Cialis Legal Information

Cialis (tadalafil) is an erectile dysfunction drug. It’s a popular PDE5 inhibitor. Millions of Americans have benefited from the drug since Eli Lilly and Company introduced it in 2003. But like many other prescription drugs, Cialis carries certain health risks.

Unfortunately, in some cases, the health consequences of taking this medication have been quite severe. The most significant risk is melanoma or skin cancer.

Here, we’ll discuss the medical complications experts have linked to Cialis. We’ll also discuss recent news about this erectile dysfunction (ED) medication, including updates on various Cialis lawsuits.

If you’ve suffered an illness after using Cialis, you may have a legal claim. Contact a product liability attorney near you to discuss your situation. An attorney can explain your legal options and recommend next steps.

What Is Cialis?

Cialis (tadalafil) is a popular erectile dysfunction drug. It helps males with the inability to achieve or maintain a normal erection by increasing blood flow to the penis. Eli Lilly and Company manufactures Cialis. The Food and Drug Administration (FDA) approved the drug in 2003. The drug competes with Pfizer’s Viagra (sildenafil citrate). But don’t confuse Cialis with the discontinued ED drug, Levitra.

The FDA later approved Cialis for treatment in men with an enlarged prostate. The FDA also approved the use of Cialis to treat erectile dysfunction and an enlarged prostate simultaneously in men who suffer from both conditions.

Side Effects of Cialis

Like most drugs, Cialis has several side effects. Most of these are minor. Unfortunately, for people with a heart condition, these side effects can be severe.

Common side effects of Cialis include:

• Headaches
• Back and muscle pain
• Chest pain
• Painful erections
• Vision problems

For patients who take nitrates for heart disease or heart failure, there’s an increased risk of the following:

• Heart attack
• Stroke
• Heart failure
• Fainting
• Sudden drop in blood pressure

Patients with the following conditions should avoid taking Cialis. Make sure you tell your doctor if you suffer from the following:

• Stroke
• Recent heart failure
• High blood pressure
• Liver problems
• Kidney disease
• Bleeding problems
• Peyronie’s disease
• Angina
• Pulmonary arterial hypertension

Always talk to your doctor about any new drug you plan on taking. They will advise you of any side effects or health risks. This is especially true when it comes to PDE drugs. While the risks may seem minor, for certain patients, they can be life-threatening.

Cialis and Loss of Vision

One of the more severe complications of taking Cialis is vision loss. Patients have reported sudden vision loss after taking Cialis and other erectile dysfunction drugs.

Sudden loss of vision can be a symptom of non-arteritic anterior ischemic optic neuropathy (NAION). In some cases, NAION can lead to permanent loss of vision. You and your family members must monitor your health while taking Cialis. If you notice any changes in your vision, see your healthcare provider immediately.

The FDA has also reported sudden hearing loss in men who have taken Cialis and other erectile dysfunction drugs. Because Cialis patients are often older men, the hearing loss may be age-related.

Researchers have yet to establish that Cialis causes hearing loss. Still, Cialis patients who experience hearing loss should contact their doctor as soon as possible.

Cialis and Skin Cancer

In 2014, JAMA Internal Medicine published a study showing that Viagra may cause skin cancer. According to the study, men who had taken Viagra and other ED drugs were 84% more likely to develop melanoma, the most dangerous type of skin cancer.

Experts have warned not to take the results of this study to heart. Some researchers say that there is a correlation between Viagra and melanoma, but that there is no proof that the drug causes skin cancer. It just shows that men who took an ED drug happened to develop melanoma at some point.

Recent Cialis Lawsuits and Multi-District Litigation

In March 2018, two plaintiffs filed suit against Pfizer and Eli Lilly. They argued that they developed skin cancer after taking Viagra and Cialis, respectively. The federal courts consolidated more than 1,000 melanoma product liability lawsuits. Judge Richard Seeborg oversaw the multi-district litigation (MDL) in San Francisco, California.

In 2019, the defendants’ attorneys argued there wasn’t sufficient evidence linking their ED drugs to skin cancer. They asked the judge for a summary judgment in favor of the drug manufacturers. Such a ruling would effectively end the litigation in favor of the drug manufacturers.

In April 2020, the U.S. District Court Judge Seeborg issued his ruling. He agreed with the defendants and dismissed the MDL.

Cialis Warning Label Updates

In the years following FDA approval of Cialis, the agency required Eli Lilly to change its warning labels. For example, in 2005, the FDA ordered drug manufacturers to add a warning about sudden vision loss.

The warning advises patients to stop taking Cialis if they experience any of these side effects.

The FDA advised Eli Lilly to add new warnings again in 2006 and 2007. On July 12, 2006, the FDA warned consumers about over-the-counter dietary supplements containing Cialis’ active ingredient. The manufacturers of these supplements failed to disclose the ingredients. This puts consumers at risk of dangerous drug interactions.

In October 2007, the FDA told the pharmaceutical companies making ED drugs to add a warning about sudden hearing loss.

January 2023: ED Medicines May Help Improve Heart Health

A study in the January 2023 issue of the Journal of Sexual Medicine found that ED medications may improve men’s health. Specifically, this study finds that men who take ED drugs are at a much lower risk of cardiovascular disease.

This new study shows that men who take Cialis and other ED patients may enjoy the following health benefits:

• 13% lower chance of a major adverse cardiovascular event
• 39% lower chance of cardiovascular disease
• 25% lower chance of death

Earlier studies have shown that ED drugs may increase a patient’s risk of heart disease. This new study may improve Eli Lilly and Sanofi’s chances of FDA approval for an over-the-counter version of Cialis.

2014: Eli Lilly Partners with Sanofi to Develop OTC ED Medications

In 2014, Eli Lilly issued a licensing agreement to rival drug company Sanofi to manufacture an over-the-counter version of Cialis. Originally, Sanofi announced that the OTC drug would be available by 2024. However, the FDA ordered the drugmaker to pause its research and development of the drug.

In May 2022, the FDA announced that it was concerned about the design of the clinical trials Sanofi had developed. As of early 2024, the study was still on hold, and Sanofi had not yet recruited any participants for its clinical trials.

Per the agreement, Sanofi will have exclusive rights to market the over-the-counter version of Cialis in the U.S., Canada, Europe, and Australia.

You Have Legal Options if Harmed by Cialis

If you or a loved one becomes sick after taking Cialis or another ED drug, seek immediate medical attention. You should also consult a lawyer to review your case. Depending on the nature and severity of your injuries, you may have a legal claim against Eli Lilly. 

FindLaw’s directory of product liability attorneys can get you started. Select your state or city to review contact and ratings information for local experts. Your search results will also link you to additional details about the attorneys’ experience with dangerous drug lawsuits. Then, reach out to a trusted legal advisor with your questions.