The popular erectile dysfunction (ED) drug Viagra has recently been found to cause an increased risk of developing melanoma skin cancer. The manufacturer, Pfizer, never warned the public about this risk. If you, or someone you love, have taken Viagra, and you have been diagnosed with melanoma, you may be entitled to compensation.
Contact a Viagra attorney from Arentz Law Group P.C. today to schedule your free initial consultation by calling 1-800-305-6000 or by filling out the contact form on this page.
What is Viagra?
In 1998 the pharmaceutical giant Pfizer released a breakthrough drug. Viagra gave hope to millions of men who were suffering from erectile dysfunction; until that time there was little to nothing on the market that could help with their problem. The drug was immediately popular surging into homes around the country not only through prescriptions, but also via pop culture. It was featured on many different shows, ads, and news programs helping Pfizer bring in nearly $30 billion in the year 2000 (more than double their revenue for 1998). But the drug was not completely safe from the start.
How Viagra Works
When a person wants to move a part of their body, the brain sends a signal to the muscle in that area. The muscle contracts or relaxes, and that area of the body moves. However, the penis does not contain muscles the same way the rest of the body does.
Instead, the penis moves (becomes erect) through pressurization. When the penis is in its limp form, the arteries that supply blood to the two main “caverns” are constricted, not allowing blood to flow into the penis. In order to relax these arteries, the brain needs to send a signal that relaxes the muscles around the arteries. To do so a complex series of chemical reactions is set in motion. As the arteries relax, blood flows into the penis and “pressurizes” it in order to produce an erection.
When the brain sends the signal that the man is no longer aroused, the chemicals return to normal and the muscles around the arteries again contract. This contraction cuts off the blood to the penis, and the blood subsequently drains through the veins.
Basically speaking the way a man becomes aroused is when the arteries open up allowing blood to flow into the penis. When someone is suffering from erectile dysfunction, the arteries and veins are not functioning properly, thus not allowing the blood to flow into the penis.
Before Viagra the only way to open up the arteries (that is to relax them so blood can flow through) was by injection. Injecting a smooth muscle relaxant into the area would cause the arteries to relax their constriction, and thus allow the blood to flow into the penis. However, there were, and still are, very few men who want to go through the process of injection every time they need to get an erection.
For those without ED the process starts in the brain. The brain sends a signal through the nervous system causing a chain reaction of various chemicals. These chemicals stimulate the smooth muscles (involuntary muscles) around the arteries to either contract or relax. When they relax, blood flows into the penis. However, for those with ED, there is a disconnect in the chemical signals from the brain. The brain knows that it is aroused, but the arteries are not fully relaxing.
Viagra works in order to increase the amount of a certain chemical, one that is really only found in the penis, so that the arteries will expand and a longer lasting erection is obtained. Once the drug wears off, and the man is no longer aroused, the chemical balance reverts to a normal, non-aroused state.
The History of Viagra
In the late 1980’s scientists working for Pfizer developed the drug sildenafil citrate. They thought they were onto the next big thing as far as treatment of heart disease goes. Over the next several years they discovered that the drug did not help with heart disease, but the test subjects found that they were having longer and more frequent erections. By 1998 Pfizer had FDA approval for the next big thing in impotency treatment. Viagra hit the markets in April of that year.
In just the first few weeks, thousands of men were prescribed this new drug to help treat their erectile dysfunction. The drug was an immediate money maker for Pfizer, even with each pill costing around $7 in 1998. Today, the price per pill has risen to over $22.
Viagra's Popularity
For the first 5 years, Viagra was the only erectile dysfunction drug on the market. Pfizer controlled the market and was able to see billions of dollars come in as millions of men each year were prescribed the drug. By 2003, however, other drugs were being developed, and Pfizer lost some market share. They were by no means struggling however.
Even today, more than 15 years after the drug initially debuted, there are millions of prescriptions written each year. In fact, the Viagra website boasts that more than 23 million men have tried Viagra since it gained FDA approval. And although there are several other drugs on the market that have the same outcome, Viagra remains the most prescribed of the three major drugs for impotent men.
However, despite the drug’s popularity, there are problems that can arise with its use. Those problems are more than just the headache or flushed face and chest that the drug company claims to be the most common side effects.
Viagra’s Side Effects
All drugs have side effects; some are more serious than others. Viagra is no exception. Some of the less severe side effects include:
- Stuffed up nose
- Headache
- Upset Stomach
- Back Pain
- Warmth or redness of the face, neck, and chest
But there are even more side effects that could have potential long-term consequences including:
- Sudden blindness
- Irregular heartbeat
- Shortness of breath
- Light headedness or fainting
- Erections lasting longer than 4 hours
- Melanoma skin cancer
- Cardiovascular problems
When the drug first came onto the market, there were reports that men taking the drug suffered from heart attacks. Subsequent research has shown that those heart attacks could be linked to Viagra use, but there is no conclusive evidence. There are studies, however, that show Viagra use is linked to a higher rate of skin cancer.
Melanoma
What is Melanoma?
Millions of people are diagnosed with cancer every year. The most common form of cancer is skin cancer, with more than 2 million new diagnoses each year in the United States alone. Out of these cases, 120,000 of them are melanoma cases.
Melanoma occurs when the skin cells become mutated and form tumors. They are commonly seen as dark brown or black spots on the skin. However, many people may mistake these tumors for moles, and go without treatment. This leads melanoma to become the most deadly form of skin cancer. Nearly 8,800 people in the US die from melanoma each year; this represents about 7.3% of the new cases.
How Viagra Leads to Melanoma
In order to work Viagra inhibits one chemical which allows the increase of another. However, the research conducted between 2000 and 2010 that was recently published indicates that there is another, less desirable side effect of this inhibition.
When the PDG5A inhibitors (such as the drug in Viagra) go to work in the body they promote melanin synthesis. Melanin is the pigment in skin, and it is what makes one person’s skin darker than another’s.
However, this melanin synthesis may also promote melanoma development. Therefore, when a person who is taking Viagra develops melanoma, even in a small quantity, they are more prone to having the melanoma cells mutate and spread than a person who is not taking Viagra.
Melanoma is often associated with sunburns. While there are many ways for the skin cells to mutate and become malignant, exposure to the sun is the primary way. A person, who is using Viagra, even if they are now being careful in the sun, may have mutated skin cells that have essentially been lying dormant. The melanin synthesis that leads to melanoma development encourages these cancer cells to grow and spread.
Sudden Blindness
The popular erectile dysfunction medication Viagra has been linked to sudden blindness. Roughly 36 hours after their first dose of Viagra, a number of men have suffered non-arteritic anterior ischemic optic neuropathy (NAION), a condition where a lack of blood supply causes optic nerve damage which leads to vision loss. Roughly 8,000 people are diagnosed with this condition every year, and there is currently no treatment that can reverse vision loss caused by NAION. People who have NAION often describe their vision as hazy, or they have a dark shadow that obscures either the upper or the lower half of the vision in one eye. Patients over the age of 50 who already have vision or eye problems, who smoke, or who have diabetes, high blood pressure, high cholesterol, or heart disease are at a heightened risk for Viagra NAION.
The FDA updated the warning label for Viagra and similar erectile dysfunction drugs in 2007 to reflect the risk of sudden hearing loss which may affect men within a few hours of using this drug.
Attorneys Investigating Viagra Lawsuits
The Journal of the American Medical Association (JAMA) published the results of a decade long research study in April 2014. The study followed nearly 26,000 men and compared their medication use to their overall medical well-being.
In the study the researchers noted that the men who used Viagra were at an 84% increased risk of being diagnosed with melanoma. Men who had a history of using Viagra, but were no longer taking the drug, were twice as likely to develop melanoma.
The attorneys with Arentz Law Group are currently investigating these research studies, and determining if Pfizer knew about the risk yet decided not to warn the public. If this is the case, those who have suffered from melanoma may be entitled to compensation.
FDA Oversight of Viagra
In the year 2000 there were several reports of men suffering from adverse cardiovascular events while taking the drug. However, further testing revealed that these men were predisposed (already had heart conditions) before starting on the pill.
The drug didn’t see any competitors for several years. In 2003, new drugs started entering the market, and more tests were performed to see what sort of side effects ED drugs had. By 2005, the FDA had updated their labeling requirements for these drugs to include language describing eye problems such as blurred vision and sudden blindness.
In 2007, the FDA posted warnings on their website, and some FAQs regarding the claims that Viagra led to sudden hearing loss. Later that same month, the requirements for the drug’s label were revised again to include sudden hearing loss as one of the rare side effects.
In 2012 the drug marketed as Revatio, which is essentially the same as Viagra, had been on the market for 7 years as a treatment for pulmonary arterial hypertension. It was in this year that the FDA put out a warning that it should not be used in children.
In April 2014 a study was released on the Journal of the American Medical Association (JAMA) website that showed there is a link between taking Viagra and an increased risk of developing melanoma. In fact, men who take Viagra are at an 84% increased risk of being diagnosed with this relatively rare skin cancer. The FDA has yet to comment on these findings, nor have they required Pfizer to update the language on their marketing material or labeling.
Pfizer and Viagra Revenues
As of the end of 2013, Pfizer is the 4th largest pharmaceutical company in the world with revenues approaching $52 billion. In the United States, they rank second largest trailing the giant corporation Johnson & Johnson. This company, that has revolutionized the drug industry, has spent a long time building its brand. Founded in 1849, the company has been working hard for over 165 years along the way they have reaped huge profits from drugs like Viagra, Lipitor, and Zoloft.
Viagra alone accounts for a huge portion of Pfizer’s incoming cash flow. The drug hit the market in April 1998, and in April, May, and June of that year the drug had over $411 million in sales. This boom in success was in part due to the fact that the drug worked very well, but more so that there were no competitors on the market for the first several years.
Between 1999 and 2001 sales for the drug topped $1 billion. Sales increased steadily until 2003 when the first competitor came on the scene. From there, Pfizer has seen sales of Viagra drop. But not to the point where the drug is unprofitable. For the last decade Viagra has still managed to bring in more than $1 billion annually, and is expected to do so for the next several years until the patent runs out in 2019.
While Pfizer may be reaping huge profits from this one drug, many men are finding that the consequences of treating their erectile dysfunction are dire. The drug has been linked to many different severe side effects including heart problems, sudden blindness or sudden loss of hearing, and the latest report, published in April 2014, shows there is a link between taking Viagra and an increased risk of developing melanoma. Many men are suffering now, all while Pfizer continues to sell more than $1 billion worth of Viagra every year.
Contact Arentz Law
Despite the fact that the FDA has made no comment on the fact that Viagra puts men at a substantially greater risk of developing a deadly form of skin cancer, Pfizer should still be held responsible for putting millions of men at risk. The Viagra lawyers with Arentz Law know that if you took Viagra and you developed melanoma, you may be entitled to compensation. By filling out the contact form on this page, or by calling 1-800-305-6000 you can schedule your no obligation initial case review. Pfizer already put you at risk, now you deserve to be made whole.
Attorneys with Arentz Law Group P.C. can represent clients who reside in all 50 states.