Viagra, Cialis and Melanoma

Have you or a loved one used Viagra or Cialis for a period of at least six months? Were you or a loved one diagnosed with melanoma while using Viagra or Cialis? You may be entitled to compensation for your injuries.

What are Viagra and Cialis?

Both drugs are used to treat erectile dysfunction (ED) in men. In 1998, Viagra (sildenafil) was the first ED drug approved by the FDA. It was originally designed to treat hypertension (high blood pressure) and other cardiovascular disease; however, scientists at Pfizer, the drug’s maker, discovered that it also caused erections. Viagra brought Pfizer over $1 billion in sales in its first year. Since 1998, the number of men diagnosed with ED has increased by 250%.

Cialis (tadalafil) is manufactured by Eli Lilly & Co. Cialis obtained FDA approval in 2003.

Both Viagra and Cialis work by inhibiting an enzyme called PDE5.

What it the Problem with Viagra and Cialis?

Simply put, studies have shown that when PDE5 is inhibited, melanomas (the most dangerous form of skin cancer) become much more invasive. In fact, roughly 50% of melanomas already have mutations that also inhibit PDE5, which only makes them more aggressive. Melanoma develops in the cells that produce melanin, a skin color pigment.

There are side effects with any drug and it’s no different with Viagra and Cialis. The common side effects include:

  • Headache
  • Flushing in the face, neck, or chest
  • Upset stomach, indigestion
  • Nasal congestion
  • Back pain
  • Muscular pain or tenderness
  • Nausea
  • Rash
  • Diarrhea

The serious side effects include:

  • Chest pain or irregular heartbeat
  • Shortness of breath
  • Swelling in the hands, ankles, and feet
  • Sudden loss of vision in one eye, impaired color perception, or blurred vision
  • Sudden loss of hearing, tinnitus, or dizziness
  • Erections lasting for more than four hours (priapism), and
  • Sudden drop in blood pressure, which can lead to fainting, heart attack, or stroke.

Men using these medications to treat ED are more likely to experience side effects if they:

  • Have cardiovascular disease
  • Are over age 50
  • Have high blood pressure
  • Have high cholesterol

The risk of developing melanoma, according to the American Cancer Society, runs at around 50% for men regardless of Viagra and Cialis use. The Society has estimated that there have been approximately 76,000 new cases of melanoma in the U.S. just this year. Around 10,000 men diagnosed with melanoma will not survive the disease.

Melanoma Symptoms

Many men have moles. They are non-cancerous (benign) skin growths that begin in the same cells that produce melanin. Actually, melanoma can even look like a mole or begin growing in a mole. This is why it’s good to keep watch for any changes in moles. If you or a loved one has moles with the following characteristics, you should see your doctor immediately:

  • Asymmetrical shape
  • Uneven edges
  • Variety of colors (tan, black, red, white, blue)
  • Larger than a pencil eraser (1/4-inch in diameter)
  • Changes over time
  • Bleeding, itching, or crusting

FDA Involvement

In 2005, the U.S. Food and Drug Administration approved label updates for ED drugs. The updates added the possibility of sudden vision loss due to a condition known as non-arthritic ischemic optic neuropathy (NAION), which involves a blockage of blood flow to the optic nerve.

In 2007, the Agency required the addition of the possibility of sudden hearing loss to the labels of ED drugs.

On June 30, 2016 the FDA made an announcement that it was investigating whether to demand warnings of the increased risk of melanoma become added to ED drug labels.

Study

The journal JAMA Internal Medicine published a ten-year study by Harvard researchers. The study began in 2000 and involved approximately 30,000 men taking Viagra (Cialis had yet to obtain FDA approval). Scientists took into consideration the participants’ Viagra use, sexual health, sun exposure history and risk of genetic skin cancer. They also tracked mole history and eye and hair color.

The scientists also tracked the development of other types of skin cancers in study participants using self-reported questionnaires. Some of the cancers the study tracked were squamous cell carcinoma, basal cell carcinoma and melanoma. Over the ten years the study ran, scientists recorded 580 cases of squamous cell carcinoma, 3,030 cases of basal cell carcinoma and 142 cases of melanoma.

Data supported their conclusion that the men taking Viagra were twice as likely to develop melanoma as their counterparts who didn’t take the drug. No link between Viagra use and increased risk of developing other forms of skin cancer was found. Furthermore, the study did not show any evidence that merely having ED increased the risk of developing melanoma. It should be noted that this study did not prove a cause/effect relationship between Viagra use and increased risk of developing melanoma. Rather, it proved that there is a link of some type between the two.

Viagra and Cialis Melanoma Lawsuits

Despite the study showing that there is some type of link between Viagra and the risk of developing melanoma, Pfizer has kept quiet. It has not warned doctors or patients of the potential risk. Though the study did not include Cialis, Eli Lilly has also remained silent about any potential connection between its ED drug and melanoma.

Men injured by Viagra have filed suit against Pfizer for failure to warn them of the possible risk of developing melanoma. In April 2016, these suits were consolidated into a multi-district litigation (MDL) in federal court in the Northern District of California, Judge Richard Seeborg presiding.

Certain of the Cialis plaintiffs asked the Judicial Panel on Multi-District Litigation (JPML) in September 2016 to combine their suits with those in the Viagra MDL due to similarity in facts of the cases. The JPML has not yet issued its decision in the matter.

The purpose of the MDL is to handle all of the pre-trial proceedings (discovery, etc.) at one time, thus saving the parties time and money and avoiding the risk of contradictory pre-trial decisions.

It is quite possible that the future will bring suits regarding Levitra (vardenafil) and the increased risk of developing melanoma. Levitra is another ED drug manufactured by GlaxoSmithKlein and Bayer Pharmaceuticals. Depending on the number of Levitra cases filed, there may be another motion filed with the JPML to add these cases to the Viagra MDL.

Don’t Wait! The Time is now to Seek Legal Assistance!

If you or a loved one has been diagnosed with melanoma after using Viagra or Cialis for at least six months, now is the time to seek legal assistance. The Statute of Limitations, the time period during which you can file a lawsuit, may already be running. If you wait too long, you will be forever barred from seeking the justice you deserve. Contact the experienced attorneys at Justinian and Associates now for a free case consultation. We are experienced in dealing with dangerous drug lawsuits and MDLs and we will fight for you.