Cialis Recent News
By Christie Nicholson, J.D. | Legally reviewed by Oni Harton, J.D. | Last reviewed February 20, 2024
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Cialis (tadalafil) is an erectile dysfunction drug. It's like other erectile dysfunction (ED) drugs, such as Viagra and Levitra. Doctors also prescribe Cialis to patients with pulmonary arterial hypertension (high blood pressure) and benign prostatic hyperplasia (enlarged prostate).
Eli Lilly and Company manufactures this drug. The FDA approved it in November 2003. Millions of men have taken this drug over the years. But, the drug has several adverse side effects. It can also be dangerous for certain patients, especially those who take nitrates.
Here, we'll discuss recent news and research on Cialis. We will also briefly explain what to do if you suffer harm after taking Cialis or any other erectile dysfunction medications.
Cialis Side Effects
Cialis is a phosphodiesterase type 5 inhibitor (pde5 inhibitor.) It works by blocking the production of an enzyme that regulates blood flow to the penis. Other popular PDE-5 inhibitors include:
- Viagra (sildenafil)
- Revatio
- Alyq
- Adcirca
- Levitra (vardenafil)
These drugs share similar adverse side effects.
It's important to discuss the side effects of Cialis before diving into recent news. Millions of Americans take this prescription medication. Most patients are older men who may already suffer from other medical conditions.
Some of the common side effects of Cialis include:
- Headache
- Chest pain
- Back pain
- Angina
- Myalgia
- Dyspepsia
- Vision loss
- Hearing loss
- Persistent erection (over four hours)
- Indigestion
There are no over-the-counter medications that help with ED. So, men having issues with sexual activity turn to brand-name ED prescription drugs. They must balance the risks of taking these drugs with their benefits.
They must also consider the serious health risks that come with taking Cialis. For example, studies show that Cialis patients have an increased risk of heart disease, heart failure, and heart attack.
Last year, a study found that taking ED medications may help your heart health by expanding the blood vessels in your body. It all depends on your health and medical history. We will discuss this study in more detail below.
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.
On Oct. 18, 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.
What To Do if You Become Sick After Taking Cialis
If you take Cialis or any other ED drug, you may experience side effects. If you suffer a severe adverse reaction to these drugs, seek immediate medical help. You should also contact an experienced drugs and medical devices liability attorney. They can review your claim and determine if you have a valid legal claim.
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