heart attack.  That study was confirmed in another study published in 2014.  These results caused the FDA to launch an investigation as to the safety of these drugs; the results which will be published in September 2014.

What You Can Do

If you are currently taking Testim testosterone supplements (or any other brand of supplement) you should talk to you doctor about the increased risk of suffering from heart attack, stroke, blood clots, or even death.  While these side effects are rare, there are certain risk factors that increase the likelihood of suffering from them.

If you have already suffered from one of these adverse side effects, you should get in contact with a Testim lawyer from Arentz Law Group.  The highly trained lawyers want to talk to you regarding your Testim use, and what exactly happened.  You may be able to take part in a Testim lawsuit to recoup medical expenses and other damages.

Testopel is perhaps the oldest testosterone drug on the market. It first found FDA approval back in 1972 after being developed by Slate Pharmaceuticals. Since then it has been passed around, ending up in the hands of Actient. Auxilium purchased the company Actient in 2013.

While many of the testosterone therapy drugs are topical gels, applied to either the shoulders or the underarms, Testopel is different. Consisting of a small pellet, Testopel is inserted underneath the skin, and the slow release capsule provides 3 to 6 month of testosterone to the recipient. The benefit for the patient is that there is no chance of the gel rubbing off on loved ones inadvertently. Testopel is slightly cheaper than the gel forms, but will still run the patient around $300 per month.

Just like all other testosterone treatments, Testopel has some serious side effects. While there are some minor side effects, including prolonged erections, and irritation at the insertion site; there are also the major side effects. Heart disease, stroke, blood clots, and types of cancer have been reported in recent studies regarding the drug. These studies have spurred an FDA investigation to determine if Testopel, and other testosterone drugs, are even safe for use.