Cialis Lawsuit
What is Cialis?
Cialis (generic: tadalafil) is used to treat erectile dysfunction (ED) and enlarged prostate (benign prostatic hyperplasia). The drug belongs to a class of medications called PDE-5 (Phosphodiesterase type 5) inhibitors that enhance the erectile response when a man is sexually stimulated by relaxing the smooth muscle in the prostate and bladder. Cialis is made by Eli Lilly & Co., and was approved by the U.S. Food & Drug Administration (FDA) in November 2003.
What’s the Problem?
Cialis works by inhibiting the enzyme PDE5. The problem is that recent studies have found that melanomas become more aggressive when PDE5 is blocked. About 50% of melanomas have mutations that inhibit PDE5 and make the disease more invasive.
Cialis Skin Cancer Studies
- A January 2011 study published in Cancer Cell found that blocking PDE5 — the mechanism of action in Cialis — made melanoma skin cancer more invasive.
- In August 2012, another study published in the Journal of Cellular Biochemistry determined that the same mechanism exacerbated development of skin cancer. About half of all melanomas have a genetic mutation that inhibits PDE5, which led the researchers to question whether PDE5-inhibitors like Cialis also make conditions more favorable for melanoma.
- JAMA Internal Medicine study published in June 2014 finds a 84% increased risk of melanoma skin cancer with sildenafil, the active ingredient in Viagra. The findings were based on a study of more than 25,000 men conducted over nearly a decade.
FDA Investigating Skin Cancer Risk with ED Meds
The FDA announced in June 2016 that it was evaluating whether melanoma warnings should be placed on labels of Cialis, Viagra and other similar erectile dysfunction medications.
Cialis Skin Cancer Lawsuits Filed Against Eli Lilly
In August 2016, 7 men who claim they developed melanoma skin cancer after using Cialis filed lawsuits against Eli Lilly in the U.S. District Court, Southern District of Indiana. The complaints allege that the company failed to adequately warn doctors and patients about a “significant risk of exacerbating melanoma” on the labeling of Cialis.
Cialis Side Effects
- Melanoma skin cancer
- Changes in vision / sudden vision loss
- Ringing in the ears (tinnitus) / sudden hearing loss
- Chest pain or heavy feeling
- Pain spreading to the arm or shoulder
- Nausea
- Sweating
- General ill feeling (malaise)
- Irregular heartbeat
- Shortness of breath
- Swelling in the hands or feet
- Seizure (convulsions)
- Feeling light-headed
- Fainting
- Penis erection that lasts 4 hours or longer (priapism)
- And more
What is Melanoma Skin Cancer?
The most dangerous form of skin cancer, melanomas develop when unrepaired DNA damages skin cells and triggers mutations, which causes the skin cells to multiply rapidly and form malignant (cancerous) tumors. These tumors originate in the pigment-producing melanocytes in the basal layer of the epidermis. Melanomas often resemble moles, and some develop from moles. Most melanomas are black or brown, but they can also be skin-colored, pink, red, purple, blue or white.
Warning Signs: The ABCDEs of Melanoma
The “ABCDE” warning signs of melanoma skin cancer include:
- Asymmetry – One half of the mole doesn’t match the appearance of the other half.
- Border irregularity – The edges of the mole are ragged, notched or blurred.
- Color – Pigmentation is not uniform. Shades of tan, brown and black are present. Dashes of red, white and blue may add to a mottled appearance.
- Diameter – The size of the mole is greater than 1/4 inch (6 mm), about the size of a pencil eraser.
- Evolution – There is a change in the size, shape, symptoms (such as itching or tenderness), surface (especially bleeding) or color of a mole.
Cialis Timeline
November 2003 – Approved by the FDA
November 21, 2003 – Cialis (tadalafil) approved by the U.S. Food & Drug Administration (FDA).
January 2011 – Cancer Cell Journal study published
January 18, 2011 – Study published in the Journal Cancer Cell finds that blocking PDE5 makes melanoma more invasive.
August 2012 – Journal of Cellular Biochemistry study published
August 2012 – Journal of Cellular Biochemistry publishes a study which finds that Cialis’ mechanism of action exacerbates the development of melanoma skin cancer.
June 2014 – JAMA Internal Medicine study published
June 2014 – Study published in JAMA Internal Medicine finds an 84% increased risk of melanoma with sildenafil, the active ingredient in Viagra.
June 2016 – FDA announces investigation
June 30, 2016 – FDA announces it is investigating whether to issue warnings about the risk of melanoma with Cialis and other ED drugs.
August 2016 – Lawsuits filed against Eli Lilly
August 5, 2016 – Lawsuits filed against Eli Lilly by 7 men who claim they developed melanoma skin cancer after taking Cialis.